Dose Response Relationship Between Fat Ingestion and Metabolism

NCT ID: NCT05906342

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-04-30

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.

Detailed Description

The long-term consumption of high-fat foods can lead to unhealthy changes in the functioning of the body, giving rise to metabolic diseases such as type 2 diabetes. Similarly, short-term high-fat diets have also been shown to disrupt how the body performs but there is a lack of information regarding how a single high-fat meal can disrupt metabolism. Comparing meals of different fat quantity, without changing the overall energy intake (calories), will help us understand the short-term effect of fat ingestion on the functioning of the body and whether increasing the amount of fat in a meal is related to the level of dysfunction in the body. Therefore, the investigators will provide participants with four meals of varying fat quantity and in the period following the meal, the investigators will take blood samples to determine any changes that occur in the body in response to different levels of fat.

Conditions

Glucose Tolerance Impaired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

20% fat meal

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

Group Type: EXPERIMENTAL

20% fat meal

Intervention Type: OTHER

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

40% fat meal

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

Group Type: EXPERIMENTAL

40% fat meal

Intervention Type: OTHER

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

60% fat meal

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

Group Type: EXPERIMENTAL

60% fat meal

Intervention Type: OTHER

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

80% fat meal

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

Group Type: EXPERIMENTAL

80% fat meal

Intervention Type: OTHER

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

Interventions

20% fat meal

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

Intervention Type: OTHER

40% fat meal

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

Intervention Type: OTHER

60% fat meal

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

Intervention Type: OTHER

80% fat meal

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

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
• Follow a strict vegan diet
• Pregnant or breastfeeding (females only)
• Diagnosis of polycystic ovary syndrome (females only)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Bell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

16153

Identifier Type: -

Identifier Source: org_study_id