Gut, Grain and Greens (3G): The Effect of Gluten on Gut Microbiome and Metabolic Health.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Altered quantitative metagenomics at bacterial gene- and species levels.
研究概览
简要总结
Objective: To identify how specific changes of the gluten content in the diet affect the host-gut microbiome interactions with implications for metabolic health.
Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included.
Intervention: low vs high gluten intake.
详细描述
The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a gluten-poor diet (<5 g/d) in the active treatment period and a gluten-rich diet (>25 g/d) during the control period.
Measurements: Altered quantitative metagenomics at bacterial gene- and species levels is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, circulating appetite hormone levels,serum metabolomics, gastrointestinal transit time and intestinal permeability. Furthermore, selected control measures are included; 4-day food records and a study intervention dietary records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •, compulsory:
- •Body mass index (BMI): 25 - 35 kg/m2 OR
- •Abdominal obesity: waist circumference: men: ≥ 94cm; women: ≥ 80cm
- •No medically prescribed diet
- •Weight stable
- •Intense sporting activities less than 10 h/week
- •Alcohol consumption less than 14 units/week (female) and 21 units/week (male)
- •Signed informed consent
- •Inclusion criteria, minimum one of the following:
- •Fasting plasma glucose from 6.1 mmol/l to 6.9 mmol/l
- •Reduced high density lipoprotein (HDL) cholesterol; HDL ≤ 1.03 mmol/L for men and ≤ 1.29 mmol/L for women
- •Increased triglyceride (TG) > 1.3 mmol/L
- •Systolic blood pressure > 130 mmHg
排除标准
- •Pharmacological treatment; diabetes and blood lipid regulation
- •Lactating (or lactating, 6 weeks ago), pregnant (or pregnant, 3 months ago) or wish to become pregnant during the study
- •Participation in another biomedical trial 1 month prior to study start
- •Diagnosed with any form of diabetes, celiac disease or chronic pancreatitis
- •Reported chronic gastrointestinal disorders
- •Antibiotic treatment for 3 month prior to study start
- •Blood hemoglobin < 7.0 mmol/l
- •Blood donation within 1 month prior to study start
研究组 & 干预措施
Low gluten
Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
干预措施: Low gluten (Other)
High gluten
Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
干预措施: High gluten (Other)
结局指标
主要结局
Altered quantitative metagenomics at bacterial gene- and species levels.
时间窗: Up to 3 years.
Feces samples are collected according to standard operation procedures for subsequent standardized microbial DNA extraction. Microbial DNA will be subjected to sequencing, microbial gene analyses, taxonomy analyses including enterotypes known species and unknown meta-species and functional annotation.
次要结局
- Colonic fermentation(Up to 2 years.)
- Mean intestinal transit time(Up to 2 years.)
- Gastrointestinal permeability.(Up to 2 years.)
- Blood pressure and pulse.(Up to 1 year.)
- Saliva microbial flora(Up to 2 years.)
- Nasal fluid(Up to 3 years.)
- Appetite hormones(Up to 3 years.)
- Celiac disease markers(Up to 1 year.)
- Blood lipid profile(Up to 2 years.)
- Bioimpedance(Up to 1 year.)
- Breath hydrogen.(Up to 2 years.)
- Insulin(Up to 2 years.)
- Glucose(Up to 2 years.)
- C-peptide(Up to 2 years.)
- Inflammatory makers(Up to 3 years.)
- Anthropometric characteristics.(Up to 1 year.)
研究者
Oluf Borbye Pedersen
Scientific Director, professor
University of Copenhagen