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| Name | Class |
|---|---|
| Max Nutri | UNKNOWN |
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The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are:
The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiber A | Experimental | In this arm, participants start by undergoing scintigraphic imaging and data collection for the control period. Then, in a randomized order, they receive Fiber A for 6 days, at a dose of 20 g per day divided into two 10 g doses, after which scintigraphic imaging and data collection are repeated. Following a 7-day washout period, participants begin Fiber B consumption, also at 20 g per day divided into two 10 g doses, and return for new scintigraphic imaging and data collection. |
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| Fiber B | Experimental | In this arm, participants start by undergoing scintigraphic imaging and data collection for the control period. Then, in a randomized order, they receive Fiber B for 6 days, at a dose of 20 g per day divided into two 10 g doses, after which scintigraphic imaging and data collection are repeated. Following a 7-day washout period, participants begin Fiber A consumption, also at 20 g per day divided into two 10 g doses, and return for new scintigraphic imaging and data collection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium powder | Dietary Supplement | Psyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonic transit time | Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal. | This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying | Gastric emptying will be evaluated using scintigraphy, with images obtained immediately after ingestion of the radiolabeled test meal and then hourly for 6 hours. | This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest |
| Bowel function |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone de Vasconcelos Generoso, PhD | Contact | 55(031) 988128650 | simonenutufmg@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Simone de Vasconcelos Generoso, PhD | Department of Nutrition, Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Nursing, Federal University of Minas Gerais | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
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| Fructooligosaccharide | Dietary Supplement | Fructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each) |
|
Through questionnaires, the number of bowel movements and gastrointestinal symptoms experienced during the intervention period will be assessed |
| The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest. |
| Quality of life assessment | Using a validated questionnaire, the impact of constipation on the quality of life of women with constipation will be assessed. | Assessed at baseline and following each treatment phase of the crossover trial |
| Fecal microbiota | Fecal samples will be collected before and after the intervention to assess the gut microbiota and short-chain fatty acids. | Baseline and at the end of each 6-day intervention period |
| Fecal Short chain fatty acids | Fecal samples will be collected before and after the intervention to assess the short-chain fatty acids. | Baseline and at the end of each 6-day intervention period |
| ID | Term |
|---|---|
| C116580 | fructooligosaccharide |
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