NutritionNCT06921811
Bioavailability From Chickpea Meals in Ileostomists?
A study testing Intact chickpeas and Broken chickpeas in people with Nutrition and Absorption, run by University of Ulster at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Absorption, Polyphenolic Compounds and Metabolism
- What is being tested?
- Intact chickpeas and Broken chickpeas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Never had an ileostomy
- <1.5-year post-operative
- Not aged 18-60 years
- Pregnant/lactating female
- Smokers
- Allergic to nuts and celery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, N.Ireland, BT52 1SA
About this study
Official title: 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).
Read the 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.
- Conditions
- Nutrition, Absorption, Polyphenolic Compounds and Metabolism, Polyphenols Absorption Profile, Energy Availability
- Being tested
- Intact chickpeas, Broken chickpeas
- Keywords
- Food structure, Cell walls, Macronutrients, Chickpeas, Bioactive compounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intact chickpeasOther
Salad meal containing intact chickpeas
Broken chickpeasOther
Burger meal containing chickpea flour
| Study group | Role | What they receive |
|---|---|---|
| INTACT meal | Experimental | Not described Receives: Other: Intact chickpeas |
| BROKEN meal | Experimental | Not described Receives: Other: Broken chickpeas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ileal fluid energy content
Energy content calculated by dry matter (g/100g dry basis)
Measured: Change over 8 hours comparison between treatments
Secondary outcomes (14)
Ileal fluid macronutrient content
Measured by dry matter (g/100g dry basis)
Measured: Change over 8 hours comparison between treatments
Ileal fluid alkylresorcinol content
Measured by Mass Spec
Measured: Change over 8 hours comparison between treatments
Ileal fluid carotenoid content
Measured by Mass Spec
Measured: Change over 8 hours comparison between treatments
Circulating glucose concentration
Blood concentrations of glucose using glucometer
Measured: Change over 8 hours comparison between treatments
Urinary phenolic content
Phenolic concentration e.g. hippuric acid in urine
Measured: Change over 8 hours comparison between treatments
Circulating insulin, levels
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating essential amino acid levels
Blood concentrations of amino acids
Measured: Change over 8 hours comparison between treatments
Circulating triglyceride levels
Measured: Change over 8 hours comparison between treatments
Circulating levels of GLP-1
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating levels of GIP
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating levels of ghrelin
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating levels of CKK
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating levels of leptin
Measured by ELISA in μg/mL.
Measured: Change over 8 hours comparison between treatments
Circulating levels of bioactive peptides
Blood concentrations of legume bioactives
Measured: Change over 8 hours comparison between treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised single-blind crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Wageningen University and Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921811
- Sponsor's protocol ID
- REC/24/0083
- Status last verified
- Feb 2025
- First submitted
- 25 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Macronutrients and Bioactive Compounds From Chickpea Meals: an Ileostomy Study.
- ClinicalTrials.gov ID
- NCT06921811
- Acronym / sponsor ID
- REC/24/0083
- Conditions
- Nutrition, Absorption, Polyphenolic Compounds and Metabolism, Polyphenols Absorption Profile, Energy Availability
- Keywords
- Food structure, Cell walls, Macronutrients, Chickpeas, Bioactive compounds
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Wageningen University and Research
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised single-blind crossover trial
| Arm | Type | Receives |
|---|---|---|
| INTACT meal | Experimental | Other: Intact chickpeas |
| BROKEN meal | Experimental | Other: Broken chickpeas |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Previously had an ileostomy
- ≥1.5-years post-operative
- Aged 18-60 years
- Males and females (not currently pregnant/lactating)
- Non-smokers
Key exclusion criteria (6 listed)
- Never had an ileostomy
- <1.5-year post-operative
- Not aged 18-60 years
- Pregnant/lactating female
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intact chickpeasSalad meal containing intact chickpeas | Other | INTACT meal |
| Broken chickpeasBurger meal containing chickpea flour | Other | BROKEN meal |
Primary outcome
Ileal fluid energy content
Time frame: Change over 8 hours comparison between treatments
Energy content calculated by dry matter (g/100g dry basis)
14 secondary outcomes
Ileal fluid macronutrient content
Time frame: Change over 8 hours comparison between treatments
Ileal fluid alkylresorcinol content
Time frame: Change over 8 hours comparison between treatments
Ileal fluid carotenoid content
Time frame: Change over 8 hours comparison between treatments
Circulating glucose concentration
Time frame: Change over 8 hours comparison between treatments
Urinary phenolic content
Time frame: Change over 8 hours comparison between treatments
Circulating insulin, levels
Time frame: Change over 8 hours comparison between treatments
Circulating essential amino acid levels
Time frame: Change over 8 hours comparison between treatments
Circulating triglyceride levels
Time frame: Change over 8 hours comparison between treatments
Circulating levels of GLP-1
Time frame: Change over 8 hours comparison between treatments
Circulating levels of GIP
Time frame: Change over 8 hours comparison between treatments
Circulating levels of ghrelin
Time frame: Change over 8 hours comparison between treatments
Circulating levels of CKK
Time frame: Change over 8 hours comparison between treatments
Circulating levels of leptin
Time frame: Change over 8 hours comparison between treatments
Circulating levels of bioactive peptides
Time frame: Change over 8 hours comparison between treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intact chickpeas and Broken chickpeas in people with Nutrition and Absorption, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ileal fluid energy content (time frame: Change over 8 hours comparison between treatments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.