28.12.2007: Constituents of printing inks in beverages from cartons [1] [2]
According to the German Federal Institute For Risk Assessment (BfR) the occurrence of a chemical in a food does not in itself constitute a risk to health. It is the harmfulness of the substance and the degree to which the consumer comes into contact with the substance that determines the scale of possible damage and the probability that it will occur. Residues of printing inks in foods may, therefore, be safe but they may equally constitute a serious risk to health.

Given the lack of data, a health assessment is frequently not possible at the present time. As the manufacturers bear responsibility for the safety of their products, they should do everything in their power to prevent the migration of substances of this kind to foods and put together the data needed for a health assessment.

The printing inks may contain the photo initiator isopropyl thioxanthone (ITX). Public agencies in Italy and Germany have detected residues of ITX in foods from cartons. Cartons for beverages like milk, cocoa or juice are often printed in different colours and have benn found to contain the ITX compound. Also olive oil has been found to be contaminated with ITX.

ITX is contained in UV-hardening printing inks. The cardboard used to make the packaging may be transported on rollers to the food filling plant and then moulded on site into the corresponding packaging. Constituents of the printing inks applied to the outer packaging material can, by means of spread (set-off), reach the inside that comes into contact with food.

Furthermore, there may be migration through the packaging material in the case of pre-moulded packaging unless effective barrier layers, e.g. aluminium foils, have been applied. BfR has examined the available toxicological data for the chemical isopropyl thioxanthone (ITX).

In line with the assessment scheme of the European Food Safety Authority and customary assessment practice at BfR and regarding substances used in the production of food commodities, the available data on the exclusion of genotoxicity are only sufficient to evaluate substances with a maximum migration level of 50 microgram/kg food. As, however, the ITX measurements in Germany revealed far higher levels, additional data would be needed for toxicological assessment. BfR does not have the necessary data on toxic effects, bioavailability or toxicokinetics of the substance.

Actions
Talks between the Plastics Committee and representatives of the printing ink industry at BfR revealed that no technology is currently available to prevent the migration of substances from printing inks to food through a set-off effect or because of penetration of the packaging material. Nor is this situation likely to change in the short term.

A larger manufacturer of beverage cartons has informed BfR that it switched to a new printing method for infant and baby food on 30 September 2005. It no longer uses any UVhardening printing inks in order to prevent migration of ITX from the package to the food. All packaging materials for milk and fat-containing products are to follow suit by 31 December 2005 and juice products by 31 January 2006.

The phenomenon of the migration of constituents from printing inks used on the outer packaging to foods as a consequence of both penetration of the packaging material and set-off to the inner packaging is a fundamental issue. Set-off cannot, in principle, be ruled out for any
packaging material processed on rollers or in stacks. Besides the data on ITX, BfR is also aware of migration findings from packaging to food for other photo initiators used in printing inks like 2-ethylhexyl-4-dimethyl aminobenzoate and 4,4’-bis(diethylamino)-benzophenone and 4,4’-bis(dimethylamino)-benzophenone. BfR is, therefore, of the opinion that there is an urgent need to lay down requirements for the use of printing inks for food commodities on the European level.

The U.S. Department of Health and Human Services (HHS) is offering a guidebook for families and households to plan for infectious disease. HHS Secretary Michael Leavitt released Pandemic Influenza Planning: A Guide for Individuals and Families January 6.

[1] Constituents of printing inks in beverages from cartons. BfR Expert Opinion No. 044/2005, 25 November 2005
http://www.bfr.bund.de/cm/230/constituents_of_printing_inks_in_beverages_from_cartons.pdf

[2] Printing inks in foods: Health assessment not possible owing to lack of data
http://www.bfr.bund.de/cd/7486


27.12.2007: Avian influenza in Brandenburg, near Berlin [1]
New cases of avian influenza by H5N1 virus were confirmed in various locations in Brandenburg, near Berlin. Health officials disposed a quarantine zone around the affected farms. All birds were culled. Cats and dogs should be kept indoor to avoid contact dead wild bird bearing H5N1 virus.

The European Union’s Standing Committee on the Food Chain and Animal Health issued the following recommendations for areas where H5N1 has been confirmed in wild birds:

•   Sick or dead cats and dogs should not be touched and the veterinary authorities should be informed, so that post-mortem examination and further testing can be performed.
•   Contacts between domestic pets, particularly cats, and wild birds should be prevented, i.e. cats should be kept indoors and dogs should be kept on a leash or otherwise restrained, and kept under control by the owner.

All pet owners are advised to stay alert to reports of H5N1 infections in either migratory waterfowl or domestic poultry in their local area and the possible need to quarantine dogs and cats accordingly.

