TORNADO: Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

Sponsor

German Institute of Human Nutrition (Other)

Overall Status

Completed

CT.gov ID

NCT01449383

Collaborator

Umeå University (Other), Quadram Institute Bioscience (Other), VTT Technical Research Centre of Finland (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Microbiota Blood Markers	Dietary Supplement: low meat high fibre Dietary Supplement: high meat low fibre	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: low meat high fibre (lmhf)

consumption of less than 30g red meat per day and at least 40g dietary fibre per day

Dietary Supplement: low meat high fibre

less than 30g red meat and at least 40g dietary fibre per day

Active Comparator: high meat low fibre (hmlf)

consumption of 200g red meat and not more than 20g dietary fibre per day

Dietary Supplement: high meat low fibre

at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day

Outcome Measures

Primary Outcome Measures

change in gut microbiota composition [baseline, week 3, 6 and 9]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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