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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424187
• Other study ID #: 15HH3069
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: March 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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