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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
| Wageningen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chicory inulin-type fructan - placebo | Experimental | Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin |
|
| Placebo - chicory inulin-type fructan | Experimental | Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chicory inulin-type fructan | Dietary Supplement | Dietary supplement: chicory inulin-type fructan |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine E Vaughan, PhD | Sensus BV | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41233756 | Derived | 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. |
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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.
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Subjects were blinded to the study treatment that they received
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 |