NCT06208475

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

January 4, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

Early follicular phaseMid-luteal phase

Outcome Measures

Primary Outcomes (7)

  • 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.".

    4 hours during each study intervention

  • Change in acyl-Ghrelin

    acyl-Ghrelin in pg/mL

    4 hours during each study intervention

  • Change in total-Ghrelin

    total-Ghrelin in pg/mL

    4 hours during each study intervention

  • Change in PYY

    PYY in pg/mL

    4 hours during each study intervention

  • Change in active-GLP-1

    active-GLP-1 in pg/mL

    4 hours during each study intervention

  • Change in total-GLP-1

    total-GLP-1 in pg/mL

    4 hours during each study intervention

  • Change in lactate

    insulin in mmol/L

    4 hours during each study intervention

Secondary Outcomes (11)

  • Explicit liking

    4 hours during each study intervention

  • Explicit wanting

    4 hours during each study intervention

  • Implicit wanting

    4 hours during each study intervention

  • Relative preference

    4 hours during each study intervention

  • Fat appeal bias

    4 hours during each study intervention

  • +6 more secondary outcomes

Study Arms (4)

The exercise in the follicular phase (EF)

EXPERIMENTAL

Resistance exercise during the early-follicular phase (approximately during days 1-7 of the menstrual cycle).

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).

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).

Interventions

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.

The exercise in the follicular phase (EF)The exercise in the luteal phase (EL)

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-30
  • Healthy female with normal menstruation
  • Weight stable for at least 6 months

You may not qualify if:

  • Overweight (BMI \> 30 kg/m\^2 or body fat \> 30%)
  • Hypertension (\> 140/90 mmHg)
  • Cardiovascular disease, cancer or other chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hung-Wen Liu, Ph.D.

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 17, 2024

Study Start

August 1, 2023

Primary Completion

June 6, 2024

Study Completion

June 6, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations