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

Constipation - Functional Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447481
• Other study ID #: AFCRO-058
• Status: Completed
• Phase: N/A
• Start date: November 11, 2015
• Est. completion date: July 28, 2016

Study information

• Verified date: July 2022
• Source: Sensus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Dietary Supplement:
• chicory inulin-type fructan
Dietary supplement: chicory inulin-type fructan

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sensus	Atlantia Food Clinical Trials, Wageningen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in stool consistency	Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.	During the 12 week intervention period
Secondary	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
Secondary	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
Secondary	Physical activity	Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)	During the 12 week intervention period
Secondary	Resort to laxatives	Determine the resort to laxatives of the subjects	During the 12 week intervention period
Secondary	Gut microbiota composition	Determine the effect of chicory inulin-type fructans on gut microbiota composition	During the 12 week intervention period