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Completed

NCT Number: NCT03424187

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chickpea

Dietary Supplement

all three meals are isocaloric but different in the chickpea structure( physical form):

  • Whole chickpea, flour chickpea, intact cell flour chickpea

Primary outcomes

  1. Post-prandial Glucose Concentrations

    Time frame: 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

  2. Post-prandial Blood Insulin Concentrations

    Time frame: 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.

Secondary outcomes

  1. Post-prandial Gut Hormone Gastric Inhibitory Polypeptide (GIP)

    Time frame: 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

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

    Time frame: 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.

  3. Energy Intake at a Meal Given in Excess

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Feb 6, 2018
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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