The U.S. Department of Health and Human Services (HHS) is offering a guidebook for families and households to plan for infectious disease. HHS Secretary Michael Leavitt released Pandemic Influenza Planning: A Guide for Individuals and Families January 6. [2] Guidebook

A specific vaccine for humans that is effective against avian influenza has not yet been approved. Based upon limited data, the Centers for Disease Control have suggested that the anti-viral medication Oseltamavir (brand name-Tamiflu) may be effective in preventing or treating avian influenza.

Please see the State Department's publication "Meeting the Challenge of Bird Flu" for more background on the U.S. commitment, the science and response to bird flu. [3] Meeting the challenge

[1] Ministerium für Ländliche Entwicklung, Umwelt und Verbraucherschutz (MLUV): Vogelgrippe in Brandenburg.
http://www.mluv.brandenburg.de/cms/detail.php/lbm1.c.279974.de

[2] Guidelines for families and households to plan for infectious disease
http://www.pandemicflu.gov/plan/pdf/guide.pdf

[3] CDC: Meeting the challenge of bird flue.
http://usinfo.state.gov/gi/img/assets/5096/120105_birdflu_2.pdf

23.12.2007: Pectin[1]
E440 (i) Pectin or pectic acid
E440 (ii) Amidated pectin
The main use for pectin is as a gelling agent, thickening agent and stabilizer in food.
Pectin is present in aerial parts of plants as an important structural element, and has stabilizing
functions and controls water balance.

Pectin content of raw material
The raw material are the residues of juices, the peel off skin or trash-out of sunflower.
Pomace and sugar beet chips have around 15%, sunflower infructescence have 20% and citrus peels such as orange and grape fruit have 30% pectin. Other fruits such as mango, pumpkin, squash and vegetables such as chicory are being analysed for the production of pectin.

Pectin is used in the production of jams, confectionery articles, such as gummi bears without gelatine, baked and dairy products or in the nonfood industry, such as in cosmetics and pharmaceutics. Pectin is being highly appreciated by vegetarians, by certain ethnic groups classifying it as Halal or Kosher. It is also a response to the BSE crysis.

Pectin is a heteropolysaccharides with polygalacturonic acid as main component, partially esterified with methanol. Heteropolysaccharide are polysaccharides containing more than one type of saccharide, such as xylose, galactose or arabinose which are linked as side chains to the pectin macromolecules and the rupture of the main chain caused by rhamnose.

Classification of pectin
Pectins are divided into three groups on the basis of their different gelling properties.
In nature, around 80% of carboxyl groups of galacturonic acid are esterified with methanol. This proportion is decreased more or less during pectin extraction. The ratio of esterified to non-esterified galacturonic acid determines the behaviour of pectin in food applications. This is why pectins are classified as high- vs. low-ester pectins - or in short HM vs. LM-pectins, with more or less than half of all the galacturonic acid esterified.

High methoxyl pectin: has a degree of esterification of more than 50 % Acetylation prevents gel-formation but increases the stabilisation and emulsifying effects of pectin.

Low methoxyl pectin: has less than 50 % esterification. Its gelling properties does not depend on acid or sugar content. The salt of partially esterified pectins are called pectinates, if the degree of esterification is below 5% the salts are called pectates, the insoluble acid form, pectic acid.

Amidated pectin: is a modified form of pectin. Here, some of the galacturonic acid is converted with ammonia to carboxylic acid amide. These pectins are more tolerant of varying calcium concentrations that occur in use. Amid Pectins are produced by suspending dried pectin in alcohol and deesterified with ammonia. Amidated pectins behave like low-ester pectins but need less calcium and are more tolerant of excess calcium. Also, gels from amidated pectin are thermo-reversible - they can be heated and after cooling solidify again, whereas conventional pectin-gels will afterwards remain liquid.

Gelidification
Degree of Esterification influences gelling properties. Very high esterified pectins jellifie
quicker i.e. at higher temperatures than less high esterified pectins. They will
also form more elastic and brittle gel textures. Pectin stabilises mixed fruit yoghurt as well in layered products where they avoid the fruit part to get mixed with the yoghurt. In acidified milk drinks high ester pectins protect the protein at a low pH range during the pasteurization process

Instant pectins
Commercial instant pectins are made in a granulation process creating a porous structure, speeding the dispersion of the pectin in water.

Liquid pectine
It is a watery solution of pectin used as gelling agent in industry and home use.

Other raw materials for pectin production
Pectin extraction in the presence of alcohols [2]
Kirtchev and colleagues discussed the extraction process. They found that addition of low molecular alcohols in concentrations from 1% to 3% to the acid extraction resulted in an acceleration of extraction and increase in the pectin yield by 55–90%. Ethylene glycol, glycerol and diethylene glycol had a better effect than monohydric alcohols.
The authors concluded that the addition of alcohols resulted in a measurable increase in the pectin gel strength. Extraction time was found to be 25 minutes

Microwave pretreatment [3]
Kratchanova and colleagues found that the pretreatment of fruit raw material such as orange with microwave pretreatment led to destruction of the parenchymal cell and inactivation of endogenous enzymes of the peels. Increased pectin yields from 190% to 250% and improvement of the quality of pectin were found.

