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OpenTrials
Completed

NCT Number: NCT01909323

Digestive Tolerance of Maltitol and FOS

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.

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Key information

Conditions

Digestive Tolerance in Healthy Adults

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis SAS

Saint-Herblain, 44800, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

maltitol 85% / FOS15%

Other

maltitol alone

Other

maltitol 68% / FOS 32%

Other

maltitol 50% / FOS 50%

Other

FOS alone

Other

Placebo

Other

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

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

    Time frame: 24 and 48 hours

  2. Stool frequcency and consistency

    Time frame: 24 & 48 hours

  3. Glycaemic response

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Syral

Industry

Collaborators

  • Beghin-Meiji

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.