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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: chickpea

• Registration Number: NCT03424187
• Lead Sponsor: Imperial College London

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.

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-05
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Study Completion: 2018-07
• Results First Submitted: 2020-07-07
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Results First Posted: 2021-04-02
• Last Update Posted: 2021-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
whole chickpea	chickpea	a test meal containing 26g available carbohydrates from chickpea (full structure)
flour chickpea	chickpea	a test meal containing 26g available carbohydrates from flour chickpea (destroyed structure)
intact cell chickpea	chickpea	a test meal containing 26g available carbohydrates from intact cell chickpea flour (full structure)

Primary Outcome Measures

Name	Time	Method
Post-prandial Blood Insulin Concentrations	before the consumption of the test meal and then 15, 30, 60, 90, 120, and 180 minutes post consumption of test meal.	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.
Post-prandial Glucose Concentrations	before the consumption of the test meal and then 15 min, 30, 60,90, 120, 180 minutes after the consumption of the test meal.	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

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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
Energy Intake at a Meal Given in Excess	post consumption of the test meal at 120 minutes	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.