Pectin from chicory [4]
Robert and colleagues report that the maximum pectin yields of 4.65 and 4.62 per cent were obtained from the Melci and Nausica varieties, respectively, using an acidic treatment at 85 degrees Celsius.

The galacturonic acid content of pectins was reported to range from 43 to 53 per cent, with no significant differences observed during development or varieties.

Extraction and characterization of pectins from cocoa husks [5]
Mollea and colleagues investigated cocoa husks, a by-product of cocoa processing, as a source of pectins. Best yields were found by the authors with minced husks after 1 h of extraction at pH 2.5. methyl and acetyl ester contents were determined by the researchers.

Extraction and rheological properties of pectin from fresh peach pomace [6]
Pagán and Ibarz reported that highest yields of pectin from fresh peach pomace were obtained at 80°C at pH 1,20 a study of the extraction of pectin from fresh peach pomace. Rheologic properties of the obtained pectin were analysed by the authors.
Comparisons between different techniques for water-based extraction of pectin from orange peels [7]
Yeoh and colleagues found that the greatest total amount of pectin yield using microwave extraction of orange peel was 5.27% on a dry basis for 15 min of extraction at pH l,5. According to the authors, the greatest amount of material per unit time was obtained after 5 min, which was the same amount as that extracted using Soxhlet extraction for 3 h. Extraction for 5 minutes, pH 1,54 and solvent systems containing ethanol and EDTA (ethylenediamine tetraacetic acid), doubled the amount of pectin extracted as compared with distilled water extraction.

Water-based extraction of pectin from flavedo and albedo of orange peels [8]
Liu, Shi and Langrish found that the amount of pectin extracted reduces as the pH increased, and microwave extraction showed a much higher extraction rate by a factor of 120, compared with Soxlet extraction. The authors found that pectin existed mainly in the albedo, but the flavedo still contained 27% of the amount of pectin in the total extract, and 2.2% in the dried. The combination of hand-pressure and microwave on pectin yield from flavedo was 12% better were found by the authors as resulting in highest yield.

Pectins from ambarella peels [9]
Extraction and use of pectins from ambarella peels were assessed by Koubala and colleagues. The authors found that extraction with oxalic acid/ammonium oxalate solution gave the highest pectin yield, with high molar mass and degree of methylation.

Sugar beet pulp pectin extracts [10]
Extraction of pectins from sugar beet pulp in an aqueous acid medium under different conditions of pH, temperature and time were analysed by Yapo and colleagues. They found that most of the extracted pectins were surface-active, and some of them were quite able to produce and stabilize with effectiveness oil-in-water emulsions. Yield, physico-chemical characteristics and surface properties of acid extracted pectins from sugar beet pulp were found to be influenced by the extraction conditions.

Pectin from butterecup squash fruit [11]
O’Donoghue and SomerfieldI examined the gelation properties of pectins isolated from buttercup squash (Cucurbita maxima × Cucurbita moshata), flesh tissue. The authors found that extraction with HNO3 formed only weak gels, citric acid-extracted pectin were already forming solid structure at 90°C, similar to a commercial rapid-set pectin, while a sol-gel transition began for the HCl-extracted samples at <70°C, similar to a commercial slow-set pectin. Longer extraction and removal of starch by enzyme digestion affected isolated pectin chain length and esterification.

Pectic substances of Mango [12]
Kratchanova and colleagues studied the pectin composition of peels and fruit pulp of two Guinean mango varieties. The polyuronide content of the dried fruit material varied from 14·6 to 21·3% depending on the type of raw material (variety and part of the fruit) and methods of treatment prior to drying. By hydrochloric acid extraction at 85°C and pH = 1·5, the pectic substances were extracted most fully from the dried mango peels.

The following composition were found by the authors: galacturonic acid (40–70%); arabinose (2-4%); rhamnose (1-2%); xylose (1-7%); mannose (1-3%); galactose (14-22%) and glucose (8-22%).

Effect of extraction conditions on some physicochemical characteristics of pectins from mango peels [13]
Koubala and colleagues studied the extraction and composition of pectns from mango peels. The authors found that physicochemical behaviour of pectins could be influenced by the extraction .The ammonium oxalate-extracted mango pectins presented a good recovery yield, a high average molar mass and intrinsic viscosity and a high degree of methylation, and is indicated for industrially uses. or their gelling properties.

