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

This study has been completed.
Sponsor:
Collaborators:
Umeå University
Institute of Food Research
VTT Technical Research Centre of Finland
Information provided by (Responsible Party):
Jana Foerster, German Institute of Human Nutrition
ClinicalTrials.gov Identifier:
NCT01449383
First received: October 5, 2011
Last updated: August 13, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Intestinal Microbiota
Blood Markers
 Dietary Supplement: low meat high fibre
Dietary Supplement: high meat low fibre

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Institute of Human Nutrition:

Primary Outcome Measures:
  • change in gut microbiota composition [ Time Frame: baseline, week 3, 6 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in anthropometry [ Time Frame: baseline, week 3, 6 and 9 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, week 3, 6 and 9 ] [ Designated as safety issue: No ]
    clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP

  • change in salivary microbial composition [ Time Frame: baseline, week 3, 6 and 9 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449383

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

No publications provided

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
Study First Received: October 5, 2011
Last Updated: August 13, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013