Gut, Grain and Greens (3G): The Effect of Wholegrain on Gut Microbiome and Metabolic Health
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Metagenomic profile
研究概览
简要总结
Objective: To identify how specific changes of the whole grain 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 intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.
Intervention: low vs. high whole grain 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 diet rich in whole grain in the active treatment period and a refined grain diet during the control period.
Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Investigator)
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
- •Body mass index (BMI): 25 - 35 kg/m2
- •No medical prescribed diet
- •Weight stable
- •No blood donation during the study
- •Intense sporting activities less than 10h/ week
- •Alcohol consumption less than 14 units/ week (female) and 21 units/ week (male)
- •Signed written consent
排除标准
- •Pharmacological treatment; hypertension, 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
- •Intake of vitamin, mineral, or pre- or probiotic supplements for 1 month prior to study start
- •Blood hemoglobin < 7.0 mmol/l
- •Blood donation within 1 month prior to study start
结局指标
主要结局
Metagenomic profile
时间窗: At the end of the intervention periods
Altered quantitative metagenomics at bacterial gene- and species levels, which is a non-specific outcome, but included as the main hypothesis of the project is to test if HOMA-IR is affected via changes in the gut microbiome.
HOMA-IR
时间窗: At the end of the intervention periods
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
次要结局
- Appetite hormones(At the end of the intervention periods)
- Body composition(At the end of the intervention periods)
- Subjective appetite sensation(At the end of the intervention periods)
- Energy intake(At the end of the intervention periods)
- Immune markers(At the end of the intervention periods)
- Markers of one-carbon metabolism(At the end of the intervention periods)
- Colonic fermentation(At the end of the intervention periods)
- Gene expression(At the end of the intervention periods)
- Gastrointestinal permeability, Lactulose/ mannitol ratio(At the end of the intervention periods)
- Blood pressure(At the end of the intervention periods)
- Blood lipid profile(At the end of the interventions periods)
- Immune cell profiling(At the end of the intervention periods)
- Markers og glucose hemostasis(At the end of the intervention periods)
- Mean intestinal transit time(At the end of the intervention periods)
- Blood immune cell content(At the end of the intervention periods)
- Plasma adipokines(December 2015)
- Saliva microbial flora(At the end of the intervention periods)
- Ex vivo cytokine production(At the end of the intervention periods)
研究者
Arne Astrup
Professor
University of Copenhagen