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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Placebo Comparator
  See description of intervention arm.
• Препарат Estradiol Only
  See description of intervention arm.
• Препарат Progesterone Only
  See description of intervention arm.
• Препарат Estradiol and Progesterone Combination
  See description of intervention arm.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Appetite perceptions [Срок оценки: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.]
• Food Preferences [Срок оценки: 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 [Срок оценки: At the end of each in-lab session (exercise and seated rest; 2 meals total).]
• Free-living energy intake [Срок оценки: Day before, day of, and day after each in-lab session (6 days total).]
• Energy expenditure [Срок оценки: Day before, day of, and day after each in-lab session (6 days total).]
• Estradiol [Срок оценки: Pre-exercise only.]
• Progesterone [Срок оценки: Pre-exercise only.]
• Testosterone [Срок оценки: Pre-exercise only.]
• Blood glucose [Срок оценки: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.]
• Insulin [Срок оценки: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.]
• C-Peptide [Срок оценки: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.]
• Peripheral Blood Mononuclear Cells [Срок оценки: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 1 центр

• Energy Metabolism Research Laboratory — Waterloo

Идентификаторы

NCT: NCT07620587 · EMRL-25-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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