Healthy NutritionHFMNCT05332301
Sex Differences in Metabolism Following a High-fat Meal
A study testing High-fat test meal in people with Healthy Nutrition, run by Kirsten Bell at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- High-fat test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 4 Oct 2022to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Diagnosis of polycystic ovary syndrome
- Follow a vegan or vegetarian diet
- Not fully vaccinated against COVID19
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4K1
Kirsten E Bell, PhD, 905-525-9140 ext. 24872, bellke3@mcmaster.ca
About this study
Official title: Exploring Sex Differences in the Acute Postprandial Metabolic Response to a High-fat Mixed Macronutrient Meal Challenge in Healthy Young Humans
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.
Read the detailed description
Long-term high-fat feeding is known to induce insulin resistance and impair whole-body glucose clearance in humans, yet knowledge of the glucose metabolic effects of high-fat feeding remains incomplete. Excess fat consumption leads to elevated circulating concentrations of non-esterified fatty acids (NEFAs), which (when taken up by muscle, an organ vital for glucose homeostasis) may interfere with insulin signaling and glucose disposal.
Despite the relatively rich body of research on high-fat feeding, the acute (i.e., 1-4 hours post-ingestion) effects of a high-fat meal on postprandial glucose metabolism are poorly characterized. Understanding the acute response to high-fat feeding is a key step towards uncovering the mechanisms that drive the development of dietary fat-induced insulin resistance. Limited work suggests that postprandial insulinemia may be elevated in response to a high-fat meal, and that this effect may be more pronounced in individuals with higher adiposity. Previous work has shown that ingestion of a mixed macronutrient meal high in saturated fat (~60% total fat, 32% saturated fat) stimulated significantly greater increases in circulating insulin concentrations in obese compared with lean middle-aged subjects. The effect of acute high-fat feeding on postprandial glycemia is less clear: studies have reported increased, decreased, or no change in glucose concentrations in response to a high-fat challenge. The quantity of fat administered may help explain these conflicting reports: studies have variously employed meals comprising 40%, 60% and up to 80% fat. These discrepancies in the literature may also be underpinned by the inclusion of males and females in the same study.
There is a paucity of data on the glucose metabolic response to high-fat feeding in human females. Although a handful of studies have included female subjects, this may have masked potentially divergent effects of high-fat feeding on glucose metabolism in males compared with females. Generally speaking, females have lower fasting plasma glucose concentrations (indicative of heightened hepatic insulin sensitivity) and are more adept at storing circulating NEFAs as subcutaneous adipose tissue (SAT). Although males have greater skeletal muscle mass (an important glucose reservoir) and lower whole-body adiposity than females, they preferentially accumulate adipose tissue in depots associated with metabolic dysfunction, such as the viscera and skeletal muscle [30]. Indeed, only one study to date has directly compared males and females to show that 7 days of suprarenergetic high-fat feeding (+50% kcal/d, 65% fat) stimulated an increase in trunk fat mass in males, with no discernable body composition changes in females. Given these sex-based differences in insulin sensitivity and adipose tissue storage, it is possible that females exhibit a distinct glucose metabolic response to high-fat feeding compared to males. However, this hypothesis has yet to be fully explored.
Therefore, in this study, the investigators will administer a single high-fat mixed macronutrient meal to a group of healthy young adults. Over the 4-hour postprandial period, they aim to compare the following in females versus males:
- Circulating features of glucose metabolism (primary objective)
- Circulating features of lipid metabolism (secondary objective)
- Energy expenditure and substrate oxidation via indirect calorimetry (tertiary objective)
The investigators hypothesize that, compared with males, females will demonstrate:
- Lower circulating concentrations of glucose, insulin, c-peptide and glucagon
- Lower circulating concentrations of triglycerides, total cholesterol, low-density lipoprotein cholesterol and NEFAs; and higher circulating concentrations of high-density lipoprotein cholesterol
- Greater energy expenditure and fat oxidation, and lower carbohydrate oxidation
This acute nutrition intervention study will involve a total of 3 visits to the laboratory (initial screening visit plus 2 study visits). After a screening visit to assess eligibility, young adults who have consented to participate will report to the laboratory after an overnight on 2 separate occasions: Baseline Assessment (Visit 1) and Nutrition Intervention (Visit 2).
Screening visit: Eligibility will be assessed during a screening session at the laboratory. The investigators will measure body mass, height, and resting blood pressure. Members of the research team will also help potential participants complete a Current Health Status Questionnaire, which will assess the potential participant's age, self-reported physical activity levels, and any medications or medical conditions that are relevant to the study.
