Nutraveris
Monday, March 8, 2010
Category : CLAIMS, CONVICTIONS | Author : experts | Comment : No Comments
Tags: , , , , , , , , , ,

Of the three main points (characterization of the product, relevance of the claimed effect to human health, scientific substantiation of the claimed effect), this health claim file received a negative opinion because of insufficient scientific substantiation of the claimed effect.

The claimed effect is “appetite control”, and then the Panel assumes that the target population is individuals who need to control their energy intake. For EFSA, appetite control refers to satiety, understood as the decrease in motivation to eat after consumption of food, varies in magnitude and duration and may include only changes in appetite ratings (hunger, fullness, satiety, and desire to eat) or also a reduction in subsequent energy intake. The only pertinent study showed no significant differences in hunger, satiety or fullness between xanthane and placebo.

To obtain a positive opinion it remains to complete the current data with a clinical study providing evidence to support the satiating effect of xanthane, such a study we have started many years ago for another active.

All claims are accessible online on Nutraveris’on line

Monday, March 1, 2010
Category : CLAIMS, CONVICTIONS, CLINICAL EVIDENCE | Author : experts | Comment : No Comments
Tags: , , , , , , ,

This new review is interesting regarding the problematic of health claim because for its authors, results of calcium and vitamin D supplementation trials have been inconsistent, suggesting that reliance on this intervention may be inadequate for prevention of osteoporosis, while a positive opinion has been accepted for a Chewing tablets with calcium and vitamin D.

Indeed, for the NDA panel of EFSA, the following wordings reflect the scientific evidence: “Calcium may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures” and “Calcium and vitamin D may reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor in the development of osteoporotic bone fractures”.

Moreover, in addition to dairy, fruit and vegetable intake has emerged as an important modifiable protective factor for bone health. Several nutrients, including magnesium, potassium, vitamin C, vitamin K, several B vitamins, and carotenoids, have been shown to be more important than previously realized. Rather than having a negative effect on bone, protein intake appears to benefit bone status, particularly in older adults. Regular intake of cola beverages shows negative effects and moderate alcohol intake shows positive effects on bone, particularly in older women. Current research on diet and bone status supports encouragement of balanced diets with plenty of fruit and vegetables, adequate dairy and other protein foods, and limitation of foods with low nutrient density. Some of these actives have already a positive opinion on this application.

All claims are accessible online on Nutraveris’on line

Reference: Tucker KL. Osteoporosis prevention and nutrition. Curr Osteoporos Rep. 2009 Dec;7(4):111-7

A new application for a health claim has been filed under article 13.5 to EFSA by Kellogg for a slimming purpose. This claim relates to ready to eat breakfast cereals and deals with body weight, body fat, and waist circumference reduction. The EFSA’s Panel considers that the maintenance or achievement of a normal body weight is beneficial to human health, and that reduction of body fat may represent a beneficial effect for humans. However, the biologic relevance of the observed effects also has to be considered, and a transitory reduction in waist circumference of less than 1 cm is of limited biological relevance according to the Panel. To date, none of the submitted health claim dealing with weight management received a positive opinion from EFSA.

References : http://registerofquestions.efsa.europa.eu/roqFrontend/questionsListLoader?panel=ALL

As we expected, after having given negative opinion for Glucosamine and Chondroitin in the first batch of article 13.1 published in last October (see our older article), the EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has also mass rejected the other main ingredients used for joint health, such as Harpagophytum and Curcuma.

The NDA found:

  • Maintenance of normal joints is a beneficial physiological effect
  • No human studies investigating the effects of the food(s)/food constituent(s) on the maintenance of normal joints have been provided in relation to any of the health claims evaluated. Indeed, no scientific conclusions can be drawn for the substantiation of the claims from references on food(s)/food constituent(s) other than those for which the specific claims are proposed, and/or claimed effects unrelated to the structure and/or function of joints, and/or on the “antioxidant” or “anti-inflammatory” properties of food(s)/food constituent(s) used in certain countries in the management of medical conditions associated with acute or chronic joint damage of either inflammatory or degenerative origin (e.g. osteoarthritis, rheumatoid arthritis, psoriatic arthritis, arthritis of infectious origin).

Following the negative opinion on health claims submitted for joint, it will probably no longer be possible to communicate on such products which are the first global marketplace for food supplement in Europe!

Indeed, studies supporting the efficacy of glucosamine, chondroïtine, harpagophytum, curcuma or other on joint have mainly been performed in populations of patients for the management of medical conditions (osteoarthritis, rheumatoid arthritis, etc…). This target population cannot support scientific evidence in food supplements.

As we anticipated, expressed long time ago in an interview for nutraingredient (http://www.nutraingredients.com/Industry/Industry-split-on-glucosamine-health-claim-rejection) it is essential to prove the efficacy of a well characterized ingredient (glucosamine as other ingredients for joint) in healthy subjects in a golden standard designed study. Such important points we have experienced in running a clinical study started many months ago.

All claims are accessible online on Nutraveris’on line.

This review address the question of the beta-carotene, beneficial or dangerous (see our article), previously treated in this blog. New results (ATBC, CARET, the Antioxidant Polyp Prevention, E3N studies) confirm what it could be expected, the adverse effects of beta-carotene supplementation are correlated with the smoking status of the study participants.

This is not supplementation with beta-carotene but smoking that is harmful for smokers !

A number of epidemiological studies have reported associations of beta-carotene plasma levels or intake with decreased lung cancer risk. However, intervention studies in smokers have unexpectedly reported increased lung tumor rates after high, long-term, beta-carotene supplementation.

Authors concluded that human and animal studies have shown that specific circumstances, among them heavy smoking, seem to influence the effect of high beta-carotene intakes. In normal, healthy, nonsmoking populations, there is evidence of beneficial effects.

Reference: Goralczyk R. ss-Carotene and Lung Cancer in Smokers: Review of Hypotheses and Status of Research. Nutr Cancer. 2009 Nov;61(6):767-74