Effect of Bicycle Ergometer Training on Fat Tissue Amount and Metabolism

August 6, 2026 updated by: Şule ŞİMŞEK, Pamukkale University

Effect of Bicycle Ergometer Training in Thermoneutral and Lightly Cold Ambient Temperatures on Fat Tissue Amount and Metabolism in Overweight and Obese Women

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will examine the effects of 12 weeks of endurance training on a bicycle ergometer at thermoneutral and slightly cold ambient temperatures on body composition, subcutaneous and visceral fat tissue thickness, and levels of irisin, leptin, adiponectin, apelin, IL-6 and FGF-21 in the blood of overweight and obese women.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Şule Şimşek, Ass. Prof.
  • Phone Number: 05058099914
  • Email: sules@pau.edu.tr

Study Locations

  • Turkey (Türkiye)
    • Sarayköy
      • Denizli, Sarayköy, Turkey (Türkiye), 09200
        • Şule Şimşek

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Case group 1
participants trained in termoneutral ambient temperature
Other: endurance training with bicycle ergometer in termoneutral ambient temperature
trained with bicycle ergometer three times a week for three months.
Active Comparator: Case group 2
participants trained in lightly cold ambient temperature
Other: endurance training with bicycle ergometer in lightly cold ambient temperature
trained with bicycle ergometer three times a week for three months.
No Intervention: control group
participants do not trained

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rate of BMI
Time Frame: baseline/ through study completion, an average 3 months
assesed with height and body weight
baseline/ through study completion, an average 3 months
analysis of biyoelectric impedans Bioelectrical impedance analysis
Time Frame: baseline/ through study completion, an average 3 months
assesed with with a Tanita BC 418 brand device.
baseline/ through study completion, an average 3 months
rate of subcutaneous and visceral adipose tissue thickness
Time Frame: