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OpenTrials
Completed

NCT Number: NCT05906342

Dose Response Relationship Between Fat Ingestion and Metabolism

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University, Ivor Wynne Centre

Hamilton, Ontario, L8S 3X3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

20% fat meal

Other

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

40% fat meal

Other

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

60% fat meal

Other

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

80% fat meal

Other

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

Primary outcomes

  1. Glucose tolerance

    Time frame: Two hours (taking place following the 4-hour postprandial period)

    A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption

Secondary outcomes

  1. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of glucose (mM)

  2. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of insulin (µIU/mL)

  3. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of total cholesterol (mmol/L)

  4. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of low-density lipoprotein (mmol/L)

  5. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of high-density lipoprotein (mmol/L)

  6. Glucose and lipid metabolites

    Time frame: During the 4-hour postprandial period

    Postprandial availability of non-esterified fatty acids (mmol/L)

Other outcomes

  1. Hunger hormones

    Time frame: During the 4-hour postprandial period

    Postprandial concentration of ghrelin (pmol/L)

  2. Hunger hormones

    Time frame: During the 4-hour postprandial period

    Postprandial concentration of leptin (pmol/L)

  3. Hunger hormones

    Time frame: During the 4-hour postprandial period

    Postprandial concentration of adiponectin (pmol/L)

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Investigating the Effect of Acute Fat Ingestion on Glucose Metabolism in Young Healthy Adults: a Dose Response Study

Acronym: AFDR

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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