High-fat Meal for Metabolism Study

(HFM Trial)

Overseen By Kirsten E Bell, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kirsten Bell

Disqualifiers: Smoking, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores why women might be less likely than men to develop insulin resistance after consuming high-fat meals. Participants will eat a high-fat test meal, similar to a fast-food breakfast, while researchers track how their bodies process it by monitoring blood sugar and energy use. The trial is open to healthy young adults who have maintained a stable weight and do not smoke or have metabolic disorders. By comparing men and women, the study aims to uncover metabolic differences that could enhance understanding of diabetes risks. As an unphased study, this research offers participants the chance to contribute to groundbreaking insights into gender differences in metabolism.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this high-fat test meal is safe for participants?

Research has shown that high-fat meals are generally safe for healthy individuals, though they can affect how the body processes certain substances. For instance, one study found that a high-fat meal could alter the absorption of some medications. This indicates that while the meal itself isn't harmful, it can influence bodily functions afterward.

Another study found that meals with varying fat levels primarily affect metabolism, which is how the body uses nutrients. This suggests that the body might process nutrients differently after eating, but it doesn't typically cause immediate health issues.

Overall, while high-fat meals can change how the body handles food and medications, healthy adults generally tolerate them well. These effects are short-term, and a single high-fat meal is usually not a concern for healthy individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore how a high-fat meal, similar to a fast-food breakfast, affects metabolism. Unlike traditional studies that might focus on medications or supplements, this approach uses a real-world dietary scenario to investigate metabolic responses. This could provide insights into how certain meal compositions impact energy use and fat processing in the body, potentially influencing dietary recommendations and understanding of metabolic health.

What evidence suggests that this high-fat test meal is effective for studying metabolism differences between men and women?

Research has shown that men and women might process high-fat meals differently. In this trial, participants will consume a high-fat test meal to study its effects on metabolism. One study found that eating a high-fat breakfast daily for four weeks helped the body burn more fat throughout the day. Another study discovered that meal fat content can alter young adults' bodily functions in the short term. These findings suggest that the body's reaction to high-fat meals can depend on factors like gender and meal composition. Understanding these differences might explain why women generally have better protection against insulin resistance, a condition linked to type 2 diabetes, compared to men. ^{2 6 7 8 9}

Who Is on the Research Team?

Kirsten E Bell, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for healthy young adults aged 18-35 with normal blood glucose and blood pressure, not using hormone-altering contraceptives, weight stable, BMI of 18.5-30, and exercising moderately. Smokers or those with heart issues, infectious diseases, pregnancy, certain syndromes/diets or unvaccinated against COVID19 can't join.

Inclusion Criteria

Fasting blood glucose <6.0 mM

BMI between 18.5 and 30.0 kg/m2

Weight stable for the past 6 months (± 2kg)

Exclusion Criteria

Pregnant or breastfeeding

Follow a vegan or vegetarian diet

Smoking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Baseline Assessment

Participants undergo a baseline assessment including body composition evaluation and receive a 3-day food diary and activity monitor

1 visit

1 visit (in-person)

Nutrition Intervention

Participants consume a high-fat test meal and undergo blood sampling and VO2 measurements

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-fat test meal

Trial Overview The study tests how men and women metabolize a high-fat meal differently by giving participants a 'fast-food' style breakfast and then measuring their blood glucose, insulin levels and energy burn over several hours to see the immediate metabolic effects.

How Is the Trial Designed?

Group I: High-fat test meal Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Kirsten Bell

Lead Sponsor

Trials

1

Recruited

20+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6251665/

A High-Fat Compared with a High-Carbohydrate Breakfast ... The present study shows that a high-fat breakfast consumed over 4 wk increases 24-h fat oxidation. Under acute settings (1-d fat challenge), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05906342

NCT05906342 | Dose Response Relationship Between Fat ... This study compares metabolism in young adults after meals with 20%, 40%, 60%, or 80% fat, to understand the short-term effect of fat ingestion.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6521626/

High-Fat Breakfast Meal Replacement in Overweight and ... The purpose of this paper was to determine the effect of replacing breakfast with a high-fat drink on fat mass (FM), lean mass (LM), percent body fat (%BF), ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322007487

The Effects of Breakfast Consumption and Composition on ... Findings from epidemiologic studies indicate that there are associations between breakfast consumption and a lower risk of type 2 diabetes mellitus (T2DM) ...

5. docs.lib.purdue.edu docs.lib.purdue.edu/cgi/viewcontent.cgi?article=2971&context=open_access_dissertations

The Effects of Dietary Protein at Breakfast and Across the Day ... The search terms included breakfast, breakfast skipping, and morning meal along with the following outcomes: appetite, hunger, satiety, fullness, ghrelin, GLP-1 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3247120/

The Effect of a High-Fat Breakfast on the Pharmacokinetics of ... The objective of this study was to assess the effect of a high-fat meal on the pharmacokinetics of moxidectin. Healthy male subjects were randomized to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1140540/

Effects of a High-Fat Meal on the Relative Oral ... The present data demonstrate that, relative to the fasting state, the oral bioavailability of PQ is approximately doubled by a high-fat meal.

8. fda.gov fda.gov/media/121313/download

Assessing the Effects of Food on Drugs in INDs and NDAs This FDA guidance covers assessing food effects on drugs in INDs/NDAs, including recommendations for FE studies, pilot/definitive studies, meal types, and ...

9. mdpi.com mdpi.com/2072-6643/14/14/2876

High-Fat or High-Carbohydrate Meal—Does It Affect the ... It was observed that following a high-fat or high-carbohydrate meal, men with excessive body weight metabolized the main nutrients differently than men with ...