Sex Differences in Metabolism Following a High-fat Meal

NCT05332301 | Recruiting

• 1 other identifier: 14714
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

glucose metabolism; lipid metabolism; substrate oxidation

Outcome Measures

Primary Outcomes (4)

• Plasma insulin

  Peak postprandial concentration and/or area under the curve

  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

  Peak postprandial concentration and/or area under the curve

  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

  Peak postprandial concentration and/or area under the curve

  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

  Peak postprandial concentration and/or area under the curve

  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

Secondary Outcomes (4)

• Plasma triglycerides

  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 cholesterols (total and HDL)

  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 non-esterified fatty acids

  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

• Respiratory exchange ratio (RER)

  Will be measured using indirect calorimetry and a facemask at -10 to 0 minutes (fasting), and 50-60 minutes, 110-120 minutes, 170-180 minutes and 230-240 minutes post-ingestion of a high-fat meal.

Study Arms (1)

High-fat test meal

EXPERIMENTAL

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).

Other: High-fat test meal

Interventions

High-fat test meal OTHER

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

High-fat test 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)
• 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)

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

Sponsors & Collaborators

• Kirsten Bell: lead
• McMaster University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (10)

• Whytock KL, Parry SA, Turner MC, Woods RM, James LJ, Ferguson RA, Stahlman M, Boren J, Strauss JA, Cocks M, Wagenmakers AJM, Hulston CJ, Shepherd SO. A 7-day high-fat, high-calorie diet induces fibre-specific increases in intramuscular triglyceride and perilipin protein expression in human skeletal muscle. J Physiol. 2020 Mar;598(6):1151-1167. doi: 10.1113/JP279129. Epub 2020 Feb 14.

  PMID: 31958145 BACKGROUND

• Bachmann OP, Dahl DB, Brechtel K, Machann J, Haap M, Maier T, Loviscach M, Stumvoll M, Claussen CD, Schick F, Haring HU, Jacob S. Effects of intravenous and dietary lipid challenge on intramyocellular lipid content and the relation with insulin sensitivity in humans. Diabetes. 2001 Nov;50(11):2579-84. doi: 10.2337/diabetes.50.11.2579.

  PMID: 11679437 BACKGROUND

• Lundsgaard AM, Fritzen AM, Sjoberg KA, Kleinert M, Richter EA, Kiens B. Small Amounts of Dietary Medium-Chain Fatty Acids Protect Against Insulin Resistance During Caloric Excess in Humans. Diabetes. 2021 Jan;70(1):91-98. doi: 10.2337/db20-0582. Epub 2020 Oct 29.

  PMID: 33122393 BACKGROUND

• Chiu CH, Yang TJ, Chen CH, Zeng MJ. High fat meals increases postprandial fat oxidation rate but not postprandial lipemia. Lipids Health Dis. 2019 Oct 23;18(1):182. doi: 10.1186/s12944-019-1129-x.

  PMID: 31647036 BACKGROUND

• Ando T, Nakae S, Usui C, Yoshimura E, Nishi N, Takimoto H, Tanaka S. Effect of diurnal variations in the carbohydrate and fat composition of meals on postprandial glycemic response in healthy adults: a novel insight for the second-meal phenomenon. Am J Clin Nutr. 2018 Aug 1;108(2):332-342. doi: 10.1093/ajcn/nqy086.

  PMID: 29924301 BACKGROUND

• Parry SA, Turner MC, Woods RM, James LJ, Ferguson RA, Cocks M, Whytock KL, Strauss JA, Shepherd SO, Wagenmakers AJM, van Hall G, Hulston CJ. High-Fat Overfeeding Impairs Peripheral Glucose Metabolism and Muscle Microvascular eNOS Ser1177 Phosphorylation. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz018. doi: 10.1210/clinem/dgz018.

  PMID: 31513265 BACKGROUND

• Whytock KL, Shepherd SO, Cocks M, Wagenmakers AJM, Strauss JA. Young, healthy males and females present cardiometabolic protection against the detrimental effects of a 7-day high-fat high-calorie diet. Eur J Nutr. 2021 Apr;60(3):1605-1617. doi: 10.1007/s00394-020-02357-3. Epub 2020 Aug 13.

  PMID: 32789769 BACKGROUND

• Alayón, A. N. et al. Impacto metabólico e inflamatorio de una comida rica en grasas saturadas y su relación con la obesidad abdominal. Biomédica 38, 100-107, doi:10.7705/biomedica.v38i0.3911 (2017).

  BACKGROUND

• Wang F, Lu H, Liu F, Cai H, Xia H, Guo F, Xie Y, Huang G, Miao M, Shu G, Sun G. Consumption of a liquid high-fat meal increases triglycerides but decreases high-density lipoprotein cholesterol in abdominally obese subjects with high postprandial insulin resistance. Nutr Res. 2017 Jul;43:82-88. doi: 10.1016/j.nutres.2017.05.010. Epub 2017 May 17.

  PMID: 28673468 BACKGROUND

• Obeid R, Awwad HM, Knell AI, Hubner U, Geisel J. Glucose and Fat Tolerance Tests Induce Differential Responses in Plasma Choline Metabolites in Healthy Subjects. Nutrients. 2018 Sep 1;10(9):1209. doi: 10.3390/nu10091209.

  PMID: 30200465 BACKGROUND

Study Officials

• Kirsten E Bell, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten E Bell, PhD

CONTACT

905-525-9140; bellke3@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 18, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)