Digestive Tolerance of Maltitol and FOS

NCT ID: NCT01909323

Last Updated: 2013-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Digestive Tolerance in Healthy Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sugary dessert cream

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

maltitol alone

Group Type EXPERIMENTAL

maltitol alone

Intervention Type OTHER

maltitol 85% / FOS 15%

Group Type EXPERIMENTAL

maltitol 85% / FOS15%

Intervention Type OTHER

maltitol 68% / FOS 32%

Group Type EXPERIMENTAL

maltitol 68% / FOS 32%

Intervention Type OTHER

maltitol 50% / FOS 50%

Group Type EXPERIMENTAL

maltitol 50% / FOS 50%

Intervention Type OTHER

FOS alone

Group Type EXPERIMENTAL

FOS alone

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

maltitol 85% / FOS15%

Intervention Type OTHER

maltitol alone

Intervention Type OTHER

maltitol 68% / FOS 32%

Intervention Type OTHER

maltitol 50% / FOS 50%

Intervention Type OTHER

FOS alone

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beghin-Meiji

INDUSTRY

Sponsor Role collaborator

Syral

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Gendre, MD

Role: PRINCIPAL_INVESTIGATOR

Biofortis SAS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Biofortis SAS

Saint-Herblain, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMALTO

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Evaluation of Carbohydrates
NCT03242122 COMPLETED NA