NCT03424187

Brief Summary

Aims: To investigate the effects of different food structures on glucose concentrations and subsequent metabolic responses including insulin,GIP, GLP-1 DESIGN: A randomised, controlled, clinical trial.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2016

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 2, 2021

Completed
Last Updated

April 2, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

September 1, 2017

Results QC Date

July 7, 2020

Last Update Submit

March 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Post-prandial Glucose Concentrations

    Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal. Data were not collected for intact cell chickpea hummus

    before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.

  • Post-prandial Blood Insulin Concentrations

    Blood glucose concentrations were assessed for each participant after each test meal: whole chickpea hummus, Flour chickpea hummus, and Intact cell chickpea hummus. Blood samples were collected before the introduction of the test meal and then at 15 minutes, 30 min, 60, 90, 120, and 180 minutes after the consumption of the test meal.

    before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.

Secondary Outcomes (3)

  • Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)

    before the consumption of the test meal at 0 min and then post test meal at 15, 30,60 ,90,120 and 180 minutes.

  • Post-prandial Gut Hormone Glucagon-like Peptide 1 (GLP-1)

    baseline before the consumption of the test meal, and then 15,30,60,90,120,180 min after the consumption of the test meal.

  • Energy Intake at a Meal Given in Excess

    post consumption of the test meal at 120 minutes

Study Arms (3)

whole chickpea

EXPERIMENTAL

a test meal containing 26g available carbohydrates from chickpea (full structure)

Dietary Supplement: chickpea

flour chickpea

EXPERIMENTAL

a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)

Dietary Supplement: chickpea

intact cell chickpea

EXPERIMENTAL

a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)

Dietary Supplement: chickpea

Interventions

chickpeaDIETARY_SUPPLEMENT

all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea

flour chickpeaintact cell chickpeawhole chickpea

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender: male and female
  • Age ≥ 18 years ≤ 65 years
  • Normal weight as classified by BMI 20-29.9 kg/m2
  • Willingness and ability to understand, participate and to comply with the study requirements
  • Willingness and ability to give written informed consent

You may not qualify if:

  • Has thyroid defects
  • Under hormone or steroids therapy
  • Is pregnant or lactating (female)
  • Had given birth within the past year (female)
  • Is taking drugs that could affect appetite or plasma glucose levels.
  • Is taking natural remedies that modulate appetite or plasma glucose levels.
  • Has excessive alcohol intake
  • Had blood donation within 12wks prior to start date
  • Psychiatric illness
  • Smokers
  • History of any disease with unknown outcome
  • Has diabetes
  • Has nut allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alshaalan RA, Charalambides MN, Edwards CH, Ellis PR, Alrabeah SH, Frost GS. Impact of chickpea hummus on postprandial blood glucose, insulin and gut hormones in healthy humans combined with mechanistic studies of food structure, rheology and digestion kinetics. Food Res Int. 2024 Jul;188:114517. doi: 10.1016/j.foodres.2024.114517. Epub 2024 May 10.

MeSH Terms

Conditions

Obesity

Interventions

cicerin protein, Cicer arietinum

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gary Frost
Organization
Imperial College London

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2017

First Posted

February 6, 2018

Study Start

July 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2018

Last Updated

April 2, 2021

Results First Posted

April 2, 2021

Record last verified: 2021-03