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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Markers; Intestinal Microbiota
• Intervention / Treatment: Dietary supplement: low meat high fibre; Dietary supplement: high meat low fibre

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: Umeå University; VTT Technical Research Centre of Finland; Quadram Institute Bioscience
• Investigators: Principal Investigator: Jana Foerster, PhD student, German Institute of Human Nutrition Potsdam-Rehbruecke

Publications and helpful links

General Publications

• Foerster J, Maskarinec G, Reichardt N, Tett A, Narbad A, Blaut M, Boeing H. The influence of whole grain products and red meat on intestinal microbiota composition in normal weight adults: a randomized crossover intervention trial. PLoS One. 2014 Oct 9;9(10):e109606. doi: 10.1371/journal.pone.0109606. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 7, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: microbiota; dietary intervention; fibre; cross over; red meat
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: KBBE-2007-2-2-07_WP2.4