Status:
UNKNOWN
Physiological, Microbiological and Metabolomic Effects of Fruit Products
Lead Sponsor:
King's College London
Collaborating Sponsors:
Queen Mary University of London
Imperial College London
Conditions:
Constipation - Functional
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effe...
Eligibility Criteria
Inclusion
- Men and women aged 18-65 years.
- Individuals meeting the Rome IV criteria for functional constipation, in addition to having \<7 bowel movements per week and hard or lumpy stools present in ⩾25% of their defecations (defined as Type 1 \& 2 of the Bristol Stool Form Scale).
- Individuals who are willing to consume fruit products for 4 weeks.
- Individuals who consume \<30g of fibre per day
- Individuals with a BMI of 18.5-29.99 kg/m2.
- Individuals able to give informed consent.
Exclusion
- Females who report to be pregnant or lactating.
- Regular consumers of the fruit products used in the intervention arm 1 (3 or more portions per week).
- Allergy, intolerance or dislike of the fruit products used in this intervention.
- Sulphite allergy or sensitivity.
- Ongoing alcohol, drug or medication abuse.
- Major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy, appendicectomy and haemorrhoidectomy.
- Medications which affect their gut physiology, function and symptoms in the last 4 weeks, and individuals who are not willing or cannot discontinue them.
- Frequent use of rescue laxatives.
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04086134
Start Date
October 25 2019
End Date
March 31 2022
Last Update
June 22 2021
Active Locations (1)
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1
King's College London
London, United Kingdom, SE1 9NH