Recruiting

Estradiol & Progesterone

Sponsor:

Wilfrid Laurier University

Code:

NCT07620587

Conditions

Energy Balance

Physiology - Regulation of Appetite and Food Intake

Eligibility Criteria

Sex: Male

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Placebo Comparator

Estradiol Only

Progesterone Only

Estradiol and Progesterone Combination

Study Details

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.

Conditions

Energy Balance

Physiology - Regulation of Appetite and Food Intake

Study ID

NCT07620587

Start date

Jun 1, 2026

Status verified date

May, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Comparator

Participants will be randomized and placed into one of four groups. The placebo group will receive 400 milligrams (mg) per day of glucose polymer for 13 days total. The supplementation will be consumed orally at the same time every day for 13 days total. Participants will not complete more than one arm of the study.

experimental: Estradiol Only

Participants will receive 1 mg per day for 2 days and 2 mg per day of estradiol for 11 days + 300 mg polycose. The supplementation will be consumed orally at the same time every day for 13 days total. Participants will not complete more than one arm of the study.

experimental: Progesterone Only

Participants will receive 100 mg per day of Prometrium (oral progesterone) for 13 days. The supplementation will be consumed orally at the same time every day for 13 days total. Participants will not complete more than one arm of the study.

experimental: Estradiol and Progesterone Combo

Participants will receive 1 mg per day for 2 days and 2 mg per day estradiolfor 11 days + 300 mg polycose as well as 100 mg per day of Prometrium (oral progesterone). The supplementation will be consumed orally at the same time every day for 13 days total. Participants will not complete more than one arm of the study.

Interventions

Placebo Comparator

See description of intervention arm.

Estradiol Only

See description of intervention arm.

Progesterone Only

See description of intervention arm.

Estradiol and Progesterone Combination

See description of intervention arm.

Primary outcome measure

  • Energy balance [ Time Frame: Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total). ]
  • Acylated Ghrelin [ Time Frame: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise. ]
  • Glucagon-like Peptide 1 (GLP-1) [ Time Frame: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise. ]
  • Cholecystokinin (CCK) [ Time Frame: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise. ]

Central Contacts and Locations

Central contacts

Jessica Tucker, MKin, PhD Candidate

519-884-1970tuck5010@mylaurier.ca

Locations

Energy Metabolism Research Laboratory

Recruiting

Waterloo, Ontario, Canada, N2L 3C5

Contacts

Jessica Tucker, MKin, PhD Candidate

519-884-1970tuck5010@mylaurier.ca

More Information

Sponsor

Wilfrid Laurier University

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • ovarian hormones
  • energy intake
  • appetite regulation
  • appetite-regulating hormones
  • energy balance
  • regulation of food intake

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wilfrid Laurier University on 2026-06-02.