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Digestive Tolerance of Maltitol and FOS

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01909323
Enrollment
36
Registered
2013-07-26
Start date
2011-09-30
Completion date
2012-11-30
Last updated
2013-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive Tolerance in Healthy Adults

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.

Interventions

OTHERmaltitol 85% / FOS15%
OTHERmaltitol alone
OTHERmaltitol 68% / FOS 32%
OTHERmaltitol 50% / FOS 50%
OTHERFOS alone
OTHERPlacebo

Sponsors

Beghin-Meiji
CollaboratorINDUSTRY
Syral
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frame
Composite score of gastrointestinal symptoms in the 24h following the consumption of products24 hours

Secondary

MeasureTime frame
Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences24 and 48 hours
Stool frequcency and consistency24 & 48 hours
Glycaemic response2 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026