- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07459465
Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases
Effect of Menstrual Cycle Phases on Postprandial Triglyceride Concentrations in Healthy Premenopausal Females: A Crossover Study
The goal of this clinical trial is to investigate the effect of menstrual cycle phases on postprandial triglyceride concentrations in healthy young female adults. The main question it aims to answer is: do postprandial triglyceride concentrations differ between the follicular and luteal phases of the menstrual cycle?
Participants will: visit the laboratory for a preliminary screening session to assess eligibility, and undergo two experimental sessions consisting of six hours of seated rest following the consumption of a high-fat meal (one session conducted in the early follicular phase, and one session conducted in the mid-luteal phase of the menstrual cycle).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pascal Imbeault, PhD
- Phone Number: 6135625800 ext 7290
- Email: imbeault@uottawa.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1S 5S9
- Recruiting
- Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
-
Contact:
- Pascal Imbeault
- Phone Number: 7290 16135625800
- Email: imbeault@uottawa.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- English or French speaking
- Ability to provide informed consent
Exclusion Criteria:
- History or evidence of chronic disease
- Current use of hypolipemic medication
- Current use of hormonal contraceptives
- Current use of antidepressants
- Current use of anticoagulants
- Ongoing smoking status
- Experiencing pregnancy, puerperium, or irregular menstrual cycles
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Early Follicular Phase
|
In the early follicular phase of the menstrual cycle, participants will undergo 6 hours of seated rest after the consumption of a high-fat meal representing 33% of estimated daily energy expenditure and consisting of 59% of calories from fat.
|
|
Experimental: Mid-Luteal Phase
|
In the mid-luteal phase of the menstrual cycle, participants will undergo 6 hours of seated rest after the consumption of a high-fat meal representing 33% of estimated daily energy expenditure and consisting of 59% of calories from fat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in plasma total triglyceride concentrations
Time Frame: 6 hours
|
Plasma total triglyceride concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma buoyant triglyceride concentrations
Time Frame: 6 hours
|
Plasma buoyant triglyceride concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma denser triglyceride concentrations
Time Frame: 6 hours
|
Plasma denser triglyceride concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma non-esterified fatty acid concentrations
Time Frame: 6 hours
|
Plasma non-esterified fatty acid concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma insulin concentrations
Time Frame: 6 hours
|
Plasma insulin concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma glucose concentrations
Time Frame: 6 hours
|
Plasma glucose concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 30, 60, 90,120, 180, 240, 300, and 360 minutes).
|
6 hours
|
|
Change from baseline in plasma β-hydroxybutyrate concentrations
Time Frame: 6 hours
|
Plasma β-hydroxybutyrate concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline serum β-estradiol concentrations
Time Frame: Baseline
|
Serum β-estradiol concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline)
|
Baseline
|
|
Baseline serum progesterone concentrations
Time Frame: Baseline
|
Serum progesterone concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline)
|
Baseline
|
|
Change from baseline in respiratory exchange ratio
Time Frame: 6 hours
|
Respiratory exchange ratio will be measured via indirect calorimetry upon arrival at the laboratory (baseline), and hourly for 6 hours following meal consumption.
|
6 hours
|
|
Change from baseline in desire to eat
Time Frame: 6 hours
|
Scores of subjective desire to eat, measured using visual analog scales.
Measurements are performed upon arrival at the laboratory (baseline) and hourly during the 6-hour exposure.
Scores will be measured using semantic differential scales in the form of 100-mm visual analog scales.
For desire to eat, the question will be asked as follows: "How strong is your desire to eat?" (very weak (0 mm) - very strong (100 mm)).
|
6 hours
|
|
Change from baseline in hunger
Time Frame: 6 hours
|
Scores of subjective hunger, measured using visual analog scales.
Measurements are performed upon arrival at the laboratory (baseline) and hourly during the 6-hour exposure.
Scores will be measured using semantic differential scales in the form of 100-mm visual analog scales.
For hunger, the question will be asked as follows: "How hungry do you feel?" (not hungry at all (0 mm) - as hungry as I have ever felt (100 mm))
|
6 hours
|
|
Change from baseline in fullness
Time Frame: 6 hours
|
Scores of subjective fullness, measured using visual analog scales.
Measurements are performed upon arrival at the laboratory (baseline) and hourly during the 6-hour exposure.
Scores will be measured using semantic differential scales in the form of 100-mm visual analog scales.
For fullness, the question will be asked as follows: How full do you feel?" (not full at all (0 mm) - very full (100 mm)).
|
6 hours
|
|
Change from baseline in prospective food consumption
Time Frame: 6 hours
|
Scores of subjective prospective food consumption, measured using visual analog scales.
Measurements are performed upon arrival at the laboratory (baseline) and hourly during the 6-hour exposure.
Scores will be measured using semantic differential scales in the form of 100-mm visual analog scales.
For prospective food consumption, the question will be asked as follows: "How much food do you think you could eat?" (nothing at all (0 mm) - a large amount (100 mm)).
|
6 hours
|
|
Fasting resting energy expenditure
Time Frame: Baseline
|
Fasting resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline).
|
Baseline
|
|
Change from baseline in resting energy expenditure
Time Frame: 6 hours
|
Resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and hourly for 6 hours following meal consumption.
The thermic effect of food is defined as the increase in resting energy expenditure above the fasting baseline value.
|
6 hours
|
|
Change from baseline in carbohydrate oxidation rate
Time Frame: 6 hours
|
Carbohydrate oxidation rate will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and hourly for 6 hours following meal consumption.
|
6 hours
|
|
Change from baseline in lipid oxidation rate
Time Frame: 6 hours
|
Carbohydrate oxidation rate will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and hourly for 6 hours following meal consumption.
|
6 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-06-18-837-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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