跳至主要内容
临床试验/NCT02351297
NCT02351297已完成不适用

Effects of High Protein Diet on the Large Intestine in Overweight Humans

Hospital Avicenne0 个研究点目标入组 42 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
主要终点
Change in gene expression in rectal biopsy from baseline after 3 week dietary intervention

研究概览

简要总结

This study aims at evaluating the consequences of a 3 weeks high protein diet on the large intestine ecosystem (microbiota, metabolites and gene expression in rectal mucosa). Those parameters will be analysed with technics including OMICs methods. After a run-in period, 42 volunteers will receive either soy or milk protein or maltodextrin as a placebo control. This trial is double blind randomized placebo-controlled paralleled design (3 arms). Longitudinal sampling will allow the comparison of parameters during the study.

详细描述

High protein diets are widely used for their slimming effect. Those diets increase the quantity of undigested protein and peptides reaching the large intestine. Microbiota utilizes protein and peptides as substrates and produces amino-acid derived metabolites such as short chain fatty acids, branched chain fatty acids, lactate, formate, succinate, ammonium, hydrogen sulfide and phenolic compounds. Some of those metabolites have been shown to be beneficial to the host whereas other could be deleterious. High protein diets may have different effects whether based on animal or plant proteins since those two kinds of protein have different amino acids composition and slightly different digestibility. The objective of this study is to evaluate in overweight volunteers the consequences of high protein diets (animal vs vegetal) vs isocaloric-normoproteic diet at the level of the large intestine and metabolism. Firstly, composition and activity of the microbiota and the metabolites produced in the large intestine lumen will be determined. Then, to evaluate the consequences of the tested diets on mucosal physiology, gene expression will be analyzed in rectal biopsies and fecal water will be tested on colonocytes cell lines. Lastly, the consequences of the diets on host metabolism will be evaluated.

Dietary intervention

Before the study, volunteers (n=42) will provide a 3 day food record that will be utilized by a dietician to calculate their usual energy intake. The study will start with a 2 weeks normalization period during which the volunteers will have to eat according to menus (Fig. 1). The diet will provide to the volunteer their usual individual energy intake; and protein, carbohydrates and fat will respectively provide 15, 50 and 35 % of the energy intake.

At the end of this standardization period, volunteers will be randomly assigned into 3 groups (n=14) for 3 weeks (intervention period) (Fig. 1). Volunteers of the 3 groups will follow a diet with a reduced digestible carbohydrates intake (15% of energy intake) while undigestible carbohydrate intake will remain unchanged. The volunteers will consume 3 times per day a dietary supplement powder that they will dissolve in water and then drink. This supplement will provide them 15% of their energy intake. The first group will receive a casein (animal protein) supplement so that they will have a high protein diet (protein, carbohydrates and fat will respectively provide 30, 35 and 35 % of the energy intake). The second group will receive a soy protein(vegetal) supplement so that they will also consume a high protein diet (protein, carbohydrates and fat will respectively provide 30, 35 and 35 % of the energy intake). The third group will receive a maltodextrin (digestible carbohydrate, placebo control) supplement so that they will ingest a normoproteic diet, similar in macronutrient composition to the standardization diet (protein, carbohydrates and fat will respectively provide 15, 50 and 35 % of the energy intake). The dietary supplement will be given in a double-blinded protocol. There will be no energy restriction between the standaridization and intervention periods.

Clinical protocol

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 25- 30
  • Body weight stable last 3 months
  • Moderate physical activity

排除标准

  • Abnormal food behavior
  • Digestive, renal, hepatic, pulmonary, hemostasis, neoplasic diseases
  • antibiotic, pre or probiotics use in the last 3 months
  • intolerance for the tested product
  • positive serology for infectious disease
  • pregnancy

结局指标

主要结局

Change in gene expression in rectal biopsy from baseline after 3 week dietary intervention

时间窗: Change for baseline in gene expression in rectal biopsy after 3 weeks dietary intervention

Gene expression in biopsies collected before (baseline) and after 3 week dietary intervention will be measured by transcriptomic analyses. Differential gene expression will be expressed as relative units (fold change).

次要结局

  • microbiota composition analysis(Change for baseline in microbiota composition after 3 weeks dietary intervention)
  • fecal water metabolomics(Change for baseline in fecal water metabolites after 3 weeks dietary intervention)

研究者

发起方
Hospital Avicenne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Benamouzig

Head of gastroenterology department

Hospital Avicenne

相似试验