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Dose Response Relationship Between Fat Ingestion and Metabolism (AFDR)

Primary Purpose

Glucose Tolerance Impaired

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
20% fat meal
40% fat meal
60% fat meal
80% fat meal
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Tolerance Impaired focused on measuring High-fat, Glucose, Insulin, Metabolism, Nutrition

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI between 18.5 and 30.0 kg/m2 Weight stable for the past 6 months (± 2kg) VO2max values within a below average to above average range (38-50 mL/kg and 35-47 mL/kg for 18-25 year old males and females respectively. 35-48 mL/kg and 34-45 mL/kg for 26-35 year old males and females respectively) Fasting blood glucose <6.0 mM Resting blood pressure <140/90 mmHg Taking second generation oral contraceptives (females only) Exclusion Criteria: Smoking Diabetes, cancer, or other metabolic disorders Cardiac or gastrointestinal problems Infectious disease Barium swallow or nuclear medicine scan in the previous 3 weeks Follow a strict vegan diet Pregnant or breastfeeding (females only) Diagnosis of polycystic ovary syndrome (females only)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    20% fat meal

    40% fat meal

    60% fat meal

    80% fat meal

    Arm Description

    This meal will contain 15 kcal/kg of body weight and consist of 20% fat, 65% carbohydrates, and 15% protein.

    This meal will contain 15 kcal/kg of body weight and consist of 40% fat, 45% carbohydrates, and 15% protein.

    This meal will contain 15 kcal/kg of body weight and consist of 60% fat, 25% carbohydrates, and 15% protein.

    This meal will contain 15 kcal/kg of body weight and consist of 80% fat, 5% carbohydrates, and 15% protein.

    Outcomes

    Primary Outcome Measures

    Glucose tolerance
    A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption

    Secondary Outcome Measures

    Glucose and lipid metabolites
    Postprandial availability of glucose (mM)
    Glucose and lipid metabolites
    Postprandial availability of insulin (µIU/mL)
    Glucose and lipid metabolites
    Postprandial availability of total cholesterol (mmol/L)
    Glucose and lipid metabolites
    Postprandial availability of low-density lipoprotein (mmol/L)
    Glucose and lipid metabolites
    Postprandial availability of high-density lipoprotein (mmol/L)
    Glucose and lipid metabolites
    Postprandial availability of non-esterified fatty acids (mmol/L)

    Full Information

    First Posted
    March 11, 2023
    Last Updated
    June 14, 2023
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05906342
    Brief Title
    Dose Response Relationship Between Fat Ingestion and Metabolism
    Acronym
    AFDR
    Official Title
    Investigating the Effect of Acute Fat Ingestion on Glucose Metabolism in Young Healthy Adults: a Dose Response Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare features of metabolism in healthy, young adults after they consume four meals of differing fat quantity. The main question this trial aims to answer is how does increasing fat quantity impact glucose tolerance, glucose and insulin metabolism, and hormones involved in hunger. Participant will consume four meals consisting of either 20, 40, 60, or 80% energy from fat.
    Detailed Description
    The long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. Similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. Comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. Therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Tolerance Impaired
    Keywords
    High-fat, Glucose, Insulin, Metabolism, Nutrition

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Each participant will be required to consume four breakfast meals (containing 20, 40, 60, or 80% energy from fat) in a randomized order with a washout period between meals
    Masking
    ParticipantInvestigator
    Masking Description
    Participants and investigators will not know the fat quantity of the meal that is being consumed or the order in which the meals are provided to the participant. A non-investigator member of the research team will be responsible for creating the meals and keeping track of which meals are being consumed.
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    20% fat meal
    Arm Type
    Experimental
    Arm Description
    This meal will contain 15 kcal/kg of body weight and consist of 20% fat, 65% carbohydrates, and 15% protein.
    Arm Title
    40% fat meal
    Arm Type
    Experimental
    Arm Description
    This meal will contain 15 kcal/kg of body weight and consist of 40% fat, 45% carbohydrates, and 15% protein.
    Arm Title
    60% fat meal
    Arm Type
    Experimental
    Arm Description
    This meal will contain 15 kcal/kg of body weight and consist of 60% fat, 25% carbohydrates, and 15% protein.
    Arm Title
    80% fat meal
    Arm Type
    Experimental
    Arm Description
    This meal will contain 15 kcal/kg of body weight and consist of 80% fat, 5% carbohydrates, and 15% protein.
    Intervention Type
    Other
    Intervention Name(s)
    20% fat meal
    Intervention Description
    Provided to participants once throughout duration of study, contains 20% fat
    Intervention Type
    Other
    Intervention Name(s)
    40% fat meal
    Intervention Description
    Provided to participants once throughout duration of study, contains 40% fat
    Intervention Type
    Other
    Intervention Name(s)
    60% fat meal
    Intervention Description
    Provided to participants once throughout duration of study, contains 60% fat
    Intervention Type
    Other
    Intervention Name(s)
    80% fat meal
    Intervention Description
    Provided to participants once throughout duration of study, contains 80% fat
    Primary Outcome Measure Information:
    Title
    Glucose tolerance
    Description
    A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption
    Time Frame
    Two hours (taking place following the 4-hour postprandial period)
    Secondary Outcome Measure Information:
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of glucose (mM)
    Time Frame
    During the 4-hour postprandial period
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of insulin (µIU/mL)
    Time Frame
    During the 4-hour postprandial period
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of total cholesterol (mmol/L)
    Time Frame
    During the 4-hour postprandial period
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of low-density lipoprotein (mmol/L)
    Time Frame
    During the 4-hour postprandial period
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of high-density lipoprotein (mmol/L)
    Time Frame
    During the 4-hour postprandial period
    Title
    Glucose and lipid metabolites
    Description
    Postprandial availability of non-esterified fatty acids (mmol/L)
    Time Frame
    During the 4-hour postprandial period
    Other Pre-specified Outcome Measures:
    Title
    Hunger hormones
    Description
    Postprandial concentration of ghrelin (pmol/L)
    Time Frame
    During the 4-hour postprandial period
    Title
    Hunger hormones
    Description
    Postprandial concentration of leptin (pmol/L)
    Time Frame
    During the 4-hour postprandial period
    Title
    Hunger hormones
    Description
    Postprandial concentration of adiponectin (pmol/L)
    Time Frame
    During the 4-hour postprandial period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: BMI between 18.5 and 30.0 kg/m2 Weight stable for the past 6 months (± 2kg) VO2max values within a below average to above average range (38-50 mL/kg and 35-47 mL/kg for 18-25 year old males and females respectively. 35-48 mL/kg and 34-45 mL/kg for 26-35 year old males and females respectively) Fasting blood glucose <6.0 mM Resting blood pressure <140/90 mmHg Taking second generation oral contraceptives (females only) Exclusion Criteria: Smoking Diabetes, cancer, or other metabolic disorders Cardiac or gastrointestinal problems Infectious disease Barium swallow or nuclear medicine scan in the previous 3 weeks Follow a strict vegan diet Pregnant or breastfeeding (females only) Diagnosis of polycystic ovary syndrome (females only)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kirsten E Bell, Ph.D.
    Phone
    905 525 9140
    Ext
    24872
    Email
    bellke3@mcmaster.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be available to other researchers

    Learn more about this trial

    Dose Response Relationship Between Fat Ingestion and Metabolism

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