Status:
COMPLETED
Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
Maag Lever Darm Stichting
TNO
Conditions:
Constipation
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Rationale: constipation-related complaints are prevalent in 5-20% of the population. Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool weight, stool frequen...
Eligibility Criteria
Inclusion
- Age 18- 55 years
- BMI \<30 kg/m2
- Has constipation related complaints: response \<6 to the question "how satisfied are you with your stool pattern", which is rated on a visual analog scale (VAS) from 1-10, together with at least one of the following criteria:
- Habitual stool form of Bristol stool type 1-4 or
- ≤4 defecations per week
- living in the surroundings of wageningen (max. 50km)
- in possession of a computer with chrome browser and a mobile phone compatible with applications Note: these criteria are less stringent than the official "constipation" definition, because we preferably want to include participants that do not use laxatives (yet), and we assume that in this 'mild constipation' group increasing fiber intake can have the most beneficial effects. Moreover, we chose not to use the Rome IV criteria as definition of constipation-related complaints, due to the proven inability to distinguish functional constipation from Irritable Bowel Syndrome. If there are sufficient eligible participants, the participants with the lowest stool frequency will be selected
- Relatively low fiber intake (females \<26 grams, males \<33 grams). When enough eligible participants are available, we will choose the participants with the lowest dietary fiber intake.
- signed informed consent
Exclusion
- Subjects with a disease that may interfere with the personal dietary advice or outcomes, such as a known autonomic disorder, inflammatory bowel disease, coeliac disease, cancer, dialysis patients, chronic kidney failure, depression or hypothyroidism.
- Currently following strict diet and unwilling or unable to change; for example a gluten free diet or a "crash diet" using meal substitutes
- Use of medication that can interfere with the study outcomes, including diuretics, antidepressants, codeine, antibiotics or fiber supplements. Preferably laxative use is excluded, but if recruitment is hurdled by this, we at least exclude specific laxatives like resolor, relistor and constella. These are laxatives who have a significant impact on bowel movements, and are only available on prescription. Osmotic (over the counter available) laxatives will be included if recruitment is difficult. Subjects will then be asked to keep their laxative use stable or reduce, but not to increase usage from their habitual pattern (unless necessary, but then report it to the researchers). Moreover, additional questions regarding laxative usage will be included to estimate the effect of laxatives on stool pattern.
- Female subjects: currently pregnant or breastfeeding, or intending to become pregnant during the study, as this can affect stool patterns and wellbeing.
- Are simultaneously participating in another study.
- Unwilling or unable to fulfil the study criteria.
- Student or employee working at Food, Health and Consumer Research from Food and Biobased Research, or Department of Human Nutrition \& Health, Wageningen University.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04457791
Start Date
August 31 2020
End Date
November 2 2020
Last Update
January 22 2021
Active Locations (1)
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1
Wageningen University & Research
Wageningen, Netherlands, 6700AA