Energy BalanceE2 & P4 in EBNCT07620587
The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance
A study testing Estradiol Only, Progesterone Only and Estradiol and Progesterone Combination in people with Energy Balance and Physiology - Regulation of Appetite and Food Intake, run by Wilfrid Laurier University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Energy Balance, Physiology - Regulation of Appetite and Food Intake
- What is being tested?
- Estradiol Only, Progesterone Only and Estradiol and Progesterone Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-30 years
- deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
- non-smoking
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Energy Metabolism Research Laboratory
Waterloo, Ontario, N2L 3C5
Jessica Tucker, MKin, PhD Candidate, 519-884-1970 ext. 4919, tuck5010@mylaurier.ca
About this study
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.
Read the detailed description
The purpose of this study is to further elucidate the individual and combined effects of estradiol and progesterone on appetite-regulating hormones, perceptions of appetite, energy intake, and energy expenditure over a 13 day supplementation period using a randomized controlled trial (RCT) model in males who will be supplemented with each hormone. Sixty healthy, recreationally active male participants will be randomized into one of four possible groups: placebo (PLA; 400 milligrams (mg) per day glucose polymer), estradiol only (E; 1 mg per day for 2 days \& 2 mg per day of estradiol for 11 days + 300 mg Polycose), progesterone only (P; Prometrium, 100 mg per day), or combined estradiol and progesterone (E+P; 1 mg per day for 2 days \& 2 mg per day of estradiol for 11 days + 300 mg Polycose for estradiol and 100 mg per day of Prometrium) for a total of ~15 per group. Participants will be provided enough daily dose of each treatment dependent on randomization for a total of 13 days and will be instructed to take each supplement orally at the same time each day for the entirety of the intervention. Participants will report to the lab on the 7th day, where they will be fed a standardized meal and then complete either an acute bout of high-intensity interval training (HIIT; 1 minute on, 1 minute off at 90% HRmax) or a period of seated rest (CTRL). Participants will return on day 12 to complete either the HIIT or CTRL session in an identical manner (whichever was not completed on day 7). Blood samples to measure appetite-regulating hormones and perceptions of appetite will be completed pre-exercise, 0-, 30-, 60-, and 120-minutes post-HIIT and CTRL. While participants are receiving the 13 day treatment, free-living energy intake will be assessed for a 3 day period (day before, day of and day after both in lab visits (HIIT/CTRL; days 6-8 and days 11-13) using the Keenoa® mobile application, and energy expenditure will be measured via thigh-worn accelerometers for the same 3 day periods. An ad libitum meal will also be provided following the HIIT and CTRL sessions.
We anticipate publishing this RCT in two separate manuscripts. Manuscript #1 will focus on the potential effects on the appetite-regulating hormones (acylated ghrelin, GLP-1, CCK) and perceptions of appetite. Manuscript #2 will focus on potential effects on energy balance from the measures of energy intake (including free-living and ad-libitum meal intake) and energy expenditure.
- Being tested
- Placebo Comparator, Estradiol Only, Progesterone Only, Estradiol and Progesterone Combination
- Keywords
- ovarian hormones, energy intake, appetite regulation, appetite-regulating hormones, energy balance, regulation of food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorDrug
See description of intervention arm.
Estradiol OnlyDrug
See description of intervention arm.
Progesterone OnlyDrug
See description of intervention arm.
Estradiol and Progesterone CombinationDrug
See description of intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Estradiol and Progesterone Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Subjective appetite perceptions will be assessed using visual analogue scales (VAS) validated for four perceptions: hunger (i.e., "How hungry do you feel?"), satisfaction (i.e., "How satisfied do you feel?"), fullness (i.e., "How full do you feel?"), and prospective food consumption (i.e., "How much do you think you can eat?").
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Food Preferences
For food preferences, a state food preference questionnaire is a survey or questionnaire used to gather information about individuals' food preferences, and dietary habits.
Measured: 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
A post in-lab session meal will be provided to all participants to determine their ad libitum energy intake for this meal by measuring the food provided before the meal as well as the amount of food not consumed using an analog scale .
