The Acute Effects of Food Structure on Post Prandial Glucose and Subsequent Metabolic Responses

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: chickpea

Detailed Description

Rationale:

There is very little evidence at the present time in the role of food structure in glucose homeostasis. There is circumstantial evidence that foods consumed intact have great effects on suppressing appetite.

To test the effect of three structurally different meals with the same nutritional content and volume on appetite regulation. Each participant will receive the following meals:

Solid meal group. Milled (intact-cell) meal group. Milled (destroyed-cell) meal group.

All of which will contain the same macro and micro nutrients from the same food sources

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gender: male and female
• Age ≥ 18 years ≤ 65 years
• Normal weight as classified by BMI 20-29.9 kg/m2
• Healthy, not diagnosed with any chronic diseases assessed as appropriate for inclusion, based on the pre-study screening.
• Willingness and ability to understand, participate and to comply with the study requirements
• Willingness and ability to give written informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole chickpea; a test meal containing 26g available carbohydrates from chickpea (full structure)	Dietary supplement: chickpea; all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea
Experimental: flour chickpea; a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)	Dietary supplement: chickpea; all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea
Experimental: intact cell chickpea; a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)	Dietary supplement: chickpea; all three meals are isocaloric but different in the chickpea structure( physical form): • Whole chickpea, flour chickpea, intact cell flour chickpea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)	Blood GIP concentrations were assessed for each participant after each test meal: whole chickpea hummus, and Flour 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 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)	Blood GLP-1 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.	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	The difference in ad libitum food intake after 210 minutes post test meal to test the difference of energy intake following whole chickpea hummus, flour chickpea hummus, and intact cell chickpea hummus.	post consumption of the test meal at 120 minutes

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 15HH3069