- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06961734
- Original Trial
Fatmax Exercise in Menstrual Phases: Effects on Fat Metabolism & Body Composition in NWO Women
May 6, 2025 updated by: Beijing Sport University
Effects of a Fatmax Exercise Intervention During Different Menstrual Cycle Phases on Fat Metabolism and Body Composition in Normal Weight Obese Women
Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized clinical trial of single-blind with 3 arms (control group , follicular group and luteal group), in which a pre-treatment-posttest design has been used.
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
-
Beijing, China
- School of Sports Medicine and Rehabilitation, Beijing Sport University
-
-
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:
- Criteria: Inclusion Criteria:
- Female, aged between 18 and 30 years old;
- BMI between 18.5 and 24.9 kg/m2 with a BF% > 30% (normal weight obesity determination criteria);
- Regular menstrual cycles for at least 3 months;
- No use of oral contraceptives for at least 6 months before the experiment;
- Non-smoker and non-alcohol abuser.
Exclusion Criteria:
- The presence of CVD;
- A diagnosis of cancer, pulmonary diseases, or other conditions that prevent participation in exercise;
- The use of medications affecting body composition or metabolism.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
|
Exercised at Fatmax intensity four times per week.
|
|
Active Comparator: follicular group
|
Exercised at Fatmax intensity four times per week and plus three additional exercise during the late follicular phase of each cycle.
|
|
Active Comparator: luteal group
|
Exercised at Fatmax intensity four times per week and plus three additional exercise during the mid- luteal phase of each cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lipid profile
Time Frame: 8 weeks
|
The changes of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, and triglyceride before and after intervention.
|
8 weeks
|
|
Body Fat Mass
Time Frame: 8 weeks
|
Body fat mass (kg) will be assessed using dual-energy X-ray absorptiometry (DXA) scans.
The change of body fat mass before and after intervention.
|
8 weeks
|
|
Percentage of Body Fat
Time Frame: 8 weeks
|
The change of percentage of body fat before and after intervention.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Waist Circumference
Time Frame: 8 weeks
|
The change of waist circumference before and after intervention.
|
8 weeks
|
|
Hip Circumference
Time Frame: 8 weeks
|
The change of hip circumference before and after intervention.
|
8 weeks
|
|
Body Mass Index (BMI)
Time Frame: 8 weeks
|
Changes in Body mass index before and after Intervention.
Body mass index is calculated from the formula, Weight (kg) / Height2 (m2), its unit is kg/m2.
|
8 weeks
|
|
Apolipoprotein A-I (g/L)
Time Frame: 8 weeks
|
The change in apolipoprotein A-I levels before and after the intervention.
|
8 weeks
|
|
Apolipoprotein B (g/L)
Time Frame: 8 weeks
|
The change in apolipoprotein B levels before and after the intervention.
|
8 weeks
|
|
Maximal Oxygen uptake (VO2max)
Time Frame: 8 weeks
|
Changes in Maximal Oxygen uptake before and after Intervention.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 23, 2023
Primary Completion (Actual)
October 30, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
April 20, 2025
First Submitted That Met QC Criteria
May 6, 2025
First Posted (Actual)
May 8, 2025
Study Record Updates
Last Update Posted (Actual)
May 8, 2025
Last Update Submitted That Met QC Criteria
May 6, 2025
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- EFEIDDMCPFMBCNWOW
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
product manufactured in and exported from the U.S.
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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