Health TrialsbyHealthPanel

Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases

ConditionHealthy Adult Females
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorUniversity of Ottawa

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English or French speaking

Ability to provide informed consent

Disqualifiers

History or evidence of chronic disease

Current use of hypolipemic medication

Current use of hormonal contraceptives

Current use of antidepressants

Trial design

Design model

Crossover

Treatments tested in this trial

  • Early Follicular Phase

    Other intervention

    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.

  • Mid-Luteal Phase

    Other intervention

    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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Early Follicular PhaseExperimental treatment 1 intervention
Group B: Mid-Luteal PhaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in plasma total triglyceride concentrations

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).

Time frame
6 hours
2

Change from baseline in plasma buoyant triglyceride concentrations

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).

Time frame
6 hours
3

Change from baseline in plasma denser triglyceride concentrations

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).

Time frame
6 hours
4

Change from baseline in plasma non-esterified fatty acid concentrations

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).

Time frame
6 hours

Secondary outcomes

1

Baseline serum β-estradiol concentrations

Serum β-estradiol concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline)

Time frame
Baseline
2

Baseline serum progesterone concentrations

Serum progesterone concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline)

Time frame
Baseline
3

Fasting resting energy expenditure

Fasting resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline).

Time frame
Baseline
4

Change from baseline in respiratory exchange ratio

Respiratory exchange ratio will be measured via indirect calorimetry upon arrival at the laboratory (baseline), and hourly for 6 hours following meal consumption.

Time frame
6 hours

Other outcomes

Sponsors and contacts

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University of Ottawa

Lead sponsor

Natural Sciences and Engineering Research Council, Canada

Collaborator

Hopital Montfort

Collaborator

Institut du Savoir Montfort

Collaborator

Source ClinicalTrials.gov
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