NCT07620587 The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance
| NCT ID | NCT07620587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wilfrid Laurier University |
| Condition | Energy Balance |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-06-01 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * ages 18-30 years * deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ) * non-smoking Exclusion Criteria: * failure to meet inclusion criteria * 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
Contact & Investigator
Tom J Hazell, PhD
PRINCIPAL INVESTIGATOR
Wilfrid Laurier University
Frequently Asked Questions
Who can join the NCT07620587 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 30 Years, studying Energy Balance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07620587 currently recruiting?
Yes, NCT07620587 is actively recruiting participants. Contact the research team at tuck5010@mylaurier.ca for enrollment information.
Where is the NCT07620587 trial being conducted?
This trial is being conducted at Waterloo, Canada.
Who is sponsoring the NCT07620587 clinical trial?
NCT07620587 is sponsored by Wilfrid Laurier University. The principal investigator is Tom J Hazell, PhD at Wilfrid Laurier University. The trial plans to enroll 60 participants.