- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07444021
Effect of Resistance Exercise on Energy Balance and Appetite Regulation in Males and Females
There is growing evidence that males and females may exhibit different acute responses and long-term adaptations to exercise training. Accordingly, contemporary exercise physiology research increasingly recognizes sex as an important biological variable that may influence appetite regulation and energy balance.
This year's project aims to investigate: (1) appetite regulation and energy balance following acute resistance exercise, and (2) potential sex-based differences in appetite regulation and energy balance in response to resistance exercise.
Understanding both the overall effects of resistance exercise and sex-related variability in these responses is important for improving the physiological interpretation of exercise-induced changes in appetite and energy balance. Such knowledge may help to reduce heterogeneity in exercise research findings and support the development of more precise, evidence-based exercise prescriptions that are applicable to both males and females.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hung-Wen Liu, Ph.D.
- Phone Number: +886 0277496863
- Email: hwliu@ntnu.edu.tw
Study Locations
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Taipei, Taiwan, 106
- Recruiting
- National Taiwan Normal University
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Contact:
- Hung-Wen Liu, Ph.D.
- Phone Number: +886 0277496863
- Email: hwliu@ntnu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy males and females aged 20-30 years
- Females with a regular menstrual cycle
- Stable body weight, defined as no significant change in body weight during the past 6 months
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Obesity, defined as:
- Body mass index (BMI) > 30 kg/m²
- Body fat percentage > 25% in males
- Body fat percentage > 30% in females
- Hypertension, defined as resting blood pressure > 140/90 mmHg
- History of cardiovascular disease
- History of cancer
- History of liver disease
- History of kidney disease
- Presence of any medical condition that may interfere with study outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: males
Resistance exercises are in the following order: squat, bench press, deadlift.
Each exercise consists of 3 sets with 7 repetitions, using a load of 70% 1RM with 120 sec of rest between sets.
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Resistance exercises are in the following order: squat, bench press, deadlift.
Each exercise consists of 3 sets with 7 repetitions, using a load of 70% 1RM with 120 sec of rest between sets.
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No Intervention: males control
Participants remained seated at rest during the control trial.
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Experimental: females exercise
During the early follicular phase, participants performed resistance exercises in the following order: squat, bench press, and deadlift.
Each exercise consisted of three sets of seven repetitions performed at 70% of one-repetition maximum (1RM), with 120 s of rest between sets.
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During the early follicular phase, participants completed a standardized resistance exercise protocol consisting of squat, bench press, and deadlift, performed in a fixed order.
Each exercise comprised three sets of seven repetitions at 70% of one-repetition maximum (1RM), with 120 s of rest between sets.
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No Intervention: females control
During the early follicular phase, participants remained seated at rest during the control trial.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in acyl-Ghrelin
Time Frame: 3 hours during each study intervention
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acyl-Ghrelin in pg/mL
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3 hours during each study intervention
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Change in PYY
Time Frame: 3 hours during each study intervention
|
PYY in pg/mL
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3 hours during each study intervention
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Change in lactate
Time Frame: 3 hours during each study intervention
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lactate in mmol/L
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3 hours during each study intervention
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change in Cortisol
Time Frame: 3 hours during each study intervention
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Cortisol mcg/dL
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3 hours during each study intervention
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Subjective appetite
Time Frame: 3 hours during each study intervention
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The appetite perceptions are obtained through a 0-100 mm visual analog scale.
The variables assessed include perceptions of hunger (i.e., "How hungry do you feel?"), satisfaction (i.e., "How satisfied do you feel?"), fullness (i.e., "How full do you feel?"), prospective food consumption (i.e., "How much do you think you can eat?"), and nausea (i.e., "How nauseous do you feel?"), with 0 indicating "not at all" and 100 signifying "extremely.".
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3 hours during each study intervention
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Energy intake
Time Frame: The Before day, the durning day, and the day following the experiment.
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Participants will be required to record their diet for the day before, the current day (include following exercise ad-libitum), and the day following the experiment.
The energy intake include absolute energy intake and relative energy intake .
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The Before day, the durning day, and the day following the experiment.
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Energy expenditure
Time Frame: The Before day, the durning day, and the day following the experiment.
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Energy expenditure will include resting energy expenditure (REE), exercise energy expenditure, and non-exercise energy expenditure.
REE will be measured using indirect calorimetry (MetaLyzer 3B; VO₂ and VCO₂ exchange).
