- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06921811
Bioavailability From Chickpea Meals in Ileostomists?
April 3, 2025 updated by: University of Ulster
Bioavailability of Macronutrients and Bioactive Compounds From Chickpea Meals: an Ileostomy Study.
The matrix of a food can significantly affect how well humans can absorb and use nutrients.
Plants like fruits, vegetables, nuts, grains, and legumes have cell walls that form a network around their cells.
These cell walls are a barrier for the digestive system to break down completely, which can make it harder to digest the food and get energy from it.
This study will explore how the integrity of plant cell walls affects how well humans can absorb macronutrients (protein, fat and carbohydrates) and beneficial compounds e.g.
phytochemicals.
The study will compare two chickpea meals that have similar nutrients and energy content but differ in the amount of intact plant cell walls e.g.
chickpea salad meal (INTACT diet) and chickpea burger meal (BROKEN diet).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The energy content of food can be in principle calculated by multiplying the content of each energy-yielding substrate by the corresponding heat of combustion.
However, only part of this energy yielding substrates is converted to energy because of their incomplete digestion and absorption in the gastrointestinal tract.
The structural composition of foods, known as the food matrix, significantly affects nutrient bioavailability.
One such structural feature is the integrity of plant tissues characterised by the interconnected, continuous network of cell walls which surround and protect plant cells.
When cellular integrity is retained, macronutrients are naturally "encapsulated" within cell walls which effectively reduces the rate and the extent of their digestibility by 6-7% compared to a diet poor in plant-based foods.
This study aims to investigate the effect of plant tissue integrity on the total energy excretion of a diet, bioavailability of macronutrients and bioactive compounds, and on plasma levels of glucose, essential amino acids and triglycerides.
The investigators will do this by comparing two diets which have (approximately) the same composition in macronutrients and energy but different levels of plant tissues integrity, namely a diet rich in intact plant tissues (INTACT diet), and a diet poor in such intact plant tissues (BROKEN diet).
The investigators will use an ileostomy model to be able to determine the difference in energy excretion at the level of the terminal ileum.
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
N.Ireland
-
Coleraine, N.Ireland, United Kingdom, BT52 1SA
- Human Intervention Studies Unit, Ulster University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Previously had an ileostomy
- ≥1.5-years post-operative
- Aged 18-60 years
- Males and females (not currently pregnant/lactating)
- Non-smokers
- Not allergic to nuts and celery
Exclusion Criteria:
- Never had an ileostomy
- <1.5-year post-operative
- Not aged 18-60 years
- Pregnant/lactating female
- Smokers
- Allergic to nuts and celery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INTACT meal
|
Salad meal containing intact chickpeas
|
|
Experimental: BROKEN meal
|
Burger meal containing chickpea flour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ileal fluid energy content
Time Frame: Change over 8 hours comparison between treatments
|
Energy content calculated by dry matter (g/100g dry basis)
|
Change over 8 hours comparison between treatments
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ileal fluid macronutrient content
Time Frame: Change over 8 hours comparison between treatments
|
Measured by dry matter (g/100g dry basis)
|
Change over 8 hours comparison between treatments
|
|
Ileal fluid alkylresorcinol content
Time Frame: Change over 8 hours comparison between treatments
|
Measured by Mass Spec
|
Change over 8 hours comparison between treatments
|
|
Ileal fluid carotenoid content
Time Frame: Change over 8 hours comparison between treatments
|
Measured by Mass Spec
|
Change over 8 hours comparison between treatments
|
|
Circulating glucose concentration
Time Frame: Change over 8 hours comparison between treatments
|
Blood concentrations of glucose using glucometer
|
Change over 8 hours comparison between treatments
|
|
Urinary phenolic content
Time Frame: Change over 8 hours comparison between treatments
|
Phenolic concentration e.g.
hippuric acid in urine
|
Change over 8 hours comparison between treatments
|
|
Circulating insulin, levels
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating essential amino acid levels
Time Frame: Change over 8 hours comparison between treatments
|
Blood concentrations of amino acids
|
Change over 8 hours comparison between treatments
|
|
Circulating triglyceride levels
Time Frame: Change over 8 hours comparison between treatments
|
Change over 8 hours comparison between treatments
|
|
|
Circulating levels of GLP-1
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating levels of GIP
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating levels of ghrelin
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating levels of CKK
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating levels of leptin
Time Frame: Change over 8 hours comparison between treatments
|
Measured by ELISA in μg/mL.
|
Change over 8 hours comparison between treatments
|
|
Circulating levels of bioactive peptides
Time Frame: Change over 8 hours comparison between treatments
|
Blood concentrations of legume bioactives
|
Change over 8 hours comparison between treatments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
March 25, 2025
First Submitted That Met QC Criteria
April 3, 2025
First Posted (Actual)
April 10, 2025
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- REC/24/0083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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