Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

Intestinal Microbiota Clinical Trial

— TORNADO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449383
• Other study ID #: KBBE-2007-2-2-07_WP2.4
• Status: Completed
• Phase: N/A
• First received: October 5, 2011
• Last updated: August 13, 2012
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Markers
• Intestinal Microbiota

Intervention

Dietary Supplement:
• low meat high fibre
less than 30g red meat and at least 40g dietary fibre per day
• high meat low fibre
at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Institute of Food Research, Umeå University, VTT Technical Research Centre of Finland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in gut microbiota composition		baseline, week 3, 6 and 9	No
Secondary	change in anthropometry	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	baseline, week 3, 6 and 9	No
Secondary	change in blood markers	clinical blood count, including Hba1c, gamma-GT, cholesterol, HDL, LDL, Triglycerides, s-creatinin, CRP	baseline, week 3, 6 and 9	No
Secondary	change in salivary microbial composition		baseline, week 3, 6 and 9	No