Clinical trial NCT01449383: Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Microbiota
Blood Markers
Keywords: cross over
dietary intervention
fibre
red meat
microbiota
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Quadram Institute Bioscience
name: VTT Technical Research Centre of Finland
First posted: 2011-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in gut microbiota composition
timeFrame: baseline, week 3, 6 and 9
Secondary outcomes:
measure: change in anthropometry
timeFrame: baseline, week 3, 6 and 9
measure: change in blood markers
timeFrame: baseline, week 3, 6 and 9
measure: change in salivary microbial composition
timeFrame: baseline, week 3, 6 and 9
Other outcomes:
Locations:
Study officials:
affiliation: German Institute of Human Nutrition Potsdam-Rehbruecke
name: Jana Foerster, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.