Digestive Tolerance of Maltitol and FOS

Syral

Status: Completed

Conditions: Digestive Tolerance in Healthy Adults

Treatments: Other: Placebo; Other: maltitol alone; Other: maltitol 85% / FOS15%; Other: FOS alone; Other: maltitol 50% / FOS 50%; Other: maltitol 68% / FOS 32%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909323

SMALTO

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 6 patient groups, including a placebo group

sugary dessert cream

Placebo Comparator group

Treatment:

Other: Placebo

maltitol alone

Experimental group

Treatment:

Other: maltitol alone

maltitol 85% / FOS 15%

Experimental group

Treatment:

Other: maltitol 85% / FOS15%

maltitol 68% / FOS 32%

Experimental group

Treatment:

Other: maltitol 68% / FOS 32%

maltitol 50% / FOS 50%

Experimental group

Treatment:

Other: maltitol 50% / FOS 50%

FOS alone

Experimental group

Treatment:

Other: FOS alone