Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

Not Applicable

Completed

• Conditions: Intestinal Microbiota; Blood Markers
• Interventions: Dietary Supplement: low meat high fibre; Dietary Supplement: high meat low fibre

• Registration Number: NCT01449383
• Lead Sponsor: German Institute of Human Nutrition

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-13
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
low meat high fibre (lmhf)	low meat high fibre	consumption of less than 30g red meat per day and at least 40g dietary fibre per day
high meat low fibre (hmlf)	high meat low fibre	consumption of 200g red meat and not more than 20g dietary fibre per day

Primary Outcome Measures

Name	Time	Method
change in gut microbiota composition	baseline, week 3, 6 and 9

Secondary Outcome Measures

Name	Time	Method
change in anthropometry	baseline, week 3, 6 and 9	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
change in blood markers	baseline, week 3, 6 and 9	clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP
change in salivary microbial composition	baseline, week 3, 6 and 9