Dose Response Relationship Between Fat Ingestion and Metabolism

Glucose Tolerance Impaired Clinical Trial

— AFDR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906342
• Other study ID #: 16153
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: April 2024

Study information

• Verified date: June 2023
• Source: McMaster University
• Contact: Kirsten E Bell, Ph.D.
• Phone: 905 525 9140
• Email: bellke3[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• Glucose Tolerance Impaired

Intervention

Other:
• 20% fat meal
Provided to participants once throughout duration of study, contains 20% fat
• 40% fat meal
Provided to participants once throughout duration of study, contains 40% fat
• 60% fat meal
Provided to participants once throughout duration of study, contains 60% fat
• 80% fat meal
Provided to participants once throughout duration of study, contains 80% fat

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hunger hormones	Postprandial concentration of ghrelin (pmol/L)	During the 4-hour postprandial period
Other	Hunger hormones	Postprandial concentration of leptin (pmol/L)	During the 4-hour postprandial period
Other	Hunger hormones	Postprandial concentration of adiponectin (pmol/L)	During the 4-hour postprandial period
Primary	Glucose tolerance	A 2-hour intravenous glucose tolerance test will be performed 4-hours after meal consumption	Two hours (taking place following the 4-hour postprandial period)
Secondary	Glucose and lipid metabolites	Postprandial availability of glucose (mM)	During the 4-hour postprandial period
Secondary	Glucose and lipid metabolites	Postprandial availability of insulin (µIU/mL)	During the 4-hour postprandial period
Secondary	Glucose and lipid metabolites	Postprandial availability of total cholesterol (mmol/L)	During the 4-hour postprandial period
Secondary	Glucose and lipid metabolites	Postprandial availability of low-density lipoprotein (mmol/L)	During the 4-hour postprandial period
Secondary	Glucose and lipid metabolites	Postprandial availability of high-density lipoprotein (mmol/L)	During the 4-hour postprandial period
Secondary	Glucose and lipid metabolites	Postprandial availability of non-esterified fatty acids (mmol/L)	During the 4-hour postprandial period