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The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance (E2 & P4 in EB)

2026年5月26日 更新者:Tom Hazell、Wilfrid Laurier University
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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Jessica Tucker, MKin, PhD Candidate
  • 电话号码:4919 519-884-1970
  • 邮箱:tuck5010@mylaurier.ca

学习地点

    • Ontario
      • Waterloo、Ontario、加拿大、N2L 3C5
        • 招聘中
        • Energy Metabolism Research Laboratory
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较: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.
See description of intervention arm.
实验性的: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.
See description of intervention arm.
实验性的: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.
See description of intervention arm.
实验性的: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.
See description of intervention arm.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Energy balance
大体时间: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).
Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).
Acylated Ghrelin
大体时间: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).
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)
大体时间: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).
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
Cholecystokinin (CCK)
大体时间: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).
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.

次要结果测量

结果测量
措施说明
大体时间
Appetite perceptions
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
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?").
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Food Preferences
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
For food preferences, a state food preference questionnaire is a survey or questionnaire used to gather information about individuals' food preferences, and dietary habits.
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
大体时间:At the end of each in-lab session (exercise and seated rest; 2 meals total).
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 .
At the end of each in-lab session (exercise and seated rest; 2 meals total).
Free-living energy intake
大体时间:Day before, day of, and day after each in-lab session (6 days total).
Participants will complete a 3 day food record around each in lab session using a mobile application (Keenoa®) monitored by a registered dietician.
Day before, day of, and day after each in-lab session (6 days total).
Energy expenditure
大体时间:Day before, day of, and day after each in-lab session (6 days total).
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.
Day before, day of, and day after each in-lab session (6 days total).
Estradiol
大体时间:Pre-exercise only.
Sex hormone estradiol measured via radioimmunoassay (pg/mL).
Pre-exercise only.
Progesterone
大体时间:Pre-exercise only.
Sex hormone progesterone measured via radioimmunoassay (ng/mL).
Pre-exercise only.
Testosterone
大体时间:Pre-exercise only.
Sex hormone testosterone measured via radioimmunoassay.
Pre-exercise only.
Blood glucose
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Will be measured using biochemical assays prior to and following treatment.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Insulin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Will be measured using biochemical assays prior to and following treatment.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
C-Peptide
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Will be measured using biochemical assays prior to and following treatment.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Peripheral Blood Mononuclear Cells
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Inflammatory Cytokines
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
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)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via ELISA kits.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Cathepsin B
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via ELISA kits.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Irisin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via ELISA kits.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Klotho
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via ELISA kits.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Adrenocorticotropic Hormone
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Dickkopf-1 (DKK-1)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
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)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin 1B (IL-1B)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Interleukin-6 (IL-6)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Tumor Necrosis Factor (TNF)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteocalcin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteopontin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Osteoprotegerin (OPG)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Parathyroid Hormone (PTH)
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Sclerostin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Leptin
大体时间:Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
Measured in blood samples via immunoassays.
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tom J Hazell, PhD、Wilfrid Laurier University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年8月31日

研究完成 (估计的)

2028年8月31日

研究注册日期

首次提交

2026年1月28日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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