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Recruiting NCT07459465

Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases

No phase Interventional Healthy Adult Females

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Follicular Phase, Mid-Luteal Phase.
Who it may be relevant to
Registry conditions: Healthy Adult Females. Basic parameters: 18 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Menstrual Cycle Phases on Postprandial Triglyceride Concentrations in Healthy Premenopausal Females: A Crossover Study

Overview

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

  • Other 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.
  • Other 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.

Primary outcome measures

  • Change from baseline in plasma total triglyceride concentrations [Time frame: 6 hours]
  • Change from baseline in plasma buoyant triglyceride concentrations [Time frame: 6 hours]
  • Change from baseline in plasma denser triglyceride concentrations [Time frame: 6 hours]
  • Change from baseline in plasma non-esterified fatty acid concentrations [Time frame: 6 hours]
  • Change from baseline in plasma insulin concentrations [Time frame: 6 hours]
  • Change from baseline in plasma glucose concentrations [Time frame: 6 hours]
  • Change from baseline in plasma β-hydroxybutyrate concentrations [Time frame: 6 hours]
Secondary outcome measures (11)
  • Baseline serum β-estradiol concentrations [Time frame: Baseline]
  • Baseline serum progesterone concentrations [Time frame: Baseline]
  • Fasting resting energy expenditure [Time frame: Baseline]
  • Change from baseline in respiratory exchange ratio [Time frame: 6 hours]
  • Change from baseline in desire to eat [Time frame: 6 hours]
  • Change from baseline in hunger [Time frame: 6 hours]
  • Change from baseline in fullness [Time frame: 6 hours]
  • Change from baseline in prospective food consumption [Time frame: 6 hours]
  • Change from baseline in resting energy expenditure [Time frame: 6 hours]
  • Change from baseline in carbohydrate oxidation rate [Time frame: 6 hours]
  • Change from baseline in lipid oxidation rate [Time frame: 6 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

Canada · 1 center
  • Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Scien — Ottawa

Identifiers

NCT: NCT07459465 · H-06-18-837-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