AFDR: Dose Response Relationship Between Fat Ingestion and Metabolism

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05906342

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Tolerance Impaired	Other: 20% fat meal Other: 40% fat meal Other: 60% fat meal Other: 80% fat meal	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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 mealsEach 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:

Double (Participant, Investigator)

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.

Primary Purpose:

Basic Science

Official Title:

Investigating the Effect of Acute Fat Ingestion on Glucose Metabolism in Young Healthy Adults: a Dose Response Study

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20% fat meal This meal will contain 15 kcal/kg of body weight and consist of 20% fat, 65% carbohydrates, and 15% protein.	Other: 20% fat meal Provided to participants once throughout duration of study, contains 20% fat
Experimental: 40% fat meal This meal will contain 15 kcal/kg of body weight and consist of 40% fat, 45% carbohydrates, and 15% protein.	Other: 40% fat meal Provided to participants once throughout duration of study, contains 40% fat
Experimental: 60% fat meal This meal will contain 15 kcal/kg of body weight and consist of 60% fat, 25% carbohydrates, and 15% protein.	Other: 60% fat meal Provided to participants once throughout duration of study, contains 60% fat
Experimental: 80% fat meal This meal will contain 15 kcal/kg of body weight and consist of 80% fat, 5% carbohydrates, and 15% protein.	Other: 80% fat meal Provided to participants once throughout duration of study, contains 80% fat

Outcome Measures

Primary Outcome Measures

Glucose tolerance [Two hours (taking place following the 4-hour postprandial period)]
A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption

Secondary Outcome Measures

Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of glucose (mM)
Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of insulin (µIU/mL)
Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of total cholesterol (mmol/L)
Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of low-density lipoprotein (mmol/L)
Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of high-density lipoprotein (mmol/L)
Glucose and lipid metabolites [During the 4-hour postprandial period]
Postprandial availability of non-esterified fatty acids (mmol/L)

Other Outcome Measures

Hunger hormones [During the 4-hour postprandial period]
Postprandial concentration of ghrelin (pmol/L)
Hunger hormones [During the 4-hour postprandial period]
Postprandial concentration of leptin (pmol/L)
Hunger hormones [During the 4-hour postprandial period]
Postprandial concentration of adiponectin (pmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kirsten Bell, Principal Investigator, McMaster University

ClinicalTrials.gov Identifier:

NCT05906342

Other Study ID Numbers:

16153

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kirsten Bell, Principal Investigator, McMaster University

Additional relevant MeSH terms:

Glucose Intolerance

Study Results

No Results Posted as of Jun 15, 2023