NCT07263126

Brief Summary

The aim of this study is to investigate the effect of endurance training performed with a bicycle ergometer at different ambient temperatures on the amount of fat tissue and fat tissue metabolism in overweight and obese women.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
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 Progress95%
May 2025May 2026

First Submitted

Initial submission to the registry

May 27, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 27, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2026

Last Updated

December 4, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

May 27, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

Bicycle ErgometerOverweightObese

Outcome Measures

Primary Outcomes (5)

  • rate of BMI

    assesed with height and body weight

    baseline/ through study completion, an average 3 months

  • analysis of biyoelectric impedans Bioelectrical impedance analysis

    assesed with with a Tanita BC 418 brand device.

    baseline/ through study completion, an average 3 months

  • Ratio of waist-hip Waist hip ratio

    Waist and hip circumference will be measured with a tape measure.

    baseline/ through study completion, an average 3 months

  • rate of subcutaneous and visceral adipose tissue thickness

    assesed with Ultrasonography

    baseline/ through study completion, an average 3 months

  • concentration of serum irisin, leptin, adiponectin, apelin, İL-6 and FGF-21

    assesed with blood analysis

    baseline/ through study completion, an average 3 months

Study Arms (3)

Case group 1

EXPERIMENTAL

participants trained in termoneutral ambient temperature

Other: endurance training with bicycle ergometer in termoneutral ambient temperature

Case group 2

ACTIVE COMPARATOR

participants trained in lightly cold ambient temperature

Other: endurance training with bicycle ergometer in lightly cold ambient temperature

control group

NO INTERVENTION

participants do not trained

Interventions

trained with bicycle ergometer three times a week for three months.

Case group 1

trained with bicycle ergometer three times a week for three months.

Case group 2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being female,
  • Being between 20-40 years old,
  • Having a BMI between 25 and 34.9,
  • Having a waist circumference greater than 80 cm,
  • Not having participated in any exercise program in the last 3 months ,
  • Not having experienced a change of more than 10% in body weight in the last 6 months.

You may not qualify if:

  • On a weight loss diet,
  • Having cancer, unstable heart disease, cerebrovascular disease, metabolic disease, diabetes, hypertension, psychiatric disorders, or other conditions or neurological disorders,
  • Having a musculoskeletal disorder or any disease/injury that may affect participation in exercise training,
  • Participating in regular physical activity (at least 150 minutes of moderate-intensity physical activity or 75 minutes of vigorous-intensity physical activity or an equivalent combination of both during the week),
  • Being pregnant or breastfeeding,
  • Having undergone surgery for the treatment of obesity,
  • Receiving pharmacological treatment for obesity. Participants who did not attend more than 20% of the endurance training program will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şule Şimşek

Denizli, Sarayköy, 09200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Otero-Diaz B, Rodriguez-Flores M, Sanchez-Munoz V, Monraz-Preciado F, Ordonez-Ortega S, Becerril-Elias V, Baay-Guzman G, Obando-Monge R, Garcia-Garcia E, Palacios-Gonzalez B, Villarreal-Molina MT, Sierra-Salazar M, Antuna-Puente B. Exercise Induces White Adipose Tissue Browning Across the Weight Spectrum in Humans. Front Physiol. 2018 Dec 11;9:1781. doi: 10.3389/fphys.2018.01781. eCollection 2018.

MeSH Terms

Conditions

OverweightObesity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ummuhan Baş Aslan, Prof. Dr.

    Prof. Dr.

    STUDY DIRECTOR

Central Study Contacts

Şule Şimşek, Ass. Prof.

CONTACT

Ayşe Nur Oymak Soysal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The main outcome measures will be assessed by 3 different researchers . The researchers conducting the assessments will not know which group the participants are belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Endurance training in termoneutral ambient, Endurance training in lightly cold ambient, control group (the waiting list group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

May 27, 2025

First Posted

December 4, 2025

Study Start

May 27, 2025

Primary Completion (Estimated)

May 27, 2026

Study Completion (Estimated)

May 27, 2026

Last Updated

December 4, 2025

Record last verified: 2025-12

Locations