Visit 1: Baseline Assessment: Participants will be asked to arrive after an overnight fast (i.e., no food or drink except for water for 8-12 hours). First, the investigators will perform a finger prick assessment to confirm eligibility and then evaluate body composition using dual-energy X-ray absorptiometry (DXA). Participants will be provided with a 3-day food diary and activity monitor at the conclusion of Visit 1, along with instructions on how to complete both.
Visit 2: Nutrition Intervention: After an overnight fast, participants will be asked to consume the high-fat test meal. The high-fat test meal will consist of bacon, eggs, cheese, tortilla, hashbrowns and mayonnaise (846 kcal, 58% fat, 29% carbohydrate, 13% protein). Members of the research team will prepare the meals in our metabolic kitchen. Before and after the meal is consumed, the researchers will take a series of blood samples and perform repeated resting VO2 measurements.
- Conditions
- Healthy Nutrition
- Being tested
- High-fat test meal
- Keywords
- glucose metabolism, lipid metabolism, substrate oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat test mealOther
Ingestion of a mixed macronutrient breakfast meal providing 846 kcal, of which 58% is fat, 29% is carbohydrate and 13% is protein.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: High-fat test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin
Peak postprandial concentration and/or area under the curve
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Peak postprandial concentration and/or area under the curve
Measured: 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)
Peak postprandial concentration and/or area under the curve
Measured: 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
Peak postprandial concentration and/or area under the curve
Measured: 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)
Average resting RER over a 10-minute sampling period
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start4 Oct 2022
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsten Bell
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor-investigator, Kirsten Bell, McMaster University
- Investigators
- Kirsten E Bell, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332301
- Sponsor's protocol ID
- 14714
- Acronym
- HFM
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with anyone outside of the research team.
Publications
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.
PubMed 31958145Bachmann 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.
PubMed 11679437Lundsgaard 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.
PubMed 33122393Chiu 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.
PubMed 31647036Ando 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.
PubMed 29924301Parry 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.
PubMed 31513265Whytock 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.
PubMed 32789769Alayón, 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).
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.
PubMed 28673468Obeid 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.
PubMed 30200465
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Sex Differences in the Acute Postprandial Metabolic Response to a High-fat Mixed Macronutrient Meal Challenge in Healthy Young Humans
- ClinicalTrials.gov ID
- NCT05332301
- Acronym / sponsor ID
- HFM / 14714
- Conditions
- Healthy Nutrition
- Keywords
- glucose metabolism, lipid metabolism, substrate oxidation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kirsten BellUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Long-term high-fat feeding is known to induce insulin resistance and impair whole-body glucose clearance in humans, yet knowledge of the glucose metabolic effects of high-fat feeding remains incomplete. Excess fat consumption leads to elevated circulating concentrations of non-esterified fatty acids (NEFAs), which (when taken up by muscle, an organ vital for glucose homeostasis) may interfere with insulin signaling and glucose disposal.
Despite the relatively rich body of research on high-fat feeding, the acute (i.e., 1-4 hours post-ingestion) effects of a high-fat meal on postprandial glucose metabolism are poorly characterized. Understanding the acute response to high-fat feeding is a key step towards uncovering the mechanisms that drive the development of dietary fat-induced insulin resistance. Limited work suggests that postprandial insulinemia may be elevated in response to a high-fat meal, and that this effect may be more pronounced in individuals with higher adiposity. Previous work has shown that ingestion of a mixed macronutrient meal high in saturated fat (~60% total fat, 32% saturated fat) stimulated significantly greater increases in circulating insulin concentrations in obese compared with lean middle-aged subjects. The effect of acute high-fat feeding on postprandial glycemia is less clear: studies have reported increased, decreased, or no change in glucose concentrations in response to a high-fat challenge. The quantity of fat administered may help explain these conflicting reports: studies have variously employed meals comprising 40%, 60% and up to 80% fat. These discrepancies in the literature may also be underpinned by the inclusion of males and females in the same study.
