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
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 5, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 14, 2012
August 1, 2012
1.8 years
October 5, 2011
August 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in gut microbiota composition
baseline, week 3, 6 and 9
Secondary Outcomes (3)
change in anthropometry
baseline, week 3, 6 and 9
change in blood markers
baseline, week 3, 6 and 9
change in salivary microbial composition
baseline, week 3, 6 and 9
Study Arms (2)
low meat high fibre (lmhf)
ACTIVE COMPARATORconsumption of less than 30g red meat per day and at least 40g dietary fibre per day
high meat low fibre (hmlf)
ACTIVE COMPARATORconsumption of 200g red meat and not more than 20g dietary fibre per day
Interventions
less than 30g red meat and at least 40g dietary fibre per day
at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day
Eligibility Criteria
You may qualify if:
- age 20 to 60
- obtained informed consent
- willing and able to consume defined diets
- willing and able to collect all intended samples
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Institute of Human Nutritionlead
- Umeå Universitycollaborator
- Quadram Institute Biosciencecollaborator
- VTT Technical Research Centre of Finlandcollaborator
Related Publications (1)
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.
PMID: 25299601DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jana Foerster, PhD student
German Institute of Human Nutrition Potsdam-Rehbruecke
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jana Foerster, PhD student
Study Record Dates
First Submitted
October 5, 2011
First Posted
October 10, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 14, 2012
Record last verified: 2012-08