Clinical trial NCT01897649: Effect of 15g Daily Consumption of NUTRIOSE on Healthy Volunteers Microbiota.
Official title: Effect of 15g Daily Consumption of NUTRIOSE During 2 and 4 Weeks on Healthy Volunteers Microbiota and Digestive Tolerance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Microbiota
Dietary Fibers
Keywords: functional food
digestive tolerance
microbiota
bifidogenic effect
Lead sponsor: Nealth Sarl
Sponsor class: NETWORK
Collaborators: name: Roquette Freres
First posted: 2013-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Clostridium Perfringens rate in stool
timeFrame: D0 ; D14 ; D28
Secondary outcomes:
measure: digestive tolerance
timeFrame: J0 to J28 (every day)
measure: stool pH
timeFrame: D0 ; D14; D28
measure: total stool flora
timeFrame: D0 ; D14 ; D28
measure: Bacteroides rate in stool
timeFrame: D0 ; D14 ; D28
measure: Eubacterium rectal rate in stool
timeFrame: D0 ; D14 ; D28
measure: Clostridium coccoides rate in stool
timeFrame: D0 ; D14 ; D28
measure: Clostridium leptum rate in stool
timeFrame: D0 ; D14 ; D28
measure: Bifidobacteria rate in stool
timeFrame: D0 ; D14 ; D28
measure: Lactobacteria rate in stool
timeFrame: D0 ; D14 ; D28
measure: Streptococcus rate in stool
timeFrame: D0 ; D14 ; D28
measure: Enterococcus rate in stool
timeFrame: D0 ; D14 ; D28
measure: Bacteroidetes rate in stool
timeFrame: D0 ; D14 ; D28
measure: Actinobacteria rate in stool
timeFrame: D0 ; D14; D28
measure: Firmicutes rate in stool
timeFrame: D0 ; D14 ; D28
measure: E. Coli rate in stool
timeFrame: D0 ; D14 ; D28
measure: Clostridium difficile rate in stool
timeFrame: D0 ; D14 ; D28
measure: Faecalibacterium prausnitzii rate in stool
timeFrame: D0 ; D14 ; D28
measure: Clostridium difficile typa A and B rate in stool
timeFrame: D0 ; D14 ; D28
measure: E. Coli EIEC + EPEC (eae gene) rate in stool
timeFrame: D0 ; D14 ; D28
measure: Shigella + E. Coli EIEC (ipaH gene) rate in stool
timeFrame: D0 ; D14 ; D28
measure: Listeria Monocytogenes rate in stool
timeFrame: D0 ; D14 ; D28
measure: Yersinia Enterocolitica rate in stool
timeFrame: D0 ; D14 ; D28
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie
Study officials:
affiliation: Centre de Recherche en Nutrition Humaine d'Ile-de-France
name: Robert BENAMOUZIG, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.