Constipation - Functional
Conditions
Keywords
adults, functional constipation, inulin-type fructans
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.
Interventions
DIETARY_SUPPLEMENTchicory inulin-type fructan
Dietary supplement: chicory inulin-type fructan
Sponsors
Atlantia Food Clinical Trials
Wageningen University
Sensus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Subjects were blinded to the study treatment that they received
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool frequency | During the 12 week intervention period | Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Constipation Symptoms | During the 12 week intervention period | Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire. |
| Quality of life using the PAC-QOL questionnaire | During the 12 week intervention period | Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire |
| Change in stool consistency | During the 12 week intervention period | Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects. |
| Resort to laxatives | During the 12 week intervention period | Determine the resort to laxatives of the subjects |
| Gut microbiota composition | During the 12 week intervention period | Determine the effect of chicory inulin-type fructans on gut microbiota composition |
| Physical activity | During the 12 week intervention period | Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ) |
Outcome results
None listed