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

Microbiota Clinical Trial

— ROQ_NUTRIFLORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897649
• Other study ID #: ROQ_NUTRIFLORE10
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2013
• Last updated: July 9, 2013
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Nealth Sarl
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Dietary Fibers
• Microbiota

Intervention

Dietary Supplement:
• NUTRIOSE FB06
15g/day NUTRIOSE FB06
• GLUCIDEX 21
15g/day GLUCIDEX 21

Locations

Country	Name	City	State
France	Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie	Bobigny

Sponsors (2)

Lead Sponsor	Collaborator
Nealth Sarl	Roquette Freres

Country where clinical trial is conducted

France, 

References & Publications (4)

Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE® 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. — View 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. — View 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. — View 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. Epub 2006 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clostridium Perfringens rate in stool		D0 ; D14 ; D28	No
Secondary	digestive tolerance		J0 to J28 (every day)	No
Secondary	stool pH		D0 ; D14; D28	No
Secondary	total stool flora		D0 ; D14 ; D28	No
Secondary	Bacteroides rate in stool		D0 ; D14 ; D28	No
Secondary	Eubacterium rectal rate in stool		D0 ; D14 ; D28	No
Secondary	Clostridium coccoides rate in stool		D0 ; D14 ; D28	No
Secondary	Clostridium leptum rate in stool		D0 ; D14 ; D28	No
Secondary	Bifidobacteria rate in stool		D0 ; D14 ; D28	No
Secondary	Lactobacteria rate in stool		D0 ; D14 ; D28	No
Secondary	Streptococcus rate in stool		D0 ; D14 ; D28	No
Secondary	Enterococcus rate in stool		D0 ; D14 ; D28	No
Secondary	Bacteroidetes rate in stool		D0 ; D14 ; D28	No
Secondary	Actinobacteria rate in stool		D0 ; D14; D28	No
Secondary	Firmicutes rate in stool		D0 ; D14 ; D28	No
Secondary	E. Coli rate in stool		D0 ; D14 ; D28	No
Secondary	Clostridium difficile rate in stool		D0 ; D14 ; D28	No
Secondary	Faecalibacterium prausnitzii rate in stool		D0 ; D14 ; D28	No
Secondary	Clostridium difficile typa A and B rate in stool		D0 ; D14 ; D28	No
Secondary	E. Coli EIEC + EPEC (eae gene) rate in stool		D0 ; D14 ; D28	No
Secondary	Shigella + E. Coli EIEC (ipaH gene) rate in stool		D0 ; D14 ; D28	No
Secondary	Listeria Monocytogenes rate in stool		D0 ; D14 ; D28	No
Secondary	Yersinia Enterocolitica rate in stool		D0 ; D14 ; D28	No