Calibrated Diets and Human Intestinal Microflora

NCT ID: NCT00639561

Last Updated: 2009-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Bacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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A

diet composed of 10g of fibre per day

Group Type EXPERIMENTAL

10 g of fibres per day

Intervention Type DIETARY_SUPPLEMENT

10 g of fibres per day

B

diet composed of 40g of fibre per day

Group Type EXPERIMENTAL

40 g of fibres per day

Intervention Type DIETARY_SUPPLEMENT

40g of fibres per day

Interventions

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10 g of fibres per day

10 g of fibres per day

Intervention Type DIETARY_SUPPLEMENT

40 g of fibres per day

40g of fibres per day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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low fibres high fibres

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre de Recherche en Nutrition Humaine Rhone-Alpe

OTHER

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Direction de la recherche clinique

Principal Investigators

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Eric Fontaine, MDPhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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Clinical research center

Grenoble, , France

Site Status

Countries

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France

References

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Suau A, Bonnet R, Sutren M, Godon JJ, Gibson GR, Collins MD, Dore 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. doi: 10.1128/AEM.65.11.4799-4807.1999.

Reference Type BACKGROUND
PMID: 10543789 (View on PubMed)

Aaltonen LA, Peltomaki P, Leach FS, Sistonen P, Pylkkanen L, Mecklin JP, Jarvinen 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. doi: 10.1126/science.8484121.

Reference Type BACKGROUND
PMID: 8484121 (View on PubMed)

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. doi: 10.1128/aem.61.9.3202-3207.1995.

Reference Type BACKGROUND
PMID: 7574628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8641250 (View on PubMed)

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. doi: 10.1080/07315724.2001.10719048.

Reference Type BACKGROUND
PMID: 11506055 (View on PubMed)

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. doi: 10.1079/bjn2001394.

Reference Type BACKGROUND
PMID: 11570986 (View on PubMed)

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. doi: 10.1093/jn/134.8.1881.

Reference Type BACKGROUND
PMID: 15284370 (View on PubMed)

Other Identifiers

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DCIC 06 12

Identifier Type: -

Identifier Source: org_study_id

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