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Past News Items - January 2011

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In the News

FDA Study to Measure Consumer Response to Nutrition Label Changes

NIST Releases Reference Materials for Vaccinium Berries

Green Tea Combined With Vitamin D May Offer Bone Protection

Study Links B Vitamins to Slowing Progression of Dementia


Released: 01/01/11

FDA Study to Measure Consumer Response to Nutrition Label Changes

The United States Food and Drug Administration (FDA) announced plans to study consumer reactions to format changes of the nutrition label displayed on food packaging.

The agency hopes to gain a better understanding of consumer comprehension of the nutrition label as part of its continuing efforts to enable consumers to make informed dietary choices and construct healthful diets. In specific, it is trying to determine if making the calorie count and serving size bigger or bolder or placing them in different positions will impact consumers’ ability to determine intake values and appropriate serving sizes.

The Code of Federal Regulations Title 21 101.9 defines a specific format for nutrition information labeling required on most packaged foods. The FDA’s Obesity Working Group released a plan in 2004 calling for changes to the format of this label in order to emphasize and clarify caloric information for consumers.

In response to the plan, the FDA issued 2 notices calling for comments on changes to the label: One addressed how greater emphasis could be given to the calorie content of the food and a second concerned amending serving size regulations.

The web-based study will randomly present consumers with nutrition labels from a set that varies by format, food product type, and nutritional quality, using a sample size of 10 000 participants. The tool will record consumer judgments related to nutritional attributes and overall healthfulness and their ability to use the label to calculate caloric intake and estimate serving size.

The results of the study will assist in determining whether modifications to the nutrition facts label can help consumers make informed choices.

The FDA notice can be found at Comments regarding the study can be sent to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer via e-mail at, or faxed to 202-395-7285. All comments should be identified with the OMB control number 0910—New, the title “Experimental Study of Nutrition Facts Label Formats,” and the FDA docket number [DOCID:fr17no10-98].

NIST Releases Reference Materials for Vaccinium Berries

Researchers from the National Institute of Standards and Technology (NIST) have developed new certified reference materials for measuring the amounts of organic acids in dietary supplements formulated with vaccinium berries(eg, cranberries, blueberries, and bilberries).

Seven Standard Reference Materials (SRM) products for vaccinium berries were created as part of an ongoing collaboration to develop dietary supplement SRMs. The collaboration is among NIST, the National Institutes of Health's Office of Dietary Supplements, and the FDA Center for Drug Evaluation and Research. The SRMs include: 1) Cranberry (Fruit), 2) Low-Calorie Cranberry Juice Cocktail, 3) Cranberry Extract, 4) Cranberry–Containing Solid Oral Dosage Form, 5) Mixed Berry–Containing Solid Oral Dosage Form, 6) Blueberry (Fruit), and 7) Bilberry Extract.

Dietary supplement manufacturers often include health claims on products made with vaccinium berries. Suggested benefits include prevention of urinary tract infections, reduced risk of certain cancers or Alzheimer's disease, and improved night vision.

A common problem with dietary supplement products containing berries is the risk of economic adulteration—dilution with less expensive fruits, such as apple or grape, or the use of blueberries instead of bilberries as a cost-saver for the manufacturer.

Analytical approaches for measuring organic acid ratios in berries, fruit juices, and dietary supplements have relied on the use of pure organic acid reference standards, which do not take into account the complexity of the whole berry. As a result, these methods could neither be validated as accurate nor used to certify reference materials to meet the needs and accuracy requirements of the FDA and dietary supplement manufacturers.

Through measurement of organic acid ratios, which are specific to each type of berry, these analytical standards can be achieved. The new matrix-matched certified references offer manufacturers and researchers a set of tools for quality assurance that had not previously existed.

