Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 14, 2008
February 16, 2009
February 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00639561 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Calibrated Diets and Human Intestinal Microflora
Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Bacteria
  • Dietary Supplement: 10 g of fibres per day
    10 g of fibres per day
    Other Name: low fibres
  • Dietary Supplement: 40 g of fibres per day
    40g of fibres per day
    Other Name: high fibres
  • Experimental: A
    diet composed of 10g of fibre per day
    Intervention: Dietary Supplement: 10 g of fibres per day
  • Experimental: B
    diet composed of 40g of fibre per day
    Intervention: Dietary Supplement: 40 g of fibres per day

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00639561
DCIC 06 12
No
University Hospital of Grenoble, Direction de la recherche clinique
University Hospital, Grenoble
  • Centre de Recherche en Nutrition Humaine Rhone-Alpe
  • Institut National de la Recherche Agronomique
Principal Investigator: Eric Fontaine, MDPhD University Hospital, Grenoble
University Hospital, Grenoble
February 2009

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