NCT01909323CompletedNot Applicable
Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults
Syral2 sites in 1 country36 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Composite score of gastrointestinal symptoms in the 24h following the consumption of products
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
- Not provided
Arms & Interventions
maltitol alone
Experimental
Intervention: maltitol alone (Other)
sugary dessert cream
Placebo Comparator
Intervention: Placebo (Other)
maltitol 85% / FOS 15%
Experimental
Intervention: maltitol 85% / FOS15% (Other)
maltitol 68% / FOS 32%
Experimental
Intervention: maltitol 68% / FOS 32% (Other)
maltitol 50% / FOS 50%
Experimental
Intervention: maltitol 50% / FOS 50% (Other)
FOS alone
Experimental
Intervention: FOS alone (Other)
Outcomes
Primary Outcomes
Composite score of gastrointestinal symptoms in the 24h following the consumption of products
Time Frame: 24 hours
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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