Measured: At the end of each in-lab session (exercise and seated rest; 2 meals total).
Free-living energy intake
Participants will complete a 3 day food record around each in lab session using a mobile application (Keenoa®) monitored by a registered dietician.
Measured: Day before, day of, and day after each in-lab session (6 days total).
Energy expenditure
Energy expenditure will be measured for the same 3 days of the food records around both in-lab sessions measured using a thigh-worn accelerometer.
Measured: Day before, day of, and day after each in-lab session (6 days total).
Estradiol
Sex hormone estradiol measured via radioimmunoassay (pg/mL).
Measured: Pre-exercise only.
Progesterone
Sex hormone progesterone measured via radioimmunoassay (ng/mL).
Measured: Pre-exercise only.
Testosterone
Sex hormone testosterone measured via radioimmunoassay.
Measured: Pre-exercise only.
Blood glucose
Will be measured using biochemical assays prior to and following treatment.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Insulin
Will be measured using biochemical assays prior to and following treatment.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
C-Peptide
Will be measured using biochemical assays prior to and following treatment.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Peripheral Blood Mononuclear Cells
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Inflammatory Cytokines
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Brain-derived Neurotrophic Factor (BDNF)
Measured in blood samples via ELISA kits.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Cathepsin B
Measured in blood samples via ELISA kits.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Irisin
Measured in blood samples via ELISA kits.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Klotho
Measured in blood samples via ELISA kits.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Adrenocorticotropic Hormone
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Dickkopf-1 (DKK-1)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Fibroblast Growth Factor 23 (FGF-23)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin 1B (IL-1B)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin-6 (IL-6)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Tumor Necrosis Factor (TNF)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteocalcin
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteopontin
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteoprotegerin (OPG)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Parathyroid Hormone (PTH)
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Sclerostin
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Leptin
Measured in blood samples via immunoassays.
Measured: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into one of four groups where they will receive one of four possible treatments.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Hazell, Wilfrid Laurier University
- Investigators
- Tom J Hazell, PhD, Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620587
- Sponsor's protocol ID
- EMRL-25-01
- Acronym
- E2 & P4 in EB
- Status last verified
- May 2026
- First submitted
- 28 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data from this research study will be available to researchers upon review and approval of reasonable requests starting six months after manuscript publication. Proposals should be sent to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance
- ClinicalTrials.gov ID
- NCT07620587
- Acronym / sponsor ID
- E2 & P4 in EB / EMRL-25-01
- Keywords
- ovarian hormones, energy intake, appetite regulation, appetite-regulating hormones, energy balance, regulation of food intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to further elucidate the individual and combined effects of estradiol and progesterone on appetite-regulating hormones, perceptions of appetite, energy intake, and energy expenditure over a 13 day supplementation period using a randomized controlled trial (RCT) model in males who will be supplemented with each hormone. Sixty healthy, recreationally active male participants will be randomized into one of four possible groups: placebo (PLA; 400 milligrams (mg) per day glucose polymer), estradiol only (E; 1 mg per day for 2 days \& 2 mg per day of estradiol for 11 days + 300 mg Polycose), progesterone only (P; Prometrium, 100 mg per day), or combined estradiol and progesterone (E+P; 1 mg per day for 2 days \& 2 mg per day of estradiol for 11 days + 300 mg Polycose for estradiol and 100 mg per day of Prometrium) for a total of ~15 per group. Participants will be provided enough daily dose of each treatment dependent on randomization for a total of 13 days and will be instructed to take each supplement orally at the same time each day for the entirety of the intervention. Participants will report to the lab on the 7th day, where they will be fed a standardized meal and then complete either an acute bout of high-intensity interval training (HIIT; 1 minute on, 1 minute off at 90% HRmax) or a period of seated rest (CTRL). Participants will return on day 12 to complete either the HIIT or CTRL session in an identical manner (whichever was not completed on day 7). Blood samples to measure appetite-regulating hormones and perceptions of appetite will be completed pre-exercise, 0-, 30-, 60-, and 120-minutes post-HIIT and CTRL. While participants are receiving the 13 day treatment, free-living energy intake will be assessed for a 3 day period (day before, day of and day after both in lab visits (HIIT/CTRL; days 6-8 and days 11-13) using the Keenoa® mobile application, and energy expenditure will be measured via thigh-worn accelerometers for the same 3 day periods. An ad libitum meal will also be provided following the HIIT and CTRL sessions.
