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

NCT07620587 | Recruiting

• 1 other identifier: EMRL-25-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Energy balance

  Energy balance will be calculated as the difference between energy intake and energy expenditure (see below for description of energy intake and energy expenditure).

  Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).

• Acylated Ghrelin

  Appetite-stimulating hormone acylated ghrelin to be measured via commercially available ELISA kits (pg/mL).

  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)

  Appetite-inhibiting hormone GLP-1 to be measured via commercially available ELISA kits (pmol/L).

  To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.

• Cholecystokinin (CCK)

  Appetite-inhibiting hormone CCK to be measured via commercially available ELISA kits (pg/ml).

  To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.

Secondary Outcomes (29)

• Appetite perceptions

  Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.

• Food Preferences

  Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.

• Ad libitum meal energy intake

  At the end of each in-lab session (exercise and seated rest; 2 meals total).

• Free-living energy intake

  Day before, day of, and day after each in-lab session (6 days total).

• Energy expenditure

  Day before, day of, and day after each in-lab session (6 days total).

Study Arms (4)

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.

Drug: Placebo Comparator

Estradiol Only

EXPERIMENTAL

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.

Drug: Estradiol Only

Progesterone Only

EXPERIMENTAL

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.

Drug: Progesterone Only

Estradiol and Progesterone Combo

EXPERIMENTAL

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.

Drug: Estradiol and Progesterone Combination

Interventions

Placebo Comparator DRUG

See description of intervention arm.

Placebo Comparator

Estradiol Only DRUG

See description of intervention arm.

Estradiol Only

Progesterone Only DRUG

See description of intervention arm.

Progesterone Only

Estradiol and Progesterone Combination DRUG

See description of intervention arm.

Estradiol and Progesterone Combo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-30 years
• deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
• non-smoking

You may not qualify if:

• 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

Sponsors & Collaborators

• Wilfrid Laurier University: lead

Study Sites (1)

Energy Metabolism Research Laboratory

Waterloo, Ontario, N2L 3C5, Canada

RECRUITING

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Tom J Hazell, PhD

  Wilfrid Laurier University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Tucker, MKin, PhD Candidate

CONTACT

519-884-1970; tuck5010@mylaurier.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be a double-blind, non-crossover study comprising four arms. The allocation of treatment will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into one of four groups where they will receive one of four possible treatments.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CA (1)