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| Name | Class |
|---|---|
| Gladys Barrera Acevedo | UNKNOWN |
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We will conduct a 2 months clinical intervention in which a 20 g appled derived fibre supplement will be compared with a placebo without fibre. The main outcome will be the reduction in the Gastrointestinal System Rating Scale
Participants with constipation and mild gastrointestinal symptoms will be invited to participate. Those with alarming symptoms such as gastrointestinal bleeding or weight loss, those using laxatives or medications with anticholinergic actions will be excluded from the study At baseline, participants will be weighed and interrogated about Their gastrointestinal symptoms using the "Gastrointestinal symptom rating scale" Their type of stools using the Bristol visual stool scale The number of complete spontaneous bowel movements per week Afterwards, they will be randomized, balancing by age, gender and body mass index to receive in a doubly blind fashion A 20 g/day powder with apple derived fiber A similarly looking placebo powder The intervention will last 8 weeks. Every two weeks, participants will be cited to provide a new supply of the product, retrieve the used vials and be interrogated using the same tools as baseline. At the end of the intervention, participants will be weighed again
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active product | Active Comparator | A powder containing 20 g of apple derived fiber will be consumed daily |
|
| Placebo | Placebo Comparator | A rice derived placebo devoid of fiber and aromatized with apple fragancy will be provided |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple derived fiber | Dietary Supplement | This is a combination of soluble and insoluble fiber |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptom rating scale | This scale assesses abdominal pain, bloating and type of stools | every 2 weeks during 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complete spontaneous bowel movements per week | the title is auto-explicative | every 2 weeks during 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
having serious cardiovascular, kidney or hepatic diseases
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francisco Perez, Ph D | Contact | +56229781411 | fperez@inta.uchile.cl | |
| Rodrigo Troncoso, PhD | Contact | +56229781486 | rtroncoso@inta.uchile.cl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutrition and Food Technology University of Chile | Recruiting | Santiago | Santiago Metropolitan | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14531531 | Result | Wiklund IK, Fullerton S, Hawkey CJ, Jones RH, Longstreth GF, Mayer EA, Peacock RA, Wilson IK, Naesdal J. An irritable bowel syndrome-specific symptom questionnaire: development and validation. Scand J Gastroenterol. 2003 Sep;38(9):947-54. doi: 10.1080/00365520310004209. | |
| 27618593 | Result | Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13. |
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All information will be in databases without any identification information of participants
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2021 | |
| Reset | Feb 22, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2021 | Feb 22, 2021 |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D005767 | Gastrointestinal Diseases |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |
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Double blind parallel study comparing a fiber supplement with a fiberless placebo
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Active product and placebo will have the same appearance. All vials will have an unique numerical code