Exercise energy expenditure will be recorded during the resistance exercise session, and non-exercise energy expenditure will be assessed using an accelerometer.
Total energy expenditure will be calculated as the sum of these components.
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The Before day, the durning day, and the day following the experiment.
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Energy Balance
Time Frame: The Before day, the durning day, and the day following the experiment.
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Energy balance will be calculated as total energy intake (EI) minus total energy expenditure (TEE). Total energy intake will include energy consumed during the laboratory ad-libitum meal and energy intake recorded outside the laboratory during the monitoring period. Total energy expenditure will include resting energy expenditure, exercise energy expenditure, and non-exercise energy expenditure, as previously described. Energy balance will be expressed in kilocalories (kcal), with positive values indicating energy surplus and negative values indicating energy deficit. |
The Before day, the durning day, and the day following the experiment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Leeds food preference questionnaire
Time Frame: 3 hours during each study intervention
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Explicit liking A visual analog scale ranging from 0 to 100 mm is utilized to evaluate the question, "How pleasant would it be to taste some of this food now?" with 0 indicating "not at all" and 100 signifying "extremely." Explicit wanting A visual analog scale ranging from 0 to 100 mm is utilized to evaluate the question, "How much do you want some of this food now?" with 0 indicating "not at all" and 100 signifying "extremely." Implicit wanting Participants are given a set of food image pairs and are asked to select their preference by answering the question, "Which food do you desire the most at the moment?". The implicit wanting calculation involves further consideration of response time data based on preference choices using a standardized equation. Relative preference Participants are given a set of food image pairs and are asked to select their preference by answering the question, "Which food do you desire the most at the moment?". |
3 hours during each study intervention
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Leeds food preference questionnaire
Time Frame: 3 hours during each study intervention
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Taste appeal bias Taste preference (savoury or sweet) is calculated by subtracting the mean savory scores from the mean sweet scores. Positive values suggest a preference for sweet foods, while negative scores indicate a preference for savory foods, and a score of 0 signifies an equal preference between taste categories. Fat appeal bias Fat preference (high or low) is calculated by subtracting the mean low-fat scores from the mean high-fat scores. Positive values suggest a preference for high-fat foods, while negative scores indicate a preference for low-fat or savory foods, and a score of 0 signifies an equal preference between fat content. |
3 hours during each study intervention
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10 Ratings of Perceived Exertion (RPE)
Time Frame: 1-hour during each exercise intervention
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Ratings of Perceived Exertion (RPE) will be assessed using the Borg Category-Ratio 10 (CR10) scale during resistance exercise. The scale ranges from 1 to 10, where 1 indicates very light exertion and 10 indicates maximal exertion. Higher scores represent greater perceived exercise intensity. |
1-hour during each exercise intervention
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Heart rate (HR)
Time Frame: 3-hour during each study intervention
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HR will be measured during each study intervention.
HRV (Heart Rate Variability) will be measured during each study intervention.
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3-hour during each study intervention
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Estradiol (E2)
Time Frame: Baseline for each trial (female participants only).
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Estradiol (E2) concentration in pg/mL, measured from blood samples.
Baseline measurements will be used to confirm menstrual cycle phase for each trial.
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Baseline for each trial (female participants only).
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Progesterone (P4)
Time Frame: Baseline for each trial (female participants only).
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Progesterone (P4) concentration in ng/mL (or nmol/L), measured from blood samples.
Baseline hormone levels will be assessed at each trial.
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Baseline for each trial (female participants only).
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Concentric Peak Velocity
Time Frame: During each exercise condition.
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Concentric peak velocity (m/s) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition.
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Concentric Mean Velocity
Time Frame: During each exercise condition
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Concentric mean velocity (m/s) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition
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Eccentric Peak Velocity
Time Frame: During each exercise condition
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Eccentric peak velocity (m/s) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition
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Concentric Mean Power
Time Frame: During each exercise condition
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Concentric mean power (W) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition
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Relative Concentric Mean Power
Time Frame: During each exercise condition
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Mean concentric power normalized to body mass (W/kg) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition
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Concentric Work
Time Frame: During each exercise condition
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Concentric work (J) will be measured using the Gymaware system during resistance exercise.
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During each exercise condition
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Velocity Loss
Time Frame: During each exercise condition
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Velocity loss (%) across sets during resistance exercise will be calculated using data obtained from the Gymaware system.
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During each exercise condition
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202412HM018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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