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View on ClinicalTrials.gov

Comparing Early Follicular Phase with Mid-Luteal Phase for healthy adult females

Official title: Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases

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

Condition: Healthy Adult FemalesSponsor: University of OttawaTarget enrollment: 12
  • 2 groups
  • One site, in Ottawa
  • Recruiting
Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, Ontario

Interventions

  • Other intervention

    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 intervention

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa

    Ottawa, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for9 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +English or French speaking
  • +Ability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →

Exclusion

  • History or evidence of chronic disease
  • Current use of hypolipemic medication
  • Current use of antidepressants
  • Current use of anticoagulants
  • Current use of hormonal contraceptives
  • Experiencing pregnancy, puerperium, or irregular menstrual cycles
  • Ongoing smoking status
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is investigating how something functions in the body, rather than testing a treatment directly.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Early Follicular Phase.

Registry label: A: Early Follicular Phase

Group B receives Mid-Luteal Phase.

Registry label: B: Mid-Luteal Phase

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 30 years.

The study lists female participants only.

The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 12 people.

The study is currently expected to finish around August 2026.

The main measurement is taken over: 6 hours.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → in plasma total triglyceride concentrations — measured over 6 hours.

Change from baseline in plasma buoyant triglyceride concentrations — measured over 6 hours.

Change from baseline in plasma denser triglyceride concentrations — measured over 6 hours.

Change from baseline in plasma non-esterified fatty acid concentrations — measured over 6 hours.

The study lists 3 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07459465 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Early Follicular PhaseOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Mid-Luteal PhaseOther

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.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 30 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 30 years.

It lists female participants only.

It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: 6 hours.

The study as a whole is currently expected to finish around 2026-08-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 12 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Ottawa, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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).

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.