More information on the NIST suite of vaccinium SRMs is available at

Green Tea Combined With Vitamin D May Offer Bone Protection

A study published recently in The Journal of Nutritional Biochemistry found that green tea polyphenols (GTP) and alfacalcidol (1-a-OH-vitamin D3, a hydroxylated form of vitamin D) offer protection for bone microstructure attacked by chronic inflammation. The study claims to be the first to “report a bone-protective benefit of GTP and 1-a-OH-vitamin D3 on bone microarchitecture” and suggests that the related reduction of bone erosion and increased bone formation are related to the combined supplements’ suppression of proinflammatorycytokine tumor necrosis factor-a (TNF-a).

In the 12-week study, researchers used lipopolysaccharides (LPS) to simulate a state of chronic inflammation in female rats to measure the effect of the 2 supplements—each alone and in combination. Furthermore, the study measured levels of TNF-a.

A 2 (no GTP vs 0.5% w/v GTP in drinking water) × 2 (no alfacalcidol vs 0.05 ?g/kg alfacalcidol orally, 5x/wk) factorial design was employed in 40 lipopolysaccharide (LPS)-administered female rats. A group of 10 rats receiving placebo administration was used to compare with a group receiving LPS administration only to evaluate the effect of LPS.

Upon data collection, researchers found that bone samples from the group of rats administered LPS only (ie, no supplements) showed expected bone microarchitecture deterioration and elevated levels of proinflammatory TNF-a when compared to the placebo group.

LPS-treated groups given either GTP through drinking water or alfacalcidol administered orally also showed expected results as demonstrated in previous studies cited by the authors—that is to say, less bone loss and lower levels of TNF-a as compared to the LPS-only group.

Particular to this study, results from the combined usage of the 2 supplements demonstrated enhanced bone mass values that exceeded any other test group, while at the same time improving the overall strength of the femoral bones relative to the LPS-only group. Although the strength results were similar for the GTP, alfacalcidol, and combined supplement groups, the overall benefits of enhanced bone mass values resulting from the supplements together were enough to merit their use in combination.

All 3 supplement groups showed evidence of “significantly down-regulated TNF-a expression,” which is consistent with other antioxidants in studies that measured against the same LPS inducement of chronic inflammation. According to the authors, this corroborates the role of the test supplements in skeletal health, which “may reduce the risk of osteoporosis.”

The full study, “Protective Actions of Green Tea Polyphenols and Alfacalcidol on Bone Microstructure in Female Rats With Chronic Inflammation” by Shen et al, is available online at

Study Links B Vitamins to Slowing Progression of Dementia

Homocysteine-lowering B vitamins slowed brain atrophy over a 2-year period in subjects with mild cognitive impairment, according to a recent study published by AD Smith et al in PLoS One, a journalby the Public Library of Science. While dietary administration of B vitamins has previously been shown to reduce homocysteine levels in plasma, this study sought to specifically explore whether lowering homocysteine levels would slow accelerated brain atrophy in subjects with mild cognitive impairment.

The study employed 217 individuals randomly assigned to 2 groups of equal size. One group was treated with oral tablets containing folic acid (0.8 mg/d), vitamin B12 (0.5 mg/d), and vitamin B6 (20 mg/d), the other was treated with placebo.

Findings by the authors show a direct correlation of elevated homocysteine levels to accelerated brain atrophy in elderly individuals. This is an important link, as previous studies show that accelerated brain atrophy is one of the most important indicators of risk for dementia and Alzheimer’s disease, in particular. Furthermore, the study revealed that atrophy can be slowed significantly by reducing homocysteine levels through dietary B-vitamin supplementation. Oral B-vitamin treatment showed a 31.7% reduction in plasma homocysteine levels compared to placebo. This was accompanied by a reduction in the brain atrophy rate of nearly 30%. The study also found no safety issues related to the treatment.

The strongest responses were measured in individuals with the highest baseline homocysteine levels, achieving a 53% reduction of atrophy rate in the top quartile. Conversely, individuals with baseline levels in the bottom quartile showed no effect from the treatment.

Although the study did not directly explore the effects of treatment on cognitive test scores, the authors used existing studies of B-vitamin effects on cognition and the progression of Alzheimer’s disease to extrapolate the expected benefits of linking reduced homocysteine levels to cognitive outcomes.
The complete study can be found at (

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