Calibrated Diets and Human Intestinal Microflora (AlimIntest)

This study has been completed.
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Institut National de la Recherche Agronomique
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00639561
First received: March 14, 2008
Last updated: February 16, 2009
Last verified: February 2009
  Purpose

The main objective of the study is to realized a collection of feces in order to study the modification of the intestinal microflora according to alimentary fibres


Condition Intervention
Bacteria
Dietary Supplement: 10 g of fibres per day
Dietary Supplement: 40 g of fibres per day

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Modification of the composition or of the functioning of the intestinal microflora during calibrated diets [ Time Frame: at day 1, 4 and 5 of each diet ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modification of the composition or of the functioning of the intestinal microflora during spontaneous diets [ Time Frame: before, between and after calibrated diets ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
diet composed of 10g of fibre per day
Dietary Supplement: 10 g of fibres per day
10 g of fibres per day
Other Name: low fibres
Experimental: B
diet composed of 40g of fibre per day
Dietary Supplement: 40 g of fibres per day
40g of fibres per day
Other Name: high fibres

Detailed Description:

Human intestinal tract count up to 1014 bacteria. We consider that each bacterial flora is composed of more than 500 different species among which only 20% are cultivable. Although this flora is well unknown, it is known that it play a major role in the metabolism of the eating fibers. Dysfunctions of this flora may be implied in numerous local and general pathologies.

It has been shown that probiotics and prebiotics are able to act upon the intestinal flora. On the basis of the personal real-life, it is generally considered acquired that our diet modifies this flora. However not many studies have validated this hypothesis with human normal diet (not artificially enriched with prebiotics or probiotics). The idea that our diet can modified the functioning of our intestinal flora (and so favor certain pathologies or activate recovery) is widely hypothetic.

A best knowledge of the diversity of this flora and to put at disposal tools to study it on a large scale could allow to answer this question. The demonstration that some food components could modify the composition or the functioning of this flora would have considerable consequences in medicine and food processing industry.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18,5 and 25

Exclusion Criteria:

  • Antibiotherapy in the previous month
  • Current Antibiotherapy
  • Gastro-intestinal dysfunction
  • Pregnancy, parturient and feeding woman
  • Person deprived of freedom by judiciary or administrative decision, person in legal protection,
  • Prebiotic and/or osmotic laxatives in the previous month
  • Preparation for coloscopy in the previous month
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00639561

Locations
France
Clinical research center
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Institut National de la Recherche Agronomique
Investigators
Principal Investigator: Eric Fontaine, MDPhD University Hospital, Grenoble
  More Information

Publications:
Responsible Party: University Hospital of Grenoble, Direction de la recherche clinique
ClinicalTrials.gov Identifier: NCT00639561     History of Changes
Other Study ID Numbers: DCIC 06 12
Study First Received: March 14, 2008
Last Updated: February 16, 2009
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
digestive system
Diet

ClinicalTrials.gov processed this record on August 21, 2014