Digestive Tolerance of Maltitol and FOS

July 25, 2013 updated by: Syral

Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Herblain, France, 44800
        • Biofortis Sas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: sugary dessert cream
Other: Placebo
Experimental: maltitol alone
Other: maltitol alone
Experimental: maltitol 85% / FOS 15%
Other: maltitol 85% / FOS15%
Experimental: maltitol 68% / FOS 32%
Other: maltitol 68% / FOS 32%
Experimental: maltitol 50% / FOS 50%
Other: maltitol 50% / FOS 50%
Experimental: FOS alone
Other: FOS alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite score of gastrointestinal symptoms in the 24h following the consumption of products
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences
Time Frame: 24 and 48 hours
24 and 48 hours
Stool frequcency and consistency
Time Frame: 24 & 48 hours
24 & 48 hours
Glycaemic response
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syral

Collaborators

Beghin-Meiji

Investigators

  • Principal Investigator: David Gendre, MD, Biofortis Sas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • SMALTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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