MenstruationNCT06208475
Different Menstrual Cycle in Eating Behavior Following Resistance Exercise
A study testing Resistance exercise in people with Menstruation and Energy Balance, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation, Energy Balance, Appetitive Behavior
- What is being tested?
- Resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-30
- Healthy female with normal menstruation
- Weight stable for at least 6 months
Who cannot join
- Overweight (BMI > 30 kg/m^2 or body fat > 30%)
- Hypertension (> 140/90 mmHg)
- Cardiovascular disease, cancer or other chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Menstruation, Energy Balance, Appetitive Behavior, Food Reward
- Being tested
- Resistance exercise
- Keywords
- Early follicular phase, Mid-luteal phase
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The exercise in the follicular phase (EF) | Experimental | Resistance exercise during the early-follicular phase (approximately during days 1-7 of the menstrual cycle). Receives: Other: Resistance exercise |
| The exercise in the luteal phase (EL) | Experimental | Resistance exercise during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle). Receives: Other: Resistance exercise |
| The control in the follicular phase (CF) | No intervention | Sit and rest during the early-follicular phase (approximately during days 1-7 of the menstrual cycle). |
| The control in the luteal phase (CL) | No intervention | Sit and rest during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite
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.".
Measured: 4 hours during each study intervention
Change in acyl-Ghrelin
acyl-Ghrelin in pg/mL
Measured: 4 hours during each study intervention
Change in total-Ghrelin
total-Ghrelin in pg/mL
Measured: 4 hours during each study intervention
Change in PYY
PYY in pg/mL
Measured: 4 hours during each study intervention
Change in active-GLP-1
active-GLP-1 in pg/mL
Measured: 4 hours during each study intervention
Change in total-GLP-1
total-GLP-1 in pg/mL
Measured: 4 hours during each study intervention
Change in lactate
insulin in mmol/L
Measured: 4 hours during each study intervention
Secondary outcomes (11)
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."
Measured: 4 hours during each study intervention
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."
Measured: 4 hours during each study intervention
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.
Measured: 4 hours during each study intervention
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?". 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.
Measured: 4 hours during each study intervention
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.
Measured: 4 hours during each study intervention
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.
Measured: 4 hours during each study intervention
Change in TG
TG in mg/dL
Measured: 4 hours during each study intervention
Change in glucose
glucose in mg/dL
Measured: 4 hours during each study intervention
Change in insulin
insulin in mU/L
Measured: 4 hours during each study intervention
Sex hormones
Sex hormones will be measured, such as estrogen and progesterone
Measured: 4 hours during each study intervention
Energy intake
Participants will be required to record their diet for the day before, the current day, and the day following the experiment.
Measured: 3 days during each study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Aug 2023
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenstruationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hung-Wen Liu, Ph.D., Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208475
- Sponsor's protocol ID
- 202303HM002
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resistance Exercise on Appetite Control, Food Reward, and Energy Intake in Different Menstrual Cycles
- ClinicalTrials.gov ID
- NCT06208475
- Acronym / sponsor ID
- 202303HM002
- Conditions
- Menstruation, Energy Balance, Appetitive Behavior, Food Reward
- Keywords
- Early follicular phase, Mid-luteal phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The exercise in the follicular phase (EF) | Experimental | Other: Resistance exerciseResistance exercise during the early-follicular phase (approximately during days 1-7 of the menstrual cycle). |
| The exercise in the luteal phase (EL) | Experimental | Other: Resistance exerciseResistance exercise during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle). |
| The control in the follicular phase (CF) | No intervention | –Sit and rest during the early-follicular phase (approximately during days 1-7 of the menstrual cycle). |
| The control in the luteal phase (CL) | No intervention | –Sit and rest during the mid-luteal phase (approximately during days 18-25 of the menstrual cycle). |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 20-30
- Healthy female with normal menstruation
- Weight stable for at least 6 months
Key exclusion criteria (3 listed)
- Overweight (BMI > 30 kg/m^2 or body fat > 30%)
- Hypertension (> 140/90 mmHg)
- Cardiovascular disease, cancer or other chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseResistance 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. | Other | The exercise in the follicular phase (EF), The exercise in the luteal phase (EL) |
Primary outcome
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.".
Change in acyl-Ghrelin
Time frame: 4 hours during each study intervention
acyl-Ghrelin in pg/mL
Change in total-Ghrelin
Time frame: 4 hours during each study intervention
total-Ghrelin in pg/mL
Change in PYY
Time frame: 4 hours during each study intervention
PYY in pg/mL
Change in active-GLP-1
Time frame: 4 hours during each study intervention
active-GLP-1 in pg/mL
Change in total-GLP-1
Time frame: 4 hours during each study intervention
total-GLP-1 in pg/mL
Change in lactate
Time frame: 4 hours during each study intervention
insulin in mmol/L
11 secondary outcomes
Explicit liking
Time frame: 4 hours during each study intervention
Explicit wanting
Time frame: 4 hours during each study intervention
Implicit wanting
Time frame: 4 hours during each study intervention
Relative preference
Time frame: 4 hours during each study intervention
Fat appeal bias
Time frame: 4 hours during each study intervention
Taste appeal bias
Time frame: 4 hours during each study intervention
Change in TG
Time frame: 4 hours during each study intervention
Change in glucose
Time frame: 4 hours during each study intervention
Change in insulin
Time frame: 4 hours during each study intervention
Sex hormones
Time frame: 4 hours during each study intervention
Energy intake
Time frame: 3 days during each study intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Wen Liu, Ph.D. principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise in people with Menstruation and Energy Balance, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective appetite (time frame: 4 hours during each study intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.