Healthy Adult FemalesNCT07459465
Postprandial Triglyceride Concentrations Across Menstrual Cycle Phases
A study testing Early Follicular Phase and Mid-Luteal Phase in people with Healthy Adult Females, run by University of Ottawa at 1 site in Canada.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Females
- What is being tested?
- Early Follicular Phase and Mid-Luteal Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 26 Mar 2026to 9 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English or French speaking
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
Ottawa, Ontario, K1S 5S9
About this study
Official title: Effect of Menstrual Cycle Phases on Postprandial Triglyceride Concentrations in Healthy Premenopausal Females: A Crossover Study
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).
- Conditions
- Healthy Adult Females
- Being tested
- Early Follicular Phase, Mid-Luteal Phase
- Keywords
- Triglyceride, Postprandial Lipemia, High-Fat Meal, Menstrual Cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase | Experimental | Not described Receives: Other: Early Follicular Phase |
| Mid-Luteal Phase | Experimental | Not described Receives: Other: Mid-Luteal Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 hours
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).
Measured: 6 hours
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).
Measured: 6 hours
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).
Measured: 6 hours
Change from baseline in plasma insulin concentrations
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).
Measured: 6 hours
Change from baseline in plasma glucose concentrations
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).
Measured: 6 hours
Change from baseline in plasma β-hydroxybutyrate concentrations
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).
Measured: 6 hours
Secondary outcomes (11)
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)
Measured: Baseline
Baseline serum progesterone concentrations
Serum progesterone concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline)
Measured: Baseline
Fasting resting energy expenditure
Fasting resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline).
Measured: Baseline
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.
Measured: 6 hours
Change from baseline in desire to eat
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)).
Measured: 6 hours
Change from baseline in hunger
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))
Measured: 6 hours
Change from baseline in fullness
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)).
Measured: 6 hours
Change from baseline in prospective food consumption
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)).
Measured: 6 hours
Change from baseline in resting energy expenditure
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.
Measured: 6 hours
Change from baseline in carbohydrate oxidation rate
Carbohydrate oxidation rate will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and hourly for 6 hours following meal consumption.
Measured: 6 hours
Change from baseline in lipid oxidation rate
Carbohydrate oxidation rate will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and hourly for 6 hours following meal consumption.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start26 Mar 2026
- Primary completion9 Aug 2026
- Study completion9 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Hopital Montfort, Institut du Savoir Montfort
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459465
- Sponsor's protocol ID
- H-06-18-837-2026
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menstrual Cycle Phases on Postprandial Triglyceride Concentrations in Healthy Premenopausal Females: A Crossover Study
- ClinicalTrials.gov ID
- NCT07459465
- Acronym / sponsor ID
- H-06-18-837-2026
- Conditions
- Healthy Adult Females
- Keywords
- Triglyceride, Postprandial Lipemia, High-Fat Meal, Menstrual Cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Hopital Montfort, Institut du Savoir Montfort
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 9 Aug 2026 (actual)
- Study completion
- 9 Aug 2026 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Follicular Phase | Experimental | Other: Early Follicular Phase |
| Mid-Luteal Phase | Experimental | Other: Mid-Luteal Phase |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English or French speaking
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- History or evidence of chronic disease
- Current use of hypolipemic medication
- Current use of hormonal contraceptives
- Current use of antidepressants
- Current use of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Follicular PhaseIn 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 | Early Follicular Phase |
| Mid-Luteal PhaseIn 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. | Other | Mid-Luteal Phase |
Primary outcome
Change from baseline in plasma total triglyceride concentrations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Follicular Phase and Mid-Luteal Phase in people with Healthy Adult Females, run by University of Ottawa at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in plasma total triglyceride concentrations (time frame: 6 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.