NCT07459465

Brief 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? 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 19, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 3, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

TriglyceridePostprandial LipemiaHigh-Fat MealMenstrual Cycle

Outcome Measures

Primary Outcomes (7)

  • 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).

    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).

    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).

    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).

    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).

    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).

    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).

    6 hours

Secondary Outcomes (11)

  • Baseline serum β-estradiol concentrations

    Baseline

  • Baseline serum progesterone concentrations

    Baseline

  • Fasting resting energy expenditure

    Baseline

  • Change from baseline in respiratory exchange ratio

    6 hours

  • Change from baseline in desire to eat

    6 hours

  • +6 more secondary outcomes

Study Arms (2)

Early Follicular Phase

EXPERIMENTAL
Other: Early Follicular Phase

Mid-Luteal Phase

EXPERIMENTAL
Other: Mid-Luteal Phase

Interventions

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.

Early Follicular 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.

Mid-Luteal Phase

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English or French speaking
  • Ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ottawa, Ontario, K1S 5S9, Canada

RECRUITING

Central Study Contacts

Pascal Imbeault, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 19, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations