NCT01909323

Brief Summary

Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 24, 2013

Last Update Submit

July 25, 2013

Conditions

Digestive Tolerance in Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Composite score of gastrointestinal symptoms in the 24h following the consumption of products

    24 hours

Secondary Outcomes (3)

  • Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences

    24 and 48 hours

  • Stool frequcency and consistency

    24 & 48 hours

  • Glycaemic response

    2 hours

Study Arms (6)

sugary dessert cream

PLACEBO COMPARATOR
Other: Placebo

maltitol alone

EXPERIMENTAL
Other: maltitol alone

maltitol 85% / FOS 15%

EXPERIMENTAL
Other: maltitol 85% / FOS15%

maltitol 68% / FOS 32%

EXPERIMENTAL
Other: maltitol 68% / FOS 32%

maltitol 50% / FOS 50%

EXPERIMENTAL
Other: maltitol 50% / FOS 50%

FOS alone

EXPERIMENTAL
Other: FOS alone

Interventions

maltitol 85% / FOS15%OTHER
maltitol 85% / FOS 15%
maltitol aloneOTHER
maltitol alone
maltitol 68% / FOS 32%OTHER
maltitol 68% / FOS 32%
maltitol 50% / FOS 50%OTHER
maltitol 50% / FOS 50%
FOS aloneOTHER
FOS alone
PlaceboOTHER
sugary dessert cream

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.5 and 30
  • normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
  • subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
  • subjects not sufferinf from IBS according to Rome III criteria
  • subjects not using mdeiction which could affect nutrients absoprtion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biofortis SAS

Saint-Herblain, 44800, France

Location

MeSH Terms

Interventions

maltitol

Study Officials

  • David Gendre, MD

    Biofortis SAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2013

First Posted

July 26, 2013

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

November 1, 2012

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations

FR(1)