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

A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation

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.

Study Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Dietary supplement: chicory inulin-type fructan

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chicory inulin-type fructan - placebo; Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin	Dietary supplement: chicory inulin-type fructan; Dietary supplement: chicory inulin-type fructan
Experimental: Placebo - chicory inulin-type fructan; Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan	Dietary supplement: chicory inulin-type fructan; Dietary supplement: chicory inulin-type fructan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stool consistency	Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.	During the 12 week intervention period
Patient Assessment of Constipation Symptoms	Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire.	During the 12 week intervention period
Quality of life using the PAC-QOL questionnaire	Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire	During the 12 week intervention period
Physical activity	Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)	During the 12 week intervention period
Resort to laxatives	Determine the resort to laxatives of the subjects	During the 12 week intervention period
Gut microbiota composition	Determine the effect of chicory inulin-type fructans on gut microbiota composition	During the 12 week intervention period

Collaborators and Investigators

• Sponsor: Sensus
• Collaborators: Wageningen University; Atlantia Food Clinical Trials
• Investigators: Study Chair: Elaine E Vaughan, PhD, Sensus BV

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2015
• Primary Completion (Actual): July 28, 2016
• Study Completion (Actual): July 28, 2016

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: adults; functional constipation; inulin-type fructans
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: AFCRO-058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No