Pectins from banana peels [14]
Emaga and colleagues studied the pectin extraction of pectin from banana peels. The authors found that lower pH values negatively affected the galacturonic acid content of pectin, but increased the pectin yield. The values of degree of methylation decreased significantly with increasing temperature and time of extraction.

Pumpkin pectin extraction with enzymes [15]
Ptichkina and colleagues presented an optimised procedure for extraction of pectin from pumpkin pulp, using an enzyme preparation from Aspergillus awamori. In contrast to pumpkin pectin extraction with Bacillus polymyxa, the pectin prepared with Aspergillus awamori forms gels with 60 wt% sucrose at pH 3, although the yield is somewhat lower (14% in comparison with 22%). Some possible medicinal and food uses are suggested.

Pectin extraction from peach pomace [16]
Faravash and Ashtiani analysed the effects of acid volume, acid-washing time and pH variation during different stages of pectic substances extraction process on the yield of pectic substances isolation from dried mixed varieties of peach pomace is investigated. Ethanol-to-extract ratio (ER) as a new parameter and extract evaporation are defined to investigate their influence on the yield of pectic substances extraction. The effect of ethanol-to-extract ratio on the degree of esterification of pectic substances was determined by the Fourier transform infrared (FTIR) method.

Cholesterol removal in liquid egg yolk using high methoxyl pectins [17]
Garcia and colleagues developed a process to reduce cholesterol in liquid in egg yolk in watery solution using high methoxyl pectins The most important variables influencing the process were dilution level of egg yolk, ionic strength, and pH of yolk suspension, as well as the amount of pectin gel used in the extraction. The egg yolk contends of cholesterol and protein decreased to 14.4% and 88.6%, respectively.

[1] Wikipedia: Pectin
http://en.wikipedia.org/wiki/Pectin

[2]Kirtchev, N.; Panchev, I.; Kratchanov, Chr.: Pectin extraction in the presence of alcohols. Carbohydrate Polymers, Volume 11, Issue 4, 1989, Pages 257-263 sciencedirect

[3] Kratchanova, M.; Pavlova, E.; I. Panchev, I.: The effect of microwave heating of fresh orange peels on the fruit tissue and quality of extracted pectin. Carbohydrate Polymers, Volume 56, Issue 2, 4 June 2004, Pages 181-185. Doi:10.1016/j.carbpol.2004.01.009 sciencedirect

[4] Robert, C.; Emaga, T.H; . Wathelet, B.; Paquot, M.: Effect of variety and harvest date on Pectin extracted from chicory roots (Cichorium intybus L.). Food Chemistry (Elsevier) Published on-line ahead of print, doi: 10.1016/j.foodchem.2007.12.013

[5] Mollea, C. ; Chiampo, F. ; Conti, R.: Extraction and characterization of pectins from cocoa husks: A preliminary studyFood Chemistry, Volume 107, Issue 3, 1 April 2008, Pages 1353-1356. Doi:10.1016/j.foodchem.2007.09.006 sciencedirect

[6] Pagán,J.; Ibarz, A.: Extraction and rheological properties of pectin from fresh peach pomace
Journal of Food Engineering, Volume 39, Issue 2, February 1999, Pages 193-201 sciencedirect

[7] Yeoh, S.; Shi, J.; Langrish, T.A.G.: Comparisons between different techniques for water-based extraction of pectin from orange peels
Desalination, Volume 218, Issues 1-3, 5 January 2008, Pages 229-237
sciencedirect

[8] Liu, Y.; Shi, J.; Langrish, T.A.G.: Water-based extraction of pectin from flavedo and albedo of orange peels. Chemical Engineering Journal, Volume 120, Issue 3, 15 July 2006, Pages 203-209 sciencedirect

[9] Koubala, B.B.; Mbome, L.I.; Kansci, G.; Tchouanguep Mbiapo F.; Crepeau, M-J.; Thibault, J,_F.; Ralet, M.C.: Physicochemical properties of pectins from ambarella peels (Spondias cytherea) obtained using different extraction conditions. Food Chemistry, Volume 106, Issue 3, 1 February 2008, Pages 1202-1207 sciencedirect

[10] Yapo, B.M.; Robert, C.; Etienne, I.; Wathelet, B. Paquot, M.: Effect of extraction conditions on the yield, purity and surface properties of sugar beet pulp pectin extracts
Food Chemistry, Volume 100, Issue 4,2007, Pages 1356-1364 sciencedirect

[11] O’Donoghue, E.M. Somerfield, S.D.: Biochemical and rheological properties of gelling pectic isolates from buttercup squash fruit Food Hydrocolloids. Available online 27 July 2007 sciencedirect

