Constipation - Functional
Conditions
Brief summary
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: * In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function? * Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)? The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact. Participants will: * Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each. * Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy. * Keep a daily record of bowel habits and dietary intake.
Interventions
DIETARY_SUPPLEMENTPsyllium powder
Psyllium powder: soluble fiber gel forming, provided at 20 g per day (two doses of 10 g each)
DIETARY_SUPPLEMENTFructooligosaccharide
Fructooligosaccharide: prebiotic, provided at 20 g per day (two doses of 10 g each)
Sponsors
Federal University of Minas Gerais
Max Nutri
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Female participants aged 18-59 years. * Willingness to sign the Informed Consent Form . * No restrictions on the consumption of egg or gluten. * No history or diagnosis of gastrointestinal diseases other than functional constipation. * Non-smokers. * No use of prebiotics, probiotics, synbiotics, or antibiotics at least 10 days prior to the study. * No previous surgery affecting gastrointestinal transit. * Willingness to discontinue the use of laxatives at least 4 days prior to scintigraphic imaging. * Participants who do not consume adequate dietary fiber (25-30 g/day) as assessed by dietary recall. * No confirmed or suspected pregnancy during the study. * No self-reported menopause
Exclusion criteria
* Diagnosis of diabetes, severe hyperthyroidism, or hypothyroidism. * Use of opioid medications. * Delayed gastric emptying at 4 hours during the placebo period (participants meeting this criterion will be excluded from final analysis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colonic transit time | This outcome will be assessed at the end of the 6-day consumption period of the fibers of interest. | Colonic transit time will be measured using scintigraphy 24 hours after ingestion of the radiolabeled test meal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying | This outcome will be assessed at the end of the 6-day consumption period of each fiber of interest | Gastric emptying will be evaluated using scintigraphy, with images obtained immediately after ingestion of the radiolabeled test meal and then hourly for 6 hours. |
| Bowel function | The outcome will be assessed throughout the intervention period, during the 6-day consumption of the fibers of interest. | Through questionnaires, the number of bowel movements and gastrointestinal symptoms experienced during the intervention period will be assessed |
| Quality of life assessment | Assessed at baseline and following each treatment phase of the crossover trial | Using a validated questionnaire, the impact of constipation on the quality of life of women with constipation will be assessed. |
| Fecal microbiota | Baseline and at the end of each 6-day intervention period | Fecal samples will be collected before and after the intervention to assess the gut microbiota and short-chain fatty acids. |
| Fecal Short chain fatty acids | Baseline and at the end of each 6-day intervention period | Fecal samples will be collected before and after the intervention to assess the short-chain fatty acids. |
Countries
Brazil
Contacts
CONTACTSimone de Vasconcelos Generoso, PhD
PRINCIPAL_INVESTIGATORSimone de Vasconcelos Generoso, PhD
Department of Nutrition, Federal University of Minas Gerais
Outcome results
None listed