Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods.

There is substantial evidence to link what we eat to the reduction of the risk of major chronic diseases and/or the improvement of functions. Thus, it is important for public health agencies and the food industry to facilitate the consumption of foods with particular health benefits by providing consumer products and messages based on scientific evidence. Although fragmentary advice is available from a range of sources, there is a lack of comprehensive scientific guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Such guidelines are needed both to support nutrition science in general, and to facilitate the substantiation of health claims. In the present study, which presents the consensus view of an International Life Sciences Institute Europe Expert Group that included senior scientists from academia and industry, the term 'foods' refers to foods, dietary supplements and food constituents, but not to whole diets. The present study is based on an initial survey of published papers, which identified the range and strengths and weaknesses of current methodologies, and was finalised following exchanges between representatives from industry, academia and regulatory bodies. The major factors involved in the design, conduct and reporting of studies are identified, summarised in a checklist table that is based on the Consolidated Standards of Reporting Trials guidelines, and elaborated and discussed in the text.

Vitamin and mineral inadequacy in the French population: estimation and application for the optimization of food fortification.

The objective was to assess the prevalence of inadequate micronutrient intake in a representative sample of the French population, which to our knowledge, had never been done before, and to use this concept to optimize efficiency and safety of food fortification. The INCA survey collected food intake data using a 7-day record, for 2373 subjects (4-92 years). The prevalence of inadequacy for calcium, magnesium, iron, vitamins C, A, B6, and B12, thiamin, riboflavin, niacin, pantothenic acid, and folate was estimated by the proportion of subjects with intake below the Estimated Average Requirement (EAR). We also calculated daily consumption of 44 food groups by age and gender. This paper shows how the combination of both data sets, i.e., inadequacy and food consumption data, allows a preliminary screening of potential food vehicles in order to optimize fortification. The prevalence of inadequacy was particularly high for the following groups: for calcium, females aged 10-19 years (73.5%) or aged 55-90 years (67.8%), and males aged 15-19 years (62.4%) or aged 65-92 years (65.4%); for magnesium, males aged 15-92 years (71.7%) and females aged 10-90 years (82.5%); for iron, females aged 15-54 years (71.1%); and for vitamin C, females aged 15-54 years (66.2%). Two examples are provided to illustrate the proposed method for the optimization of fortification.

[Dietary fat consumption of the French population and quality of the data on the composition of the major food groups]. / Consommation lipidique de la population française et qualité des données de composition des principaux groupes d'aliments vecteurs.

The validity of estimated association between dietary fat intake and cancer depends both on the methodology of dietary assessment used and on the quality of food composition data. The food composition database of Afssa/Ciqual shows that there is a deficiency in data on fatty acids. In order to identify the priorities for improving the quality of the database, we analysed the data quality of major dietary contributors of fatty acids in the French population. These food contributors, listed according to their contribution to fat intake, have been identified by French national consumption survey Inca. Consumption studies in France show a high dietary fat contribution (37-38% even 40% of total energy) with over-consumption of saturated fatty acids, under-consumption of monounsaturated fat and, to a lesser extent of polyunsaturated fatty acids. Major food contributors of total fat and saturated fatty acids are butter, cheese, meat products, meats, dishes, dressing, cakes and pastry and, only in children, biscuits. Among contributors of monounsaturated fatty acids, vegetable oils and sauces are listed after processed meats before meats, butter, cheese and dishes. Vegetable oils and sauces are the major contributors of polyunsaturated fatty acids before "fatty" potatoes (such as chips...) in adults whereas the opposite was observed in children. Composition tables do not presently allow the identification of contributors of specific fatty acids (omega 3, omega 6, conjugated linoleic acid). If nutritional data of milk products, fats, and oils are reliable because of existing specific tables for these products, there is a need for improving quality of composition data for other major contributors such as: meats, processed meats, fish and dishes such as pizzas, pasteries...

Complications after laparoscopic adjustable gastric banding for morbid obesity: experience with 1,000 patients over 7 years.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is considered the least invasive surgical option for morbid obesity. It is less efficient than gastric bypass in weight loss, but has the advantage of being potentially reversible and can improve the quality of life if mortality and morbidity are low. METHODS: Between 1996 and 2003, 1,000 patients underwent LAGB. There were 896 women and 104 men with mean age 40.4 years (16.3-66.3). Preoperative mean BMI was 44.3 kg/m(2). RESULTS: There were no deaths. Cumulative rate of complications was 192 (19.2%). 12 were life-threatening (1.2%): gastric perforation (n=4), acute respiratory distress (n=2), pulmonary embolism (n=2), migration (n=3), and gastric necrosis (n=1). 111 patients required an abdominal reoperation (11.1%) for perforation (n=2), slippage (n=78), migration (n=3), necrosis (n=1), esophageal dilatation (n=2), incisional hernias (n=4) and port problems (n=21). Before October 2000, we used the perigastric technique, and the slippage rate was 24% (91 / 378 ).Then, we changed to the pars flaccida approach and the slippage rate fell to 2% (13 / 622). The pars flaccida approach demonstrated safety in relation to both risks of perforation and slippage. CONCLUSION: The cumulative complication rate increased to 3-4 years, and then decreased with experience and technical improvement. Concerns of long-term follow-up should be migration and esophageal dilatation, which seem to be rare at 3 years.

Laparoscopic gastric banding: a minimally invasive surgical treatment for morbid obesity: prospective study of 500 consecutive patients.

OBJECTIVE: To evaluate early and late morbidity of laparoscopic adjustable gastric banding for morbid obesity and to assess the efficacy of this procedure by analyzing its results. SUMMARY BACKGROUND DATA: Laparoscopic adjustable gastric banding is considered the least invasive surgical option for morbid obesity. It is effective, with an average loss of 50% of excessive weight after 2 years of follow-up. It is potentially reversible and safe; major morbidity is low and there is no mortality. METHODS: Between April 1997 and June 2001, 500 patients underwent laparoscopic surgery for morbid obesity with application of an adjustable gastric band. There were 438 women and 62 men (sex ratio = 0.14) with a mean age of 40.4 years. Preoperative mean body weight was 120.7 kg and mean body mass index (BMI) was 44.3 kg. m. RESULTS: Mean operative time was 105 minutes, 84 minutes during the last 300 operations. Mean hospital stay was 4.5 days. There were no deaths. There were 12 conversions (2.4%), 2 during the last 300 operations. Fifty-two patients (10.4%) had complications requiring an abdominal reoperation. Forty-nine underwent a reoperation for minor complications: slippage (n = 43, incisional hernias (n = 3), and reconnection of the catheter (n = 3). Three patients underwent a reoperation for major complications: gastroesophageal perforation (n = 2) and gastric necrosis (n = 1). Seven patients had pulmonary complications and 36 patients experienced minor problems related to the access port. At 1-, 2-, and 3-year follow-up, mean BMI decreased from 44.3 kg. m to 34.2, 32.8, and 31.9, respectively, and mean excess weight loss reached 42.8%, 52%, and 54.8%. CONCLUSIONS: Laparoscopic adjustable gastric banding is a beneficial operation in terms of excessive weight loss, with an acceptably low complication rate. It can noticeably improve the quality of life in obese patients. Half of the excess body weight can be effortlessly lost within 2 years.