RecruitingNot ApplicableNCT07620587

The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance


Sponsor

Wilfrid Laurier University

Enrollment

60 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to determine if estradiol and progesterone are involved in appetite regulation and energy balance. The study aims to complete a 13 day randomized controlled trial (RCT) where oral supplementation of estradiol only, progesterone only, a combination of each, or a placebo in young males will be provided. During the supplementation period, participants will complete two in-lab sessions where they will complete an acute bout of high-intensity interval training or a period of seated rest (completed on separate days by each participant) and have blood samples and perceptions of appetite measured taken over the course of the in-lab sessions. At the end of each session participants will consume an ad-libitum meal and participants will also track free-living energy intake and wear a thigh-worn accelerometer to measure energy expenditure for three days (day before, day of, and day after) each in-lab session.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 30 Years

Inclusion Criteria17

  • ages 18-30 years
  • deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
  • non-smoking
  • contraindications to exercise as indicated by the (CSEP-GAQ)
  • hypersensitivity or allergy to estradiol, progesterone, cellulose, or capsule components
  • having been diagnosed with any metabolic disease (ie. diabetes, metabolic syndrome) or current diagnosis of overweight/obesity (BMI > 30.0)
  • personal of family history of stroke or thrombotic (blood clot) disease, blood clot disorder, venous or arterial thromboembolic disease, or any possible blood clotting disease
  • currently taking anticoagulants, antidiabetic medications, cyclosporine, antihypertensives, and CYP3A4 inducers or inhibitors (e.g., rifampin, ketoconazole, St. John's Wort)
  • known liver dysfunction or liver disease
  • history of ophthalmic vascular disease
  • hormone-dependent malignancies or previous diagnosis of cancer
  • recent major surgery (within ~6 months)
  • prolonged use of a cast or presence of immobility deeming inability to exercise, diagnosis of inflammatory disorders (ie. rheumatoid arthritis, celiac disease, inflammatory bowel disease)
  • history of sensitivity to or extreme nausea/vomiting or any gastrointestinal disorder
  • diagnosis of mental health or mood disorder
  • presence of abnormal eating behaviours as assessed by the Food Cravings State Questionnaire and the Three Factor Eating Questionnaire
  • diagnosed or presence of porphyria or classical migraines

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Interventions

DRUGPlacebo Comparator

See description of intervention arm.

DRUGEstradiol Only

See description of intervention arm.

DRUGProgesterone Only

See description of intervention arm.

DRUGEstradiol and Progesterone Combination

See description of intervention arm.


Locations(1)

Energy Metabolism Research Laboratory

Waterloo, Ontario, Canada

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NCT07620587


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