Dose Response Relationship Between Fat Ingestion and Metabolism

NCT05906342 | Completed

• 1 other identifier: 16153
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Tolerance Impaired

Keywords

High-fat; Glucose; Insulin; Metabolism; Nutrition

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance

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

  Two hours (taking place following the 4-hour postprandial period)

Secondary Outcomes (6)

• Glucose and lipid metabolites

  During the 4-hour postprandial period

• Glucose and lipid metabolites

  During the 4-hour postprandial period

• Glucose and lipid metabolites

  During the 4-hour postprandial period

• Glucose and lipid metabolites

  During the 4-hour postprandial period

• Glucose and lipid metabolites

  During the 4-hour postprandial period

Other Outcomes (3)

• Hunger hormones

  During the 4-hour postprandial period

• Hunger hormones

  During the 4-hour postprandial period

• Hunger hormones

  During the 4-hour postprandial period

Study Arms (4)

20% fat meal

EXPERIMENTAL

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

Other: 20% fat meal

40% fat meal

EXPERIMENTAL

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

Other: 40% fat meal

60% fat meal

EXPERIMENTAL

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

Other: 60% fat meal

80% fat meal

EXPERIMENTAL

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

Other: 80% fat meal

Interventions

20% fat meal OTHER

Provided to participants once throughout duration of study, contains 20% fat

20% fat meal

40% fat meal OTHER

Provided to participants once throughout duration of study, contains 40% fat

40% fat meal

60% fat meal OTHER

Provided to participants once throughout duration of study, contains 60% fat

60% fat meal

80% fat meal OTHER

Provided to participants once throughout duration of study, contains 80% fat

80% fat meal

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, L8S 3X3, Canada

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: June 15, 2023
• Study Start: July 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)