Recruiting

Observational Study

Sponsor:

Kirsten Bell

Code:

NCT05332301

Conditions

Healthy Nutrition

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

High-fat test meal

Study Details

Brief summary:

Long-term consumption (i.e., several weeks to months) of a diet that is high in fat (>35% daily calories from fat) is associated with the development of insulin resistance, a condition that can lead to a diagnosis of type 2 diabetes. Women tend to be better protected against the development of high-fat diet-induced insulin resistance compared with men, but it is not fully understand why this sex difference exists. It is possible that women metabolize high-fat meals differently than men, which might explain why they are less likely to develop type 2 diabetes over the course of their lifetime. However, no one has ever compared the metabolic response to a high-fat meal between men and women in the hours immediately after ingestion.

During this study, the investigators will administer a single high-fat "fast-food" style breakfast meal (846 kcal, of which 58% is fat) to 24 health young adults (n=12 men, n=12 women) 18-35 years old. Their objective is to determine whether there are differences in the way men and women metabolize high-fat meals, such as this one. The research team will take regular blood samples after participants ingest this meal to measure features of glucose metabolism (e.g., blood glucose and insulin) as well as resting oxygen uptake (VO2) measurements to examine how much of this meal is burned for energy in the hours immediately after ingestion.

Conditions

Healthy Nutrition

Study ID

NCT05332301

Start date

Oct 4, 2022

Status verified date

Aug, 2025

Completion date

May 30, 2027

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • BMI between 18.5 and 30.0 kg/m2
  • Weight stable for the past 6 months (± 2kg)
  • Exercise at or below the Canadian Physical Activity Guidelinesa
  • Fasting blood glucose <6.0 mM
  • Resting blood pressure <140/90 mmHg
  • No hormone-altering contraceptive use (e.g., pill, patch, ring, injection)

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
  • Pregnant or breastfeeding
  • Diagnosis of polycystic ovary syndrome
  • Follow a vegan or vegetarian diet
  • Not fully vaccinated against COVID19

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High-fat test meal

All participants will consume a high-fat breakfast after an overnight fast. This meal will consist of a flour tortilla, eggs, bacon, cheddar cheese, mayonnaise, and hashbrowns. After the initial blood sample (0 min) is drawn during Visit 2, we will ask participants to consume this breakfast within 10 minutes. This meal has been designed to mimic the amount of energy (calories) and fat contained in a typical fast-food breakfast (e.g., from Tim Hortons or McDonalds). Each meal will provide 846 kcal, derived from 54 g fat (58% energy), 61 g carbohydrate (29% energy), and 29 g protein (13% energy).

Interventions

High-fat test meal

Ingestion of a mixed macronutrient breakfast meal providing 846 kcal, of which 58% is fat, 29% is carbohydrate and 13% is protein.

Primary outcome measure

  • Plasma insulin [ Time Frame: Will be measured in blood samples taken at 0 minutes (fasting), and 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes post-ingestion of a high-fat meal ]
  • Plasma glucose [ Time Frame: Will be measured in blood samples taken at 0 minutes (fasting), and 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes post-ingestion of a high-fat meal ]
  • Plasma c-peptide [ Time Frame: Will be measured in blood samples taken at 0 minutes (fasting), and 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes post-ingestion of a high-fat meal ]
  • Plasma glucagon [ Time Frame: Will be measured in blood samples taken at 0 minutes (fasting), and 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes post-ingestion of a high-fat meal ]

Central Contacts and Locations

Central contacts

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

Contacts

More Information

Sponsor

Kirsten Bell

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • glucose metabolism
  • lipid metabolism
  • substrate oxidation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kirsten Bell on 2025-08-19.