Fat MetabolismNCT06961734
Fatmax Exercise in Menstrual Phases: Effects on Fat Metabolism & Body Composition in NWO Women
A study testing follicular group and luteal group in people with Fat Metabolism, run by Beijing Sport University at 1 site in China.
Trial summary
Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Metabolism
- What is being tested?
- follicular group and luteal group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 31 Dec 2023
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
About this study
Official title: 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
Read the 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.
- Conditions
- Fat Metabolism
- Being tested
- follicular group, luteal group, Control group
- Keywords
- aerobic exercise, menstrual cycle phase, normal weight obesity, lipid metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follicular groupBehavioural
Exercised at Fatmax intensity four times per week and plus three additional exercise during the late follicular phase of each cycle.
luteal groupBehavioural
Exercised at Fatmax intensity four times per week and plus three additional exercise during the mid- luteal phase of each cycle.
Control groupBehavioural
Exercised at Fatmax intensity four times per week.
| Study group | Role | What they receive |
|---|---|---|
| follicular group | Active comparator | Not described Receives: Behavioral: follicular group |
| luteal group | Active comparator | Not described Receives: Behavioral: luteal group |
| Control group | Active comparator | Not described Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid profile
The changes of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, and triglyceride before and after intervention.
Measured: 8 weeks
Body Fat Mass
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.
Measured: 8 weeks
Percentage of Body Fat
The change of percentage of body fat before and after intervention.
Measured: 8 weeks
Secondary outcomes (6)
Body Mass Index (BMI)
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.
Measured: 8 weeks
Waist Circumference
The change of waist circumference before and after intervention.
Measured: 8 weeks
Hip Circumference
The change of hip circumference before and after intervention.
Measured: 8 weeks
Apolipoprotein A-I (g/L)
The change in apolipoprotein A-I levels before and after the intervention.
Measured: 8 weeks
Apolipoprotein B (g/L)
The change in apolipoprotein B levels before and after the intervention.
Measured: 8 weeks
Maximal Oxygen uptake (VO2max)
Changes in Maximal Oxygen uptake before and after Intervention.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start23 Feb 2023
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat MetabolismStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961734
- Sponsor's protocol ID
- EFEIDDMCPFMBCNWOW
- Status last verified
- Feb 2023
- First submitted
- 20 Apr 2025
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fatmax Exercise Intervention During Different Menstrual Cycle Phases on Fat Metabolism and Body Composition in Normal Weight Obese Women
- ClinicalTrials.gov ID
- NCT06961734
- Acronym / sponsor ID
- EFEIDDMCPFMBCNWOW
- Conditions
- Fat Metabolism
- Keywords
- aerobic exercise, menstrual cycle phase, normal weight obesity, lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 May 2025 (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.
Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| follicular group | Active comparator | Behavioral: follicular group |
| luteal group | Active comparator | Behavioral: luteal group |
| Control group | Active comparator | Behavioral: Control group |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| follicular groupExercised at Fatmax intensity four times per week and plus three additional exercise during the late follicular phase of each cycle. | Behavioural | follicular group |
| luteal groupExercised at Fatmax intensity four times per week and plus three additional exercise during the mid- luteal phase of each cycle. | Behavioural | luteal group |
| Control groupExercised at Fatmax intensity four times per week. | Behavioural | Control group |
Primary outcome
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.
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.
Percentage of Body Fat
Time frame: 8 weeks
The change of percentage of body fat before and after intervention.
6 secondary outcomes
Body Mass Index (BMI)
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Hip Circumference
Time frame: 8 weeks
Apolipoprotein A-I (g/L)
Time frame: 8 weeks
Apolipoprotein B (g/L)
Time frame: 8 weeks
Maximal Oxygen uptake (VO2max)
Time frame: 8 weeks
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 8 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follicular group and luteal group in people with Fat Metabolism, run by Beijing Sport University at 1 site in China.
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 6 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 8 May 2025. 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 China. 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?
Lipid profile (time frame: 8 weeks). The study lists 3 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 8 May 2025.