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

NCT ID: NCT05447481

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-11
• Study Completion Date: 2016-07-28

Brief Summary

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.

Conditions

Constipation - Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chicory inulin-type fructan - placebo

Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin

Group Type: EXPERIMENTAL

chicory inulin-type fructan

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement: chicory inulin-type fructan

Placebo - chicory inulin-type fructan

Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan

Group Type: EXPERIMENTAL

chicory inulin-type fructan

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement: chicory inulin-type fructan

Interventions

chicory inulin-type fructan

Dietary supplement: chicory inulin-type fructan

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Wageningen University

OTHER

Sponsor Role: collaborator

Sensus

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine E Vaughan, PhD

Role: STUDY_CHAIR

Sensus BV

Other Identifiers

AFCRO-058

Identifier Type: -

Identifier Source: org_study_id