Clinical trial NCT05447481: Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults
Official title: A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Keywords: adults
functional constipation
inulin-type fructans
Lead sponsor: Sensus
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
name: Wageningen University
First posted: 2022-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type fructans in adults with functional constipation.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in stool frequency
timeFrame: During the 12 week intervention period
Secondary outcomes:
measure: Change in stool consistency
timeFrame: During the 12 week intervention period
measure: Patient Assessment of Constipation Symptoms
timeFrame: During the 12 week intervention period
measure: Quality of life using the PAC-QOL questionnaire
timeFrame: During the 12 week intervention period
measure: Physical activity
timeFrame: During the 12 week intervention period
measure: Resort to laxatives
timeFrame: During the 12 week intervention period
measure: Gut microbiota composition
timeFrame: During the 12 week intervention period
Other outcomes:
Locations:
Study officials:
affiliation: Sensus BV
name: Elaine E Vaughan, PhD
role: STUDY_CHAIR
References: