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Enrolling by Invitation

NCT Number: NCT06921811

Bioavailability From Chickpea Meals in Ileostomists?

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, N.Ireland, BT52 1SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intact chickpeas

Other

Salad meal containing intact chickpeas

Broken chickpeas

Other

Burger meal containing chickpea flour

Primary outcomes

  1. Ileal fluid energy content

    Time frame: Change over 8 hours comparison between treatments

    Energy content calculated by dry matter (g/100g dry basis)

Secondary outcomes

  1. Ileal fluid macronutrient content

    Time frame: Change over 8 hours comparison between treatments

    Measured by dry matter (g/100g dry basis)

  2. Ileal fluid alkylresorcinol content

    Time frame: Change over 8 hours comparison between treatments

    Measured by Mass Spec

  3. Ileal fluid carotenoid content

    Time frame: Change over 8 hours comparison between treatments

    Measured by Mass Spec

  4. Circulating glucose concentration

    Time frame: Change over 8 hours comparison between treatments

    Blood concentrations of glucose using glucometer

  5. Urinary phenolic content

    Time frame: Change over 8 hours comparison between treatments

    Phenolic concentration e.g. hippuric acid in urine

  6. Circulating insulin, levels

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  7. Circulating essential amino acid levels

    Time frame: Change over 8 hours comparison between treatments

    Blood concentrations of amino acids

  8. Circulating triglyceride levels

    Time frame: Change over 8 hours comparison between treatments

  9. Circulating levels of GLP-1

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  10. Circulating levels of GIP

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  11. Circulating levels of ghrelin

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  12. Circulating levels of CKK

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  13. Circulating levels of leptin

    Time frame: Change over 8 hours comparison between treatments

    Measured by ELISA in μg/mL.

  14. Circulating levels of bioactive peptides

    Time frame: Change over 8 hours comparison between treatments

    Blood concentrations of legume bioactives

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Wageningen University and Research

Registry information

Official study title

Bioavailability of Macronutrients and Bioactive Compounds From Chickpea Meals: an Ileostomy Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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