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MicrobiotaPhase 1ROQ_NUTRIFLORENCT01897649

Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.

A Phase 1 study testing NUTRIOSE FB06 and GLUCIDEX 21 in people with Microbiota and Dietary Fibers, run by Nealth Sarl at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Microbiota, Dietary Fibers
What is being tested?
NUTRIOSE FB06 and GLUCIDEX 21
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Jun 2012to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 20 to 50 years,
  • BMI 18 to 25 kg/m2,
  • absence of known or scalable organic or psychiatric disease
  • no history of chronic gastrointestinal disease
  • having a bowel regularity (1-3 defecation per day, of normal consistency),
  • person without medication during the study (especially laxatives, anti diarrheal) (except contraceptives in women)
Show all 13Show fewer
  • having normal laboratory hepatic and renal tests (ASAT, ALAT, GGT, urea, creatinine)
  • no pregnant nor nursing women
  • covered by Social Security
  • negative serology for hepatitis B/C and HIV
  • who signed the informed consent form
  • subjects receiving over 4,500 Euros in the last 12 months (including the present study)
  • subjects presenting risk of non-compliance in the opinion of the recruiting doctor.

Who cannot join

  • persons abusing drugs (laxatives, anti-diarrheal)
  • person who doesn't want to stop taking food supplements containing pre- or probiotics during time of the study
  • person intolerant to gluten and / or allergic to wheat flour
  • person in vegetarian or vegan diet

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

    Bobigny, 93009

Other trials in France

About this study

Official title: Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.

NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." The objective of this research is to determine, among healthy subjects, the effect of this dietary fiber on changes in gut microbiota and digestive tolerance during a 28 days consumption. Microbiological analyzes will be performed by RT-PCR. Digestive tolerance will be measured by the intelligence of a questionnaire by volunteers.

Being tested
NUTRIOSE FB06, GLUCIDEX 21
Keywords
functional food, digestive tolerance, microbiota, bifidogenic effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NUTRIOSE FB06Dietary supplement

    15g/day NUTRIOSE FB06

  • GLUCIDEX 21Dietary supplement

    15g/day GLUCIDEX 21

Study groups in NCT01897649
Study groupRoleWhat they receive
NUTRIOSEExperimentalgroup of volunteers fed with NUTRIOSE
Receives: Dietary Supplement: NUTRIOSE FB06
GLUCIDEXActive comparatorgruop of volunteers fed with GLUCIDEX
Receives: Dietary Supplement: GLUCIDEX 21

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clostridium Perfringens rate in stool

    Measured: D0 ; D14 ; D28

Secondary outcomes (22)

  1. digestive tolerance

    Measured: J0 to J28 (every day)

  2. stool pH

    Measured: D0 ; D14; D28

  3. total stool flora

    Measured: D0 ; D14 ; D28

  4. Bacteroides rate in stool

    Measured: D0 ; D14 ; D28

  5. Eubacterium rectal rate in stool

    Measured: D0 ; D14 ; D28

  6. Clostridium coccoides rate in stool

    Measured: D0 ; D14 ; D28

  7. Clostridium leptum rate in stool

    Measured: D0 ; D14 ; D28

  8. Bifidobacteria rate in stool

    Measured: D0 ; D14 ; D28

  9. Lactobacteria rate in stool

    Measured: D0 ; D14 ; D28

  10. Streptococcus rate in stool

    Measured: D0 ; D14 ; D28

  11. Enterococcus rate in stool

    Measured: D0 ; D14 ; D28

  12. Bacteroidetes rate in stool

    Measured: D0 ; D14 ; D28

  13. Actinobacteria rate in stool

    Measured: D0 ; D14; D28

  14. Firmicutes rate in stool

    Measured: D0 ; D14 ; D28

  15. E. Coli rate in stool

    Measured: D0 ; D14 ; D28

  16. Clostridium difficile rate in stool

    Measured: D0 ; D14 ; D28

  17. Faecalibacterium prausnitzii rate in stool

    Measured: D0 ; D14 ; D28

  18. Clostridium difficile typa A and B rate in stool

    Measured: D0 ; D14 ; D28

  19. E. Coli EIEC + EPEC (eae gene) rate in stool

    Measured: D0 ; D14 ; D28

  20. Shigella + E. Coli EIEC (ipaH gene) rate in stool

    Measured: D0 ; D14 ; D28

  21. Listeria Monocytogenes rate in stool

    Measured: D0 ; D14 ; D28

  22. Yersinia Enterocolitica rate in stool

    Measured: D0 ; D14 ; D28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897649
Sponsor's protocol ID
ROQ_NUTRIFLORE10
Acronym
ROQ_NUTRIFLORE
Status last verified
Jul 2013
First submitted
9 Jul 2013
Last updated
12 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

    PubMed 21164548

  • Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE(R) dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

    PubMed 21591985

  • Pasman W, Wils D, Saniez MH, Kardinaal A. Long-term gastrointestinal tolerance of NUTRIOSE FB in healthy men. Eur J Clin Nutr. 2006 Aug;60(8):1024-34. doi: 10.1038/sj.ejcn.1602418. Epub 2006 Feb 15.

    PubMed 16482066

  • Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24. doi: 10.1128/AEM.71.5.2318-2324.2005.

    PubMed 15870317

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NUTRIOSE FB06 and GLUCIDEX 21 in people with Microbiota and Dietary Fibers, run by Nealth Sarl at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clostridium Perfringens rate in stool (time frame: D0 ; D14 ; D28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897649, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.

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