NCT01897649

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
Last Updated

July 12, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

July 9, 2013

Last Update Submit

July 9, 2013

Conditions

MicrobiotaDietary Fibers

Keywords

functional fooddigestive tolerancemicrobiotabifidogenic effect

Outcome Measures

Primary Outcomes (1)

  • Clostridium Perfringens rate in stool

    D0 ; D14 ; D28

Secondary Outcomes (22)

  • 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

  • +17 more secondary outcomes

Study Arms (2)

NUTRIOSE

EXPERIMENTAL

group of volunteers fed with NUTRIOSE

Dietary Supplement: NUTRIOSE FB06

GLUCIDEX

ACTIVE COMPARATOR

gruop of volunteers fed with GLUCIDEX

Dietary Supplement: GLUCIDEX 21

Interventions

NUTRIOSE FB06DIETARY_SUPPLEMENT

15g/day NUTRIOSE FB06

NUTRIOSE
GLUCIDEX 21DIETARY_SUPPLEMENT

15g/day GLUCIDEX 21

GLUCIDEX

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Avicenne- Centre de Recherche Sur Volontaires-Service de Gastroenterologie

Bobigny, 93009, France

Location

Related Publications (4)

  • 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.

    PMID: 21164548BACKGROUND

  • 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.

    PMID: 21591985BACKGROUND

  • 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.

    PMID: 16482066BACKGROUND

  • 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.

    PMID: 15870317BACKGROUND

Study Officials

  • Robert BENAMOUZIG, MD,PhD

    Centre de Recherche en Nutrition Humaine d'Ile-de-France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

July 12, 2013

Record last verified: 2013-07

Locations

FR(1)