There is a paucity of data on the glucose metabolic response to high-fat feeding in human females. Although a handful of studies have included female subjects, this may have masked potentially divergent effects of high-fat feeding on glucose metabolism in males compared with females. Generally speaking, females have lower fasting plasma glucose concentrations (indicative of heightened hepatic insulin sensitivity) and are more adept at storing circulating NEFAs as subcutaneous adipose tissue (SAT). Although males have greater skeletal muscle mass (an important glucose reservoir) and lower whole-body adiposity than females, they preferentially accumulate adipose tissue in depots associated with metabolic dysfunction, such as the viscera and skeletal muscle [30]. Indeed, only one study to date has directly compared males and females to show that 7 days of suprarenergetic high-fat feeding (+50% kcal/d, 65% fat) stimulated an increase in trunk fat mass in males, with no discernable body composition changes in females. Given these sex-based differences in insulin sensitivity and adipose tissue storage, it is possible that females exhibit a distinct glucose metabolic response to high-fat feeding compared to males. However, this hypothesis has yet to be fully explored.
Therefore, in this study, the investigators will administer a single high-fat mixed macronutrient meal to a group of healthy young adults. Over the 4-hour postprandial period, they aim to compare the following in females versus males:
- Circulating features of glucose metabolism (primary objective)
- Circulating features of lipid metabolism (secondary objective)
- Energy expenditure and substrate oxidation via indirect calorimetry (tertiary objective)
The investigators hypothesize that, compared with males, females will demonstrate:
- Lower circulating concentrations of glucose, insulin, c-peptide and glucagon
- Lower circulating concentrations of triglycerides, total cholesterol, low-density lipoprotein cholesterol and NEFAs; and higher circulating concentrations of high-density lipoprotein cholesterol
- Greater energy expenditure and fat oxidation, and lower carbohydrate oxidation
This acute nutrition intervention study will involve a total of 3 visits to the laboratory (initial screening visit plus 2 study visits). After a screening visit to assess eligibility, young adults who have consented to participate will report to the laboratory after an overnight on 2 separate occasions: Baseline Assessment (Visit 1) and Nutrition Intervention (Visit 2).
Screening visit: Eligibility will be assessed during a screening session at the laboratory. The investigators will measure body mass, height, and resting blood pressure. Members of the research team will also help potential participants complete a Current Health Status Questionnaire, which will assess the potential participant's age, self-reported physical activity levels, and any medications or medical conditions that are relevant to the study.
Visit 1: Baseline Assessment: Participants will be asked to arrive after an overnight fast (i.e., no food or drink except for water for 8-12 hours). First, the investigators will perform a finger prick assessment to confirm eligibility and then evaluate body composition using dual-energy X-ray absorptiometry (DXA). Participants will be provided with a 3-day food diary and activity monitor at the conclusion of Visit 1, along with instructions on how to complete both.
Visit 2: Nutrition Intervention: After an overnight fast, participants will be asked to consume the high-fat test meal. The high-fat test meal will consist of bacon, eggs, cheese, tortilla, hashbrowns and mayonnaise (846 kcal, 58% fat, 29% carbohydrate, 13% protein). Members of the research team will prepare the meals in our metabolic kitchen. Before and after the meal is consumed, the researchers will take a series of blood samples and perform repeated resting VO2 measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-fat test meal | Experimental | Other: High-fat test mealAll 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Smoking
- Diabetes, cancer, or other metabolic disorders
- Cardiac or gastrointestinal problems
- Infectious disease
- Barium swallow or nuclear medicine scan in the previous 3 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat test mealIngestion of a mixed macronutrient breakfast meal providing 846 kcal, of which 58% is fat, 29% is carbohydrate and 13% is protein. | Other | High-fat test meal |
Primary outcome
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
Peak postprandial concentration and/or area under the curve
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
Peak postprandial concentration and/or area under the curve
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
Peak postprandial concentration and/or area under the curve
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
Peak postprandial concentration and/or area under the curve
4 secondary outcomes
Plasma triglycerides
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 cholesterols (total and HDL)
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 non-esterified fatty acids
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
Respiratory exchange ratio (RER)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 31958145Whytock 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.
- Background: PubMed 11679437Bachmann 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.
- Background: PubMed 33122393Lundsgaard 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.
- Background: PubMed 31647036Chiu 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.
- Background: PubMed 29924301Ando 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.
- Background: PubMed 31513265Parry 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.
- Background: PubMed 32789769Whytock 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.
- BackgroundAlayón, 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: PubMed 28673468Wang 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.
- Background: PubMed 30200465Obeid 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.
- Individual participant dataSharing planned: No. No IPD will be shared with anyone outside of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten E Bell, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat test meal in people with Healthy Nutrition, run by Kirsten Bell at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten E Bell, PhD (905-525-9140 ext. 24872, bellke3@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05332301, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.