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

NCT05447481 | Completed

• 1 other identifier: AFCRO-058
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

adults; functional constipation; inulin-type fructans

Outcome Measures

Primary Outcomes (1)

• Change in stool frequency

  Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects.

  During the 12 week intervention period

Secondary Outcomes (6)

• Change in stool consistency

  During the 12 week intervention period

• Patient Assessment of Constipation Symptoms

  During the 12 week intervention period

• Quality of life using the PAC-QOL questionnaire

  During the 12 week intervention period

• Physical activity

  During the 12 week intervention period

• Resort to laxatives

  During the 12 week intervention period

Study Arms (2)

Chicory inulin-type fructan - placebo

EXPERIMENTAL

Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin

Dietary Supplement: chicory inulin-type fructan

Placebo - chicory inulin-type fructan

EXPERIMENTAL

Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan

Dietary Supplement: chicory inulin-type fructan

Interventions

chicory inulin-type fructan DIETARY_SUPPLEMENT

Dietary supplement: chicory inulin-type fructan

Chicory inulin-type fructan - placebo; Placebo - chicory inulin-type fructan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensus: lead
• Atlantia Food Clinical Trials: collaborator
• Wageningen University: collaborator

Related Publications (1)

• Puhlmann ML, Wegh CAM, van der Zalm SCC, Dam V, Doolan A, Meyer D, Belzer C, Vaughan EE, Benninga MA, Smidt H. Inulin-induced improvements on bowel habit and gut microbiota in adults with functional constipation: findings of a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2025 Nov 13;25(1):806. doi: 10.1186/s12876-025-04409-6.

  PMID: 41233756 DERIVED

Study Officials

• Elaine E Vaughan, PhD

  Sensus BV

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects were blinded to the study treatment that they received
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: November 11, 2015
• Primary Completion: July 28, 2016
• Study Completion: July 28, 2016
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share