NCT06961734

Brief Summary

Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

February 23, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
Last Updated

May 8, 2025

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

April 20, 2025

Last Update Submit

May 6, 2025

Conditions

Keywords

aerobic exercisemenstrual cycle phasenormal weight obesitylipid metabolism

Outcome Measures

Primary Outcomes (3)

  • Lipid profile

    The changes of high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, total cholesterol, and triglyceride before and after intervention.

    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.

    8 weeks

  • Percentage of Body Fat

    The change of percentage of body fat before and after intervention.

    8 weeks

Secondary Outcomes (6)

  • Body Mass Index (BMI)

    8 weeks

  • Waist Circumference

    8 weeks

  • Hip Circumference

    8 weeks

  • Apolipoprotein A-I (g/L)

    8 weeks

  • Apolipoprotein B (g/L)

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

follicular group

ACTIVE COMPARATOR
Behavioral: follicular group

luteal group

ACTIVE COMPARATOR
Behavioral: luteal group

Control group

ACTIVE COMPARATOR
Behavioral: Control group

Interventions

Exercised at Fatmax intensity four times per week and plus three additional exercise during the late follicular phase of each cycle.

follicular group
luteal groupBEHAVIORAL

Exercised at Fatmax intensity four times per week and plus three additional exercise during the mid- luteal phase of each cycle.

luteal group
Control groupBEHAVIORAL

Exercised at Fatmax intensity four times per week.

Control group

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2025

First Posted

May 8, 2025

Study Start

February 23, 2023

Primary Completion

October 30, 2023

Study Completion

December 31, 2023

Last Updated

May 8, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations