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Menstrual Cycle Phases for Triglyceride Levels

PI
Overseen ByPascal Imbeault, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different phases of the menstrual cycle affect triglyceride levels (a type of fat in the blood) after consuming a high-fat meal. It focuses on the early follicular phase and the mid-luteal phase to determine any differences. Participants will attend two lab sessions, each involving a meal followed by rest. The trial seeks healthy young women who do not smoke, use certain medications, and have regular menstrual cycles.

As an unphased study, this research allows participants to contribute to a better understanding of how menstrual cycles impact health.

Will I have to stop taking my current medications?

If you are currently using hypolipemic medication, hormonal contraceptives, antidepressants, or anticoagulants, you cannot participate in this trial.

What prior data suggests that this protocol is safe?

Previous studies have examined how different stages of the menstrual cycle affect blood fat levels, including triglycerides. These studies suggest that triglyceride levels are usually higher during the early part of the cycle compared to the middle. However, these differences were not always significant enough to impact health.

Regarding safety, this trial does not test a new drug or treatment. It simply observes natural changes in the body during different menstrual cycle stages. No reports of serious side effects have emerged from this type of study, so it is generally considered safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different phases of the menstrual cycle, specifically the Early Follicular and Mid-Luteal phases, might impact triglyceride levels. Unlike traditional methods that treat high triglycerides with medications like statins or fibrates, this approach examines natural hormonal fluctuations as a potential influencer. By understanding these hormonal effects, the trial could open new pathways for managing triglyceride levels without relying solely on medication. This innovative angle might lead to personalized and potentially less invasive strategies for managing triglyceride levels in the future.

What evidence suggests that this trial's treatments could be effective for triglyceride levels?

This trial will compare triglyceride levels during different phases of the menstrual cycle. Researchers will study participants during the Early Follicular Phase and the Mid-Luteal Phase. Research has shown that triglyceride levels, a type of fat, are usually higher at the start of the cycle (early follicular phase) than later on (mid-luteal phase). One study found that triglyceride levels can drop by up to 30% during the luteal phase. Another study observed that the ratio of triglycerides to "good" cholesterol (HDL) also decreases during this phase. This suggests that the menstrual cycle can influence how the body processes fats after eating.12367

Are You a Good Fit for This Trial?

This trial is for healthy adult women who speak English or French and can give informed consent. Participants should not have any health conditions that would prevent them from safely taking part.

Inclusion Criteria

I can speak English or French.
I am able to understand and agree to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session
1 visit (in-person)

Early Follicular Phase

Participants undergo a 6-hour experimental session following the consumption of a high-fat meal during the early follicular phase of the menstrual cycle

6 hours
1 visit (in-person)

Mid-Luteal Phase

Participants undergo a 6-hour experimental session following the consumption of a high-fat meal during the mid-luteal phase of the menstrual cycle

6 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental sessions

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Early Follicular Phase
  • Mid-Luteal Phase

Trial Overview

The study compares how the body processes fats after eating a high-fat meal during two different phases of the menstrual cycle: early follicular and mid-luteal. Each participant completes both sessions in a controlled lab setting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Mid-Luteal PhaseExperimental Treatment1 Intervention
Group II: Early Follicular PhaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Ottawa

Lead Sponsor

Trials
231
Recruited
267,000+

Natural Sciences and Engineering Research Council, Canada

Collaborator

Trials
63
Recruited
3,000+

Hopital Montfort

Collaborator

Trials
15
Recruited
5,000+

Institut du Savoir Montfort

Collaborator

Trials
2
Recruited
210+

Institut du Savoir Montfort

Collaborator

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/3597711/

Effect of menstrual cycle phase on plasma lipids - PubMed - NIH

These data indicate that menstrual cycle phase can have a significant effect on plasma triglyceride levels, but not on plasma cholesterol or lipoprotein ...

Variations in lipid levels according to menstrual cycle phase

The evidence suggests that total cholesterol and LDL-C tend to be highest during the follicular phase and to decline during the luteal phase, with HDL C ...

Lipid metabolism in women: A review

During adulthood, premenopausal women have a more favorable lipid profile with higher HDL cholesterol and lower LDL cholesterol levels compared to men [17,18].

Association between menstrual cycle phase and metabolites ...

Total, LDL and total to HDL cholesterol were highest in the early follicular phase and declined during the luteal phase, whereas HDL cholesterol ...

Menstrual Cycle Phases for Triglyceride Levels

The goal of this clinical trial is to investigate the effect of menstrual cycle phases on postprandial triglyceride concentrations in healthy young female ...

Can triglyceride levels be elevated during menstruation?

A 2017 study found lower triglyceride levels in the luteal phase compared to the follicular phase, though the difference was not statistically ...

The surprising influence of female hormones on lab results

Research shows that concentrations of various hormones fluctuating throughout the menstrual cycle may have significant effects on levels of biomarkers.