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

October 5, 2011
August 13, 2012
November 2010
August 2012   (final data collection date for primary outcome measure)
change in gut microbiota composition [ Time Frame: baseline, week 3, 6 and 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01449383 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Intestinal Microbiota
  • Blood Markers
  • Dietary Supplement: low meat high fibre
    less than 30g red meat and at least 40g 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
  • Active Comparator: low meat high fibre (lmhf)
    consumption of less than 30g red meat per day and at least 40g dietary fibre per day
    Intervention: Dietary Supplement: low meat high fibre
  • Active Comparator: high meat low fibre (hmlf)
    consumption of 200g red meat and not more than 20g dietary fibre per day
    Intervention: Dietary Supplement: high meat low fibre
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01449383
KBBE-2007-2-2-07_WP2.4
No
Jana Foerster, German Institute of Human Nutrition
German Institute of Human Nutrition
  • Umeå University
  • Institute of Food Research
  • VTT Technical Research Centre of Finland
Principal Investigator: Jana Foerster, PhD student German Institute of Human Nutrition Potsdam-Rehbruecke
German Institute of Human Nutrition
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP