NCT07659392

Brief Summary

The primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Specifically, the study aims to compare changes in lipid oxidation before and after the intervention between women with polycystic ovary syndrome and those without polycystic ovary syndrome. The secondary objectives are to assess the impact of polycystic ovary syndrome on several physiological and metabolic parameters in women with overweight or obesity. These include: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during a walking exercise; (iv) body composition, glycemic and lipid profiles, and circulating levels of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness. In addition, the effect of the multidisciplinary intervention, including the adapted physical activity program, will be evaluated on these same outcomes: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during walking exercise; (iv) body composition, glycemic and lipid profiles, and concentrations of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness, in women with overweight or obesity, with or without polycystic ovary syndrome.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
28mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Dec 2028

First Submitted

Initial submission to the registry

June 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2.4 years

First QC Date

June 11, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

polycystic ovary syndromewomencardiometabolicPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Lipid oxidation during walking exercise

    Baseline and after 10 weeks of intervention

Secondary Outcomes (38)

  • Energy expenditure at rest

    Baseline and after 10 weeks of intervention

  • Lipid oxidation at rest

    Baseline and after 10 weeks of intervention

  • Carbohydrate oxidation at rest

    Baseline and after 10 weeks of intervention

  • Systolic blood pressure at rest

    Baseline and after 10 weeks of intervention

  • Diastolic blood pressure at rest

    Baseline and after 10 weeks of intervention

  • +33 more secondary outcomes

Study Arms (1)

Physical activity intervention

EXPERIMENTAL
Behavioral: Physical activity

Interventions

Participants will participate to adapted physical activity, supervised by a professional

Physical activity intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 40 years (inclusive boundaries)
  • Women with a body mass index (BMI) between 25 and 40 kg/m²
  • Women performing no more than 150 minutes of moderate-to-vigorous physical activity per week
  • Women able to provide informed consent to participate
  • Women affiliated with a social security system
  • One group will consist of women with polycystic ovary syndrome, and another group will consist of women without polycystic ovary syndrome

You may not qualify if:

  • Pregnancy or breastfeeding, as declared by the participant
  • Postmenopausal women
  • Women currently receiving pharmacological treatment for obesity or who have received such treatment within the past two years
  • Women under legal protection measures (guardianship, curatorship, or judicial protection)
  • Refusal to sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

OverweightObesityPolycystic Ovary SyndromeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: The participants will have different conditions, with or without polycystic ovary syndrome, but will follow the same intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 22, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Internal regulation

Locations