Skip to main content
OpenTrials
Completed

NCT Number: NCT01449383

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low meat high fibre

Dietary Supplement

less than 30g red meat and at least 40g dietary fibre per day

high meat low fibre

Dietary Supplement

at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day

Primary outcomes

  1. change in gut microbiota composition

    Time frame: baseline, week 3, 6 and 9

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

  • Quadram Institute Bioscience
  • Umeå University
  • VTT Technical Research Centre of Finland

Registry information

Official study 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

Acronym: TORNADO

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.