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

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: Microbiota; Dietary Fibers
• Intervention / Treatment: Dietary supplement: NUTRIOSE FB06; Dietary supplement: GLUCIDEX 21

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

Participation Criteria

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

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clostridium Perfringens rate in stool	D0 ; D14 ; D28

Secondary Outcome Measures

Outcome Measure	Time Frame
digestive tolerance	J0 to J28 (every day)
stool pH	D0 ; D14; D28
total stool flora	D0 ; D14 ; D28
Bacteroides rate in stool	D0 ; D14 ; D28
Eubacterium rectal rate in stool	D0 ; D14 ; D28
Clostridium coccoides rate in stool	D0 ; D14 ; D28
Clostridium leptum rate in stool	D0 ; D14 ; D28
Bifidobacteria rate in stool	D0 ; D14 ; D28
Lactobacteria rate in stool	D0 ; D14 ; D28
Streptococcus rate in stool	D0 ; D14 ; D28
Enterococcus rate in stool	D0 ; D14 ; D28
Bacteroidetes rate in stool	D0 ; D14 ; D28
Actinobacteria rate in stool	D0 ; D14; D28
Firmicutes rate in stool	D0 ; D14 ; D28
E. Coli rate in stool	D0 ; D14 ; D28
Clostridium difficile rate in stool	D0 ; D14 ; D28
Faecalibacterium prausnitzii rate in stool	D0 ; D14 ; D28
Clostridium difficile typa A and B rate in stool	D0 ; D14 ; D28
E. Coli EIEC + EPEC (eae gene) rate in stool	D0 ; D14 ; D28
Shigella + E. Coli EIEC (ipaH gene) rate in stool	D0 ; D14 ; D28
Listeria Monocytogenes rate in stool	D0 ; D14 ; D28
Yersinia Enterocolitica rate in stool	D0 ; D14 ; D28

Collaborators and Investigators

• Sponsor: Nealth Sarl
• Collaborators: Roquette Freres
• Investigators: Principal Investigator: Robert BENAMOUZIG, MD,PhD, Centre de Recherche en Nutrition Humaine d'Ile-de-France

Publications and helpful links

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

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

• Keywords: microbiota; functional food; digestive tolerance; bifidogenic effect
• Other Study ID Numbers: ROQ_NUTRIFLORE10