We anticipate publishing this RCT in two separate manuscripts. Manuscript #1 will focus on the potential effects on the appetite-regulating hormones (acylated ghrelin, GLP-1, CCK) and perceptions of appetite. Manuscript #2 will focus on potential effects on energy balance from the measures of energy intake (including free-living and ad-libitum meal intake) and energy expenditure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized into one of four groups where they will receive one of four possible treatments.
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorParticipants 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. |
| Estradiol Only | Experimental | Drug: Estradiol OnlyParticipants 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. |
| Progesterone Only | Experimental | Drug: Progesterone OnlyParticipants 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. |
| Estradiol and Progesterone Combo | Experimental | Drug: Estradiol and Progesterone CombinationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 18-30 years
- deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
- non-smoking
Key exclusion criteria (15 listed)
- failure to meet inclusion criteria
- contraindications to exercise as indicated by the (CSEP-GAQ)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo ComparatorSee description of intervention arm. | Drug | Placebo Comparator |
| Estradiol OnlySee description of intervention arm. | Drug | Estradiol Only |
| Progesterone OnlySee description of intervention arm. | Drug | Progesterone Only |
| Estradiol and Progesterone CombinationSee description of intervention arm. | Drug | Estradiol and Progesterone Combo |
Primary outcome
Energy balance
Time frame: Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).
Energy balance will be calculated as the difference between energy intake and energy expenditure (see below for description of energy intake and energy expenditure).
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.
Appetite-stimulating hormone acylated ghrelin to be measured via commercially available ELISA kits (pg/mL).
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.
Appetite-inhibiting hormone GLP-1 to be measured via commercially available ELISA kits (pmol/L).
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.
Appetite-inhibiting hormone CCK to be measured via commercially available ELISA kits (pg/ml).
29 secondary outcomes
Appetite perceptions
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Food Preferences
Time frame: 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
Time frame: At the end of each in-lab session (exercise and seated rest; 2 meals total).
Free-living energy intake
Time frame: Day before, day of, and day after each in-lab session (6 days total).
Energy expenditure
Time frame: Day before, day of, and day after each in-lab session (6 days total).
Estradiol
Time frame: Pre-exercise only.
Progesterone
Time frame: Pre-exercise only.
Testosterone
Time frame: Pre-exercise only.
Blood glucose
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Insulin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
C-Peptide
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Peripheral Blood Mononuclear Cells
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Inflammatory Cytokines
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Brain-derived Neurotrophic Factor (BDNF)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Cathepsin B
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Irisin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Klotho
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Adrenocorticotropic Hormone
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Dickkopf-1 (DKK-1)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Fibroblast Growth Factor 23 (FGF-23)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin 1B (IL-1B)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin-6 (IL-6)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Tumor Necrosis Factor (TNF)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteocalcin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteopontin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteoprotegerin (OPG)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Parathyroid Hormone (PTH)
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Sclerostin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Leptin
Time frame: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data from this research study will be available to researchers upon review and approval of reasonable requests starting six months after manuscript publication. Proposals should be sent to the corresponding author.
Related trials for Energy Balance
RecruitingPhase 4
Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Recruiting
Lifestyle Intervention to Improve Muscle Function in Older Adults
Body Composition, Physical Function
Active, not recruiting
Food Genetics Behavior Study
Obesity, Childhood
Recruiting
Effects of Ultra Processed Food on Intestinal Energy Harvest
Obesity and Overweight
Recruiting
Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
Lower Limb Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tom J Hazell, PhD principal investigator
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol Only, Progesterone Only and Estradiol and Progesterone Combination in people with Energy Balance and Physiology - Regulation of Appetite and Food Intake, run by Wilfrid Laurier University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Tucker, MKin, PhD Candidate (519-884-1970 ext. 4919, tuck5010@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.