- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897649
Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota. (ROQ_NUTRIFLORE)
July 9, 2013 updated by: Nealth Sarl
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bobigny, France, 93009
- Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
- Inclusion in another clinical study
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NUTRIOSE
group of volunteers fed with NUTRIOSE
|
15g/day NUTRIOSE FB06
|
Active Comparator: GLUCIDEX
gruop of volunteers fed with GLUCIDEX
|
15g/day GLUCIDEX 21
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clostridium Perfringens rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
digestive tolerance
Time Frame: J0 to J28 (every day)
|
J0 to J28 (every day)
|
stool pH
Time Frame: D0 ; D14; D28
|
D0 ; D14; D28
|
total stool flora
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Bacteroides rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Eubacterium rectal rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Clostridium coccoides rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Clostridium leptum rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Bifidobacteria rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Lactobacteria rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Streptococcus rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Enterococcus rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Bacteroidetes rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Actinobacteria rate in stool
Time Frame: D0 ; D14; D28
|
D0 ; D14; D28
|
Firmicutes rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
E. Coli rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Clostridium difficile rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Faecalibacterium prausnitzii rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Clostridium difficile typa A and B rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
E. Coli EIEC + EPEC (eae gene) rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Shigella + E. Coli EIEC (ipaH gene) rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Listeria Monocytogenes rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Yersinia Enterocolitica rate in stool
Time Frame: D0 ; D14 ; D28
|
D0 ; D14 ; D28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert BENAMOUZIG, MD,PhD, Centre de Recherche en Nutrition Humaine d'Ile-de-France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 9, 2013
First Submitted That Met QC Criteria
July 9, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
July 12, 2013
Last Update Submitted That Met QC Criteria
July 9, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- ROQ_NUTRIFLORE10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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