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

Study Overview
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Brief Summary
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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.

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

Conditions
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Constipation - Functional

Intervention / Treatment
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* Dietary Supplement: chicory inulin-type fructan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chicory inulin-type fructan - placebo<br>Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin | Dietary Supplement: chicory inulin-type fructan<br>* Dietary supplement: chicory inulin-type fructan<br>|
| Experimental: Placebo - chicory inulin-type fructan<br>Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan | Dietary Supplement: chicory inulin-type fructan<br>* Dietary supplement: chicory inulin-type fructan<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adults, functional constipation, inulin-type fructans