- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06208475
Different Menstrual Cycle in Eating Behavior Following Resistance Exercise
June 6, 2024 updated by: National Taiwan Normal University
The Effects of Resistance Exercise on Appetite Control, Food Reward, and Energy Intake in Different Menstrual Cycles
The study aims to provide insights into how menstrual cycle phases impact appetite responses to resistance exercise in young women.
Healthy young women will participate in four trials: the exercise session in the follicular phase, the exercise session in the luteal phase, the control session in the follicular phase, and the control session in the luteal phase.
Various measurements will be taken, including subjective appetite perceptions, appetite hormones, food preferences, lactate levels, estradiol levels, progesterone levels, and energy intake.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 106
- National Taiwan Normal University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age: 20-30
- Healthy female with normal menstruation
- Weight stable for at least 6 months
Exclusion Criteria:
- Overweight (BMI > 30 kg/m^2 or body fat > 30%)
- Hypertension (> 140/90 mmHg)
- Cardiovascular disease, cancer or other chronic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
|---|---|
|
Experimental: The exercise in the follicular phase (EF)
Resistance exercise during the early-follicular phase (approximately during days 1-7 of the menstrual cycle).
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Resistance exercises in the following order: squat, bench press, deadlift.
Each exercise consisted of 3 sets with 7 repetitions, using a load of 70% 1RM with 120sec of rest between sets.
|
|
Experimental: The exercise in the luteal phase (EL)
Resistance exercise during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle).
|
Resistance exercises in the following order: squat, bench press, deadlift.
Each exercise consisted of 3 sets with 7 repetitions, using a load of 70% 1RM with 120sec of rest between sets.
|
|
No Intervention: The control in the follicular phase (CF)
Sit and rest during the early-follicular phase (approximately during days 1-7 of the menstrual cycle).
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|
|
No Intervention: The control in the luteal phase (CL)
Sit and rest during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite
Time Frame: 4 hours during each study intervention
|
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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4 hours during each study intervention
|
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Change in acyl-Ghrelin
Time Frame: 4 hours during each study intervention
|
acyl-Ghrelin in pg/mL
|
4 hours during each study intervention
|
|
Change in total-Ghrelin
Time Frame: 4 hours during each study intervention
|
total-Ghrelin in pg/mL
|
4 hours during each study intervention
|
|
Change in PYY
Time Frame: 4 hours during each study intervention
|
PYY in pg/mL
|
4 hours during each study intervention
|
|
Change in active-GLP-1
Time Frame: 4 hours during each study intervention
|
active-GLP-1 in pg/mL
|
4 hours during each study intervention
|
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Change in total-GLP-1
Time Frame: 4 hours during each study intervention
|
total-GLP-1 in pg/mL
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4 hours during each study intervention
|
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Change in lactate
Time Frame: 4 hours during each study intervention
|
insulin in mmol/L
|
4 hours during each study intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explicit liking
Time Frame: 4 hours during each study intervention
|
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."
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4 hours during each study intervention
|
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Explicit wanting
Time Frame: 4 hours during each study intervention
|
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."
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4 hours during each study intervention
|
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Implicit wanting
Time Frame: 4 hours during each study intervention
|
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.
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4 hours during each study intervention
|
|
Relative preference
Time Frame: 4 hours during each study intervention
|
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 relative preference is the sum of the times each type of food is chosen, with a maximum value of 48 and a minimum value of 0.
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4 hours during each study intervention
|
|
Fat appeal bias
Time Frame: 4 hours during each study intervention
|
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.
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4 hours during each study intervention
|
|
Taste appeal bias
Time Frame: 4 hours during each study intervention
|
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.
|
4 hours during each study intervention
|
|
Change in TG
Time Frame: 4 hours during each study intervention
|
TG in mg/dL
|
4 hours during each study intervention
|
|
Change in glucose
Time Frame: 4 hours during each study intervention
|
glucose in mg/dL
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4 hours during each study intervention
|
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Change in insulin
Time Frame: 4 hours during each study intervention
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insulin in mU/L
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4 hours during each study intervention
|
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Sex hormones
Time Frame: 4 hours during each study intervention
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Sex hormones will be measured, such as estrogen and progesterone
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4 hours during each study intervention
|
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Energy intake
Time Frame: 3 days during each study intervention
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Participants will be required to record their diet for the day before, the current day, and the day following the experiment.
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3 days during each study intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hung-wen Liu, Ph.D., National Taiwan Normal University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Actual)
June 6, 2024
Study Completion (Actual)
June 6, 2024
Study Registration Dates
First Submitted
January 4, 2024
First Submitted That Met QC Criteria
January 15, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
June 7, 2024
Last Update Submitted That Met QC Criteria
June 6, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 202303HM002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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