Healthy Adult Females
Conditions
Keywords
Triglyceride, Postprandial Lipemia, High-Fat Meal, Menstrual Cycle
Brief summary
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).
Interventions
OTHEREarly 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.
OTHERMid-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.
Sponsors
University of Ottawa
Natural Sciences and Engineering Research Council, Canada
Hopital Montfort
Institut du Savoir Montfort
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in plasma total triglyceride concentrations | 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). |
| Change from baseline in plasma buoyant triglyceride concentrations | 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). |
| Change from baseline in plasma denser triglyceride concentrations | 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). |
| Change from baseline in plasma non-esterified fatty acid concentrations | 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). |
| Change from baseline in plasma insulin concentrations | 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). |
| Change from baseline in plasma glucose concentrations | 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). |
| Change from baseline in plasma β-hydroxybutyrate concentrations | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline serum β-estradiol concentrations | Baseline | Serum β-estradiol concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) |
| Baseline serum progesterone concentrations | Baseline | Serum progesterone concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) |
| Fasting resting energy expenditure | Baseline | Fasting resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline). |
| Change from baseline in respiratory exchange ratio | 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. |
| Change from baseline in desire to eat | 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)). |
| Change from baseline in hunger | 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)) |
| Change from baseline in fullness | 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)). |
| Change from baseline in prospective food consumption | 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)). |
| Change from baseline in resting energy expenditure | 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. |
| Change from baseline in carbohydrate oxidation rate | 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. |
| Change from baseline in lipid oxidation rate | 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. |
Countries
Canada
Outcome results
None listed