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

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ClinicalTrials.gov Identifier: NCT01897649
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : July 12, 2013
Sponsor:
Collaborator:
Roquette Freres
Information provided by (Responsible Party):
Nealth Sarl

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Microbiota Dietary Fibers Dietary Supplement: NUTRIOSE FB06 Dietary Supplement: GLUCIDEX 21 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: NUTRIOSE
group of volunteers fed with NUTRIOSE
Dietary Supplement: NUTRIOSE FB06
15g/day NUTRIOSE FB06

Active Comparator: GLUCIDEX
gruop of volunteers fed with GLUCIDEX
Dietary Supplement: GLUCIDEX 21
15g/day GLUCIDEX 21




Primary Outcome Measures :
  1. Clostridium Perfringens rate in stool [ Time Frame: D0 ; D14 ; D28 ]

Secondary Outcome Measures :
  1. digestive tolerance [ Time Frame: J0 to J28 (every day) ]
  2. stool pH [ Time Frame: D0 ; D14; D28 ]
  3. total stool flora [ Time Frame: D0 ; D14 ; D28 ]
  4. Bacteroides rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  5. Eubacterium rectal rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  6. Clostridium coccoides rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  7. Clostridium leptum rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  8. Bifidobacteria rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  9. Lactobacteria rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  10. Streptococcus rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  11. Enterococcus rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  12. Bacteroidetes rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  13. Actinobacteria rate in stool [ Time Frame: D0 ; D14; D28 ]
  14. Firmicutes rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  15. E. Coli rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  16. Clostridium difficile rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  17. Faecalibacterium prausnitzii rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  18. Clostridium difficile typa A and B rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  19. E. Coli EIEC + EPEC (eae gene) rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  20. Shigella + E. Coli EIEC (ipaH gene) rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  21. Listeria Monocytogenes rate in stool [ Time Frame: D0 ; D14 ; D28 ]
  22. Yersinia Enterocolitica rate in stool [ Time Frame: D0 ; D14 ; D28 ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897649


Locations
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France
Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie
Bobigny, France, 93009
Sponsors and Collaborators
Nealth Sarl
Roquette Freres
Investigators
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Principal Investigator: Robert BENAMOUZIG, MD,PhD Centre de Recherche en Nutrition Humaine d'Ile-de-France