Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults

Sensus

Status

Completed

Conditions

Constipation - Functional

Treatments

Dietary Supplement: chicory inulin-type fructan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05447481

AFCRO-058

Details and patient eligibility

About

Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to give written informed consent
Between 18 and 75 years of age
Have functional constipation according to the Rome III Diagnostic Criteria
Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study
The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study
Subject is in general good health as determined by the investigator.

Exclusion criteria

Subjects less than 18 and greater than 75 years of age
Females who are pregnant, lactating or wish to become pregnant during the study.
Subjects who are hypersensitive to any of the components of the test product,
Subjects who have an obstructive or metabolic aetiology for constipation,
Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
Subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit,
Subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit