Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

Study Overview
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Brief Summary
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This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.

Detailed Description
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Human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. Due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. Examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.

Official Title
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Molecular Targets Open for Regulation by the Gut Flora - New Avenues for Improved Diet to Optimize European Health (TORANDO): WP2 Individual Intervention Studies- Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

Conditions
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Intestinal Microbiota, Blood Markers

Intervention / Treatment
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* Dietary Supplement: low meat high fibre
* Dietary Supplement: high meat low fibre


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 20 to 60 obtained informed consent willing and able to consume defined diets willing and able to collect all intended samples Exclusion Criteria: prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer Antibiotic treatment within the last three month before start of studies Prevalent gastrointestinal diseases, disorders and surgeries Pregnancy and breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low meat high fibre (lmhf)<br>consumption of less than 30g red meat per day and at least 40g dietary fibre per day | Dietary Supplement: low meat high fibre<br>* less than 30g red meat and at least 40g dietary fibre per day<br>|
| Active Comparator: high meat low fibre (hmlf)<br>consumption of 200g red meat and not more than 20g dietary fibre per day | Dietary Supplement: high meat low fibre<br>* at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in gut microbiota composition |  | baseline, week 3, 6 and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in anthropometry | Body height, body weight, circumferences of waist, hip, upper arm and leg, lower leg and the thickness of body folds at waist, back, upper arm and leg, lower leg and thorax depth and width | baseline, week 3, 6 and 9 | 
| change in blood markers | clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP | baseline, week 3, 6 and 9 | 
| change in salivary microbial composition |  | baseline, week 3, 6 and 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cross over, dietary intervention, fibre, red meat, microbiota