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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06208475
Other study ID # 202303HM002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date June 6, 2024

Study information

Verified date June 2024
Source National Taiwan Normal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 6, 2024
Est. primary completion date June 6, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 30 Years
Eligibility 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 Design


Intervention

Other:
Resistance exercise
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.

Locations

Country Name City State
Taiwan National Taiwan Normal University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan Normal University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in acyl-Ghrelin acyl-Ghrelin in pg/mL 4 hours during each study intervention
Primary Change in total-Ghrelin total-Ghrelin in pg/mL 4 hours during each study intervention
Primary Change in PYY PYY in pg/mL 4 hours during each study intervention
Primary Change in active-GLP-1 active-GLP-1 in pg/mL 4 hours during each study intervention
Primary Change in total-GLP-1 total-GLP-1 in pg/mL 4 hours during each study intervention
Primary Change in lactate insulin in mmol/L 4 hours during each study intervention
Secondary 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." 4 hours during each study intervention
Secondary 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." 4 hours during each study intervention
Secondary 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. 4 hours during each study intervention
Secondary 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. 4 hours during each study intervention
Secondary 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. 4 hours during each study intervention
Secondary 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. 4 hours during each study intervention
Secondary Change in TG TG in mg/dL 4 hours during each study intervention
Secondary Change in glucose glucose in mg/dL 4 hours during each study intervention
Secondary Change in insulin insulin in mU/L 4 hours during each study intervention
Secondary Sex hormones Sex hormones will be measured, such as estrogen and progesterone 4 hours during each study intervention
Secondary Energy intake Participants will be required to record their diet for the day before, the current day, and the day following the experiment. 3 days during each study intervention
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