NCT06921811

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 10, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

March 25, 2025

Last Update Submit

April 3, 2025

Conditions

NutritionAbsorptionPolyphenolic Compounds and MetabolismPolyphenols Absorption ProfileEnergy Availability

Keywords

Food structureCell wallsMacronutrientsChickpeasBioactive compounds

Outcome Measures

Primary Outcomes (1)

  • Ileal fluid energy content

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

    Change over 8 hours comparison between treatments

Secondary Outcomes (14)

  • Ileal fluid macronutrient content

    Change over 8 hours comparison between treatments

  • Ileal fluid alkylresorcinol content

    Change over 8 hours comparison between treatments

  • Ileal fluid carotenoid content

    Change over 8 hours comparison between treatments

  • Circulating glucose concentration

    Change over 8 hours comparison between treatments

  • Urinary phenolic content

    Change over 8 hours comparison between treatments

  • +9 more secondary outcomes

Study Arms (2)

INTACT meal

EXPERIMENTAL
Other: Intact chickpeas

BROKEN meal

EXPERIMENTAL
Other: Broken chickpeas

Interventions

Intact chickpeasOTHER

Salad meal containing intact chickpeas

INTACT meal
Broken chickpeasOTHER

Burger meal containing chickpea flour

BROKEN meal

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Never had an ileostomy
  • \<1.5-year post-operative
  • Not aged 18-60 years
  • Pregnant/lactating female
  • Smokers
  • Allergic to nuts and celery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Intervention Studies Unit, Ulster University

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

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised single-blind crossover trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 10, 2025

Study Start

April 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)