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Once the patients who are candidates to enter the study are identified, the patients will be randomly be assigned to two groups, according to the sequence:
All patients will be given guidelines for adopting dietary habits and healthy lifestyles to achieve a regular and physiological depositional rhythm and will be given a study supplement and a control supplement, alternatively, for 2 time periods of 3 weeks separated by 2 weeks of wash out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: study+wash out+control | Other | Study product (3 weeks) + wash out (2 weeks) + control product (3 weeks) |
|
| Group B: control+wash out+study | Other | Control product (3 weeks) + wash out (2 weeks) + study product (3 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mixture of fibers + Placebo | Dietary Supplement | Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of clinical change obtained from the difference between the initial value and the final value for a combined score of the frequency of passage of faeces, pain to defecation, consistency of stool. | Combined score between this parameters | From baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Consistency of stool according to Bristol Stool Form Scale | Valuation of stool characteristics (Bristol scale): 7 types of consistency, where type 1 is the hardest consistency. | From baseline to 8 weeks |
| Frequency of stool |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roser De Castellar, MD | Contact | +34 902105243 | Roser.DeCastellar@ordesa.es |
| Name | Affiliation | Role |
|---|---|---|
| Gerardo RodrÃguez, MD | Instituto de Investigación Sanitaria Aragón | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Perpetuo Socorro | Recruiting | Huesca | Aragon | 22006 | Spain |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo + Mixture of fibers | Dietary Supplement | Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks) |
|
Equal to or more than 3 times/week, 1-2 times/week, less than 1 time/week
| From baseline to 8 weeks |
| Change in stool weight | Increase equal to or greater than 50%, increase by 50 - 15%, increase less than 15% | From baseline to 8 weeks |
| Gastrointestinal symptoms related to the constipation | Record in the patient's dairy all the gastrointestinal symptoms during the study | From baseline to 8 weeks |
| Adherence record to the complement intake (Moriski Green test) | 4 questions to the patient about treatment adherence.Patients who follow treatment are considered to be those who answer NO to the four questions and not to those who answer YES to one or more. | At 8 weeks |
| Patient anthropometric measures: weight | Anthropometric records: weight (Kg) | Up to 8 weeks |
| Patient anthropometric measures: size | Anthropometric records: size (cm) | Up to 8 weeks |
| Patient anthropometric measures: waist perimeter | Waist perimeter (cm) | Up to 8 weeks |
| Centro de Salud Amparo Poch | Recruiting | Zaragoza | Aragon | 50018 | Spain |
|
| Centro de Salud Isabel II | Recruiting | Santander | Cantabria | 39002 | Spain |
|