Laxative Properties of Microencapsulated Lipid (Constipation Study)
A Proof of Principle Study of the Laxative Properties of Microencapsulated Lipid in Patients Experiencing Constipation Related to Intentional Weight Loss
1 other identifier
interventional
31
1 country
1
Brief Summary
The present study seeks to build on these observations to assess whether in principle, fat containing microcapsules might help patients experiencing constipation in association with weight loss interventions (including GLP-1 analogues or bariatric surgery) to both avoid/treat constipation and simultaneously optimise their ability to feel full during eating. This potential dual action may provide added benefit versus the use of traditional approaches to constipation prophylaxis e.g., lactulose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2023
CompletedMay 31, 2022
May 1, 2022
1 year
April 4, 2022
May 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Completed bowel motion
Proportion of participants reporting a completed bowel motion within 24 hours.
24 hours
Secondary Outcomes (4)
Hunger
6 hours
calories
6 hours
Gut hormones
6 hours
Fullness
6 hours
Study Arms (2)
Microencapsulated fat stomach
EXPERIMENTALParticipants will consume a drink containing 400kcal of microencapsulated fat that will be released in the stomach.
Microencapsulated fat intestine
EXPERIMENTALParticipants will consume a drink containing 400kcal of microencapsulated fat that will be released in the intestine.
Interventions
Consumption of a drink that contains microencapsulated fat that will be released either in the stomach or in the distal small intestines.
Eligibility Criteria
You may qualify if:
- years
- Engaged in weight loss treatment
- Diagnosis of chronic constipation (Rome IV criteria)1
- Capacity to consent to participate
You may not qualify if:
- Substance abuse
- Pregnancy
- Patients who are taking medication for constipation should be on stable doses of medications for constipation for more than 2 weeks. They should neither start nor stop any medication for constipation in the 2 weeks prior to the visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Centre
Dublin, Dublin 4, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carel le Roux
University College Dublin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2022
First Posted
April 12, 2022
Study Start
April 15, 2022
Primary Completion
April 15, 2023
Study Completion
April 15, 2023
Last Updated
May 31, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share