Calibrated Diets and Human Intestinal Microflora - Full Text View

Sponsor:	University Hospital, Grenoble
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

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:	Basic Science, Randomized, Open Label, Dose Comparison, Crossover Assignment
Official Title:	Effect of Controlled Diets on Structural and Functional Dynamic of the Human Intestinal Microflora

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

U.S. FDA Resources

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
A: Experimental diet composed of 10g of fibre per day	Dietary Supplement: 10 g of fibres per day 10 g of fibres per day
B: Experimental diet composed of 40g of fibre per day	Dietary Supplement: 40 g of fibres per day 40g of fibres per day

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

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:

Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Doré J. Direct analysis of genes encoding 16S rRNA from complex communities reveals many novel molecular species within the human gut. Appl Environ Microbiol. 1999 Nov;65(11):4799-807.

Aaltonen LA, Peltomäki P, Leach FS, Sistonen P, Pylkkänen L, Mecklin JP, Järvinen H, Powell SM, Jen J, Hamilton SR, et al. Clues to the pathogenesis of familial colorectal cancer. Science. 1993 May 7;260(5109):812-6.

Moore WE, Moore LH. Intestinal floras of populations that have a high risk of colon cancer. Appl Environ Microbiol. 1995 Sep;61(9):3202-7.

Black AE, Coward WA, Cole TJ, Prentice AM. Human energy expenditure in affluent societies: an analysis of 574 doubly-labelled water measurements. Eur J Clin Nutr. 1996 Feb;50(2):72-92.

Robinson RR, Feirtag J, Slavin JL. Effects of dietary arabinogalactan on gastrointestinal and blood parameters in healthy human subjects. J Am Coll Nutr. 2001 Aug;20(4):279-85.

Tuohy KM, Kolida S, Lustenberger AM, Gibson GR. The prebiotic effects of biscuits containing partially hydrolysed guar gum and fructo-oligosaccharides--a human volunteer study. Br J Nutr. 2001 Sep;86(3):341-8.

Chinda D, Nakaji S, Fukuda S, Sakamoto J, Shimoyama T, Nakamura T, Fujisawa T, Terada A, Sugawara K. The fermentation of different dietary fibers is associated with fecal clostridia levels in men. J Nutr. 2004 Aug;134(8):1881-6.

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

Keywords provided by University Hospital, Grenoble:

digestive system
Diet

ClinicalTrials.gov processed this record on November 22, 2009