[12] Kratchanova, M.; Bénémou, Cécé.; Kratchanov, Chr: On the pectic substances of mango fruits. Carbohydrate Polymers, Volume 15, Issue 3, 1991, Pages 271-282 sciencedirect

[13] Koubala, B.B.; Kansci, G.; Mbome, L.I.; Crépeau, M.-J.; Thibault J.-F. ; RaletM.-C.:: Effect of extraction conditions on some physicochemical characteristics of pectins from “Améliorée” and “Mango” mango peels. Food Hydrocolloids, Available online 31 July 2007 sciencedirect

[14] Emaga, Thomas Happi; Ronkart, Sébastien N.; Robert, Christelle; Wathelet, Bernard; Paquot, Michel: Characterisation of pectins extracted from banana peels (Musa AAA) under different conditions using an experimental design. Food Chemistry, Available online 6 November 2007 sciencedirect

[15] Ptichkina, N.M.; Markina, O.A.; Rumyantseva, G.N. : Pectin extraction from pumpkin with the aid of microbial enzymes. Food Hydrocolloids, Volume 22, Issue 1, January 2008, Pages 192-195 sciencedirect

[16] Faravash, Ram Sanati; Ashtiani, Farzin Zokaee: The influence of acid volume, ethanol-to-extract ratio and acid-washing time on the yield of pectic substances extraction from peach pomace. Food Hydrocolloids, Volume 22, Issue 1, January 2008, Pages 196-202 sciencedirect

[17]Luis A.; Freitas, Jackson F.: Cholesterol removal in liquid egg yolk using high methoxyl pectins. Carbohydrate Polymers, Volume 69, Issue 1, 1 May 2007, Pages 72-78 sciencedirect



20.12.2007: CSPI calls for more FDA funding and a modern law[1]
CSPI highlights several hot topics in food safety in their year´s report:

•   Disparities in funding. Outbreaks from FDA-regulated foods account for two-thirds of outbreaks in CSPI’s database from 1990-2005, but FDA’s food safety expenditures are only about a third of the federal food safety budget.
•   Virus-caused outbreaks. Foodborne illnesses caused by viruses have quadrupled in recent years. They accounted for just seven percent of outbreaks between 1990 and 1997, but 30 percent of outbreaks between 1998-2005. Eighty-eight percent of virus outbreaks are caused by the Norovirus, which can cause vomiting and acute diarrhea.
•    Produce-related outbreaks. CSPI identified the most common food/pathogen combinations in outbreaks linked to fruits and vegetables. Norovirus and Salmonella were the two most prevalent pathogens, with Norovirus most often affecting salad greens and fruits, and Salmonella showing up on sprouts, salad greens, melons and potatoes.
•   Unpasteurized dairy. “Raw” dairy products, even though they represent a tiny fraction of the market, were associated with 30 percent of dairy-related outbreaks, including 70 percent of milk outbreaks.
•   The CSPI urges Congress to modernize food safety laws, including consideration of legislation to establish a unified, independent food-safety agency with increased authority to recall foods and penalize violating companies. CSPI, together with the Alliance for a Stronger FDA is lobbying for increased funding for the agency.

The CSPI says that U.S. food safety laws are antiquated and were never designed to deal with modern issues such as escalating imports, bioterrorism, or tainted produce, The recent outbreaks serve as a reminder that more funding and a modern law are needed to protect the food supply.

[1] CSPI: Produce and Poultry Top Causes of “Illnesses Linked to Outbreaks”. December 20, 2007
http://www.cspinet.org/new/200712201.html

20.12.2007 Nanotechnology is not welcome in foods [1]
According to the German Federal Institute for Risk Assessment (BfR), the majority of consumers view the development of nanotechnology favourably. However, many are against the use of nanoparticles in food.

The majority are against the use of nanotechnology in food: 69 percent of the respondents reject the use of nanoadditives in spices to prevent them from becoming lumpy. 84 percent do not want any foods whose appearance has been rendered more appealing for longer through the use of nanoparticles.

[1] Federal Institute for Risk Assessment (BfR): The majority of consumers view the development of nanotechnology favourably. 19.12.2007.
http://www.bfr.bund.de/cd/10563

13.12.2007: Disagreement between epidemiological/ observational studies and randomised clinical trials [1]

                                                                 Observational study
In statistics the goal of an observational study is to draw inferences about the possible effect of a treatment on subjects, where the assignment of subjects into a treated group versus a control group is outside the control of the investigator. This is in contrast with controlled experiments, such as randomized controlled trials, where each subject is randomly assigned to a treated group or a control group before the start of the treatment.

A major challenge in conducting observational studies is to draw inferences that are acceptably free from influences by overt biases, as well as to assess the influence of potential hidden biases.
A bias is a prejudice in a general or specific sense, usually in the sense for having a preference to one particular point of view or ideological perspective. However, one is generally only said to be biased if one's powers of judgement are influenced by the biases one holds, to the extent that one's views could not be taken as being neutral or objective, but instead as subjective.

Observational studies serve a wide range of purposes, on a continuum from the discovery of new findings to the confirmation or refutation of previous finding. Some studies are essentially exploratory and raise interesting hypotheses. Others pursue clearly defined hypotheses in available data. In yet another type of studies, the collection of new data is planned carefully on the basis of an existing hypothesis. [2]

STROBE: In 2007, several prominent medical researchers issued the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement, in which they called for observational studies to conform to 22 criteria that would make their conclusions easier to understand and generalise. [2]  Download STROBE

                                                     Randomized controlled trial (RCT)
A randomized controlled trial (RCT) is a type of scientific experiment most commonly used in testing healthcare services. 'RCTs are considered the most reliable form of scientific evidence in healthcare because they eliminate spurious causality and bias'. RCTs are mainly used in clinical studies, but are also employed in other sectors such as judicial, educational, and social research. involve the random allocation of different interventions (or treatments) to subjects. This ensures that known and unknown confounding factors are evenly distributed between treatment groups.

Traditionally the control in randomized controlled trials refers to studying a group of treated patients not in isolation but in comparison to other groups of patients, the control groups, who by not receiving the treatment under study give investigators important clues to the effectiveness of the treatment, its side effects, and the parameters that modify these effects.

Open trial
In an open trial, the researcher knows the full details of the treatment, and so does the patient. These trials are open to challenge for bias, and they do nothing to reduce the placebo effect. However, sometimes they are unavoidable, particularly in relation to surgical techniques, where it may not be possible or ethical to hide from the patient which treatment he or she received. Usually this kind of study design is used in bioequivalence studies.

Blind trials
Single-blind trial
In a single-blind trial, the researcher knows the details of the treatment but the patient does not. Because the patient does not know which treatment is being administered (the new treatment or another treatment) there might be no placebo effect.

Double-blind trial
In a double bling trial, one researcher allocates a series of numbers to 'new treatment' or 'old treatment'. The second researcher is told the numbers, but not what they have been allocated to. Since the second researcher does not know, they cannot possibly tell the patient, directly or otherwise, and cannot give in to patient pressure to give them the new treatment. Therefore double-blind (or randomized) trials are preferred, as they tend to give the most accurate results.

Triple-blind trial
The most common meaning is that the subject, researcher and person administering the treatment are blinded to what is being given. Alternately, it may mean that the patient, researcher and statician are blinded.

Difficulties
A major difficulty in dealing with trial results comes from commercial, political and/or academic pressure. Most trials are expensive to run, and will be the result of significant previous research, which is itself not cheap. There may be a political issue at stake (compare or vested interests . In such cases there is great pressure to interpret results in a way which suits the viewer, and great care must be taken by researchers to maintain emphasis on clinical facts.

 The Tatsioni analysis on disagreements between epidemiological/ observational studies and           
                                                                  randomised clinical trials [3]
Athina Tatsioni and colleagues evaluated the citations for two highly cited observational studies for cardiovascular benefits associated with vitamin E supplementation and publications related to the protective effects of beta-carotene on cancer and estrogen on Alzheimer’s disease They looked for an explanation how these benefits continue to be defended in literature, despite contradicting evidence from large RCTs.

In this trial despite the eventual accumulation of strongly refuting evidence, even in 2005, half of the articles citing these epidemiological studies were still favourable to the vitamin E claim.

The same situation was observed for beta-carotene, said the authors. "In 2006 more than half of the articles citing the highly cited epidemiologic articles on beta-carotene for cancer prevention remained favourable for these interventions.

The authors concluded that Claims from highly cited observational studies persist and continue to be supported in the medical literature despite strong contradictory evidence from randomized trials. According to the authors differential interpretation, inappropriate entrenchment of old information, lack of dissemination of newer data, or purposeful silencing of their existence is to be blamed for this situation

                Controversity of results between observational and randomized clinical trials [4]
According to Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, Council for Responsible Nutrition research may seem to contradict itself, however, that should not be interpreted to mean one type of study trumps another, particularly when different studies ask and answer different questions. Seemingly conflicting data can exist side by side, when one understands that not all studies are asking the same questions in the same populations.

Dr. Shao says “this suggests that researchers interpret research differently, depending on their bias and expertise. For pure scientific purposes, here’s a valid hypothesis to test: conduct a trial on secondary prevention in heart patients with a lifetime of bad habits that likely contributed to their heart disease to determine if a nutrient might provide some benefit. But it’s not valid to conclude from the results of that study that the nutrient doesn’t work. We can’t expect a simple vitamin supplement to reverse heart disease. So if that doesn’t happen, we must interpret the results appropriately by placing the study in the proper context and acknowledge that the results don’t answer the question of whether supplemental amounts of vitamin E in a healthy population could have prevented heart disease had it been used consistently over time in combination with other antioxidants.”

