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

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ClinicalTrials.gov Identifier: NCT01449383
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : August 14, 2012
Sponsor:
Collaborators:
Umeå University
Quadram Institute
VTT Technical Research Centre of Finland
Information provided by (Responsible Party):
Jana Foerster, 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.

Condition or disease Intervention/treatment Phase
Intestinal Microbiota Blood Markers Dietary Supplement: low meat high fibre Dietary Supplement: high meat low fibre Not Applicable

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  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

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



Primary Outcome Measures :
  1. change in gut microbiota composition [ Time Frame: baseline, week 3, 6 and 9 ]

Secondary Outcome Measures :
  1. change in anthropometry [ Time Frame: 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

  2. change in blood markers [ Time Frame: baseline, week 3, 6 and 9 ]
    clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP

  3. change in salivary microbial composition [ Time Frame: baseline, week 3, 6 and 9 ]


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449383


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jana Foerster, Jana Foerster, PhD student, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT01449383     History of Changes
Other Study ID Numbers: KBBE-2007-2-2-07_WP2.4
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012

Keywords provided by Jana Foerster, German Institute of Human Nutrition:
cross over
dietary intervention
fibre
red meat
microbiota