The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-30
SponsorWilfrid Laurier University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ages 18-30 years
deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
non-smoking
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo Comparator
DrugSee description of intervention arm.
Estradiol Only
DrugSee description of intervention arm.
Progesterone Only
DrugSee description of intervention arm.
Estradiol and Progesterone Combination
DrugSee description of intervention arm.
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: Placebo ComparatorPlacebo comparator 1 intervention
Group B: Estradiol OnlyExperimental treatment 1 intervention
Group C: Progesterone OnlyExperimental treatment 1 intervention
Group D: Estradiol and Progesterone ComboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).2
Acylated Ghrelin
Appetite-stimulating hormone acylated ghrelin to be measured via commercially available ELISA kits (pg/mL).
Time frame
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.3
Glucagon-like Peptide 1 (GLP-1)
Appetite-inhibiting hormone GLP-1 to be measured via commercially available ELISA kits (pmol/L).
Time frame
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.4
Cholecystokinin (CCK)
Appetite-inhibiting hormone CCK to be measured via commercially available ELISA kits (pg/ml).
Time frame
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.Secondary outcomes
1
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?").
Time frame
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.2
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.
Time frame
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.3
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 .
Time frame
At the end of each in-lab session (exercise and seated rest; 2 meals total).4
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.
Time frame
Day before, day of, and day after each in-lab session (6 days total).Sponsors and contacts
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Source ClinicalTrials.gov