Dr. Shao states, “The Randomized Clinical Trials RCTs with negative results attempted to answer the question, ‘can a supplemental nutrient treat or reverse a disease or a lifetime of unhealthy habits in patients who are also taking prescription medications?’.

The observational studies with positive results attempted to answer the question, ‘if we start with a mostly healthy population generally free of disease, can we identify various diet/nutrient and lifestyle factors that make them more or less prone to disease?’

These are very different questions, making the studies incompatible for direct comparison and demonstrating that one type of study can’t necessarily be used to refute the other. We firmly believe that RCTs should not be thought of as the only rigorous research approach. As the study authors point out, ‘when randomized and observational studies disagree, it is incorrect to assume that nonrandomized studies are always wrong.’ Rather, we should put studies into the appropriate context and evaluate the total body of evidence, which includes RCTs and observational studies, and other types of research.


[1] Wikipedia: Observational study
http://en.wikipedia.org/wiki/Observational_studies

[2] von Elm, Erik; Altman, Douglas G.; Egger, Matthias; Pocock,; Gøtzsche, Peter C.; Vandenbroucke, Jan P.: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies. PLoS Med. 4 (10): e296. Doi:10137/journal.pmed.0040296. PMID 17941714.
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040296
&ct=1&SESSID=ab3b8afe946778451b6162da4f8e1d3d

[3]Tatsioni, Athina; Bonitsis, Nikolaos G.; Ioannidis, John P. A.: Persistence of Contradicted Claims in the Literature. JAMA. 5. December 2007;298(21):2517-2526.
http://jama.ama-assn.org/cgi/content/abstract/298/21/2517

[4] Council for Responsible Nutrition: New JAMA Study Raises Issue of How Nutrients Should be Researched. Press Room Washington D.C., December 4, 2007
http://www.crnusa.org/PR07_JAMAstudy071203.html


12.12.2007: Fortification of dairy products with magnesium [1]
According to Maud Cansell and colleagues about 20 per cent of the French population present a magnesium deficiency. Undersupply of this mineral has been linked to high blood pressure, cardiovascular diseases, muscular weakness, and diarrhoea.

The authors studied the supplementation of magnesium in foods like dairy products. Magnesium can induce in these foods chemical degradations, protein aggregation and generate an unpleasant taste. To avoid this the researchers created a blend of rapeseed oil, olive oil, olein, and/or miglyol.

 Polyglycerol polyricinoleate and sodium caseinate which traps the magnesium in the interior of a Water/Oil/Water emulsion. The unwanted reactions are avoided, and magnesium is released from the W/O/W emulsion by hydrolysis of the oil in the intestine. The emulsion is stable during pasteurisation.

[1] Bonnet, M.; Cansell, M.; Berkaoui, A.; Ropers, ; Anton, M. Leal-Calderon, F. : Release rate profiles of magnesium from multiple W/O/W emulsions. Food Hydrocolloids (Elsevier) Published on-line ahead of print 5 December 2007, doi:10.1016/j.foodhyd.2007.11.016


11.12.2007: Flavonoids, such as isoflavones, anthocyanidins and flavonols
Phytoestrogens are substances which are estrogen-like. They are sometimes called endocrine disrupters. Some hypothesis say that exogenous substances with estrogenic or other hormonally
active properties may adversely affect human health. [1]

Endocrine disruptors can be industrial contaminants, such as pesticides and plasticizers, and others are natural phytoestrogens found in plants such as soy and in herbal supplements.

They may cause male wild-life animals in water contaminated by detergent, polychlorinated biphenyls (PCBs) and herbicide to express female characteristics and other modifications . Human development can also be feminized by exposure to estrogenic chemicals, affect breast growth and lactation, and could have a role in uterine diseases such as fibroids and endometriosis.
Endocrine-disrupting chemicals mostly exhibit estrogenic effects, but a few are anti-estrogenic or anti-androgenic, resulting in reduced fertility in breeding cattle. [2]

They are found in plants. Important phytoestrogens are ligans, isoflavones and coumetans.

Lignans: They are found in flax seed (300 mg/100g), sesame seed (290 mg/100g), brassica vegetables (0,2 - 2 mg/100 g), red wine (0,09 mg/100 g). When part of the human diet, some lignans are metabolized to form mammalian lignans known as enterediol and enterolactone by intestinal bacteria. Lignans that can be metabolised to form mammalian lignans are pinoresinol, lariciresinol, secoisolariciresinol, matairesinol, hydroxymatairesinol, syringaresinol and sesamin. [3]

Isoflavones: Isoflavones are polyphenolic compounds produced almost exclusively by the members of the Fabaceae/ Leguminosae (bean) family. Important isoflavones are genistein, daidzein, glycitein and formononetin. Soy products contain the highest amounts of isoflavone, followed by legumes, meat products and other processed foods, cereals and breads, nuts and oilseeds, vegetables, alcoholic beverages, fruits, and non alcoholic beverages. [4]

Coumetans: A known coumestan is the coumestrol. Coumestans are estrogen-like substances (phytoestrogens) made by some plants. Coumestans may have anticancer effects according to the U.S. National Cancer Institute.
A new coumestan, tephcalostan has been isolated from the whole plant of Tephrosia calophylla BEDD. together with two known flavonoids. [5]

Flavonoids, lignans and reduction of risk of breath cancer [6]
Bryan Fink and colleagues investigated the association of dietary flavonoid intake with reduced risk of breast cancer in a population-based sample of US women. The authors found a decrease in breast cancer risk associated with flavonoid intake, most pronounced for flavonols, flavones, flavan-3-ols, and lignans in postmenopausal women.
The authors conclude that women consuming sufficient levels of flavonoids may benefit from their potential chemopreventive effects. Flavonoids antioxidants may thus reduce mortality among postmenopausal in breast cancer patients.

Brian Fink from the University of North Carolina states, write in another publication, that his team found that the breath-cancer mortality in postmenopausal women may be reduced in association with high levels of dietary flavones and isoflavones. No reduction of risk was found in premenopausal women.

Flavonoids and flavanones reduce oral and paryngeal cancer [8]
The intake of flavonoids has been inversely related to the risk of various common neoplasms, but scanty data exist on oral and pharyngeal cancer. We have applied data on food and beverage content of six major classes of flavonoids. for flavanones, for flavonols, and for total flavonoids. No significant association emerged for isoflavones, anthocyanidins, flavan-3-ols, and flavones. The inverse relations with total flavonoids and flavanones was significant, whereas that with flavonols were nonsignificant. None of the associations were significant after further allowance for vitamin C, probably on account of the high collinearity between these compounds.

[1] Juberg, Daland R.: An Evaluation of Endocrine Modulators: Implications for Human Health. Ecotoxicology and Environmental Safety. Volume 45, Issue 2, February 2000, Pages 93-105. Doi:10.1006/eesa.1999.1851.

[2] McLachlan, John A.; Weatherhead, Erica Simpson; Melvenia Martin: Endocrine disrupters and female reproductive health. Best Practice & Research Clinical Endocrinology & Metabolism. Volume 20, issue1, March 2006, Pages 63-75. Doi: 10.1016/j.beem.2005.09.003

[3] Thompson LU, Boucher BA, Liu Z, Cotterchio M, Kreiger N. Phytoestrogen content of foods consumed in Canada, including isoflavones, lignans, and coumestan. Nutr Cancer 2006; [cited 2007 1 Mar];54(2):184-201.
http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16898863

[4] Horn-Ross, P.L.; Barnes, S.; Lee, M.; Coward, L.; Mandel, J.E.; Koo J.; John, E.M.; Smith, M.: Assessing phytoestrogen exposure in epidemiologic studies: development of a database (United States). Cancer Causes Control 2000 Apr;11(4):289-98.
http://www.springerlink.com/content/c1wx00ufqkwl/?p=e92cfdd557f64fa18e33b29ba2eb81de&pi=77

[5] Pennaka Hari Kishore, Mopuru Vijaya Bhaskar Reddy, Duvvuru Gunasekar, Madugula Marthanda Murthy, Cristelle Caux and Bernard Bodo, “A New Coumestan from Tephrosia calophylla”, Chem. Pharm. Bull., Vol. 51, 194-196 (2003). doi:10.1248/cpb.51.194
http://www.jstage.jst.go.jp/article/cpb/51/2/51_194/_article/-char/en

[6] Fink, Brian N.;  Steck, Susan E.;  Wolff, Mary S.;   Britton, Julie A.;  Kabat, Geoffrey C.;  Schroeder, Jane C.; Teitelbaum, Susan L.; Neugut, Alfred I.; Gammon, Marilie D. : Dietary Flavonoid Intake and Breast Cancer Risk among Women on Long Island. Am. J. Epidemiol. March 2007 165: 514-523; doi:10.1093/aje/kwk033
http://aje.oxfordjournals.org/cgi/content/abstract/165/5/514

[7]   Fink, B.N.;  Steck, S.E.;  Wolff, M.S.; Britton, J.A.;  Kabat, G.C.;  Gaudet, M.M.; Abrahamson, P.E.;  Bell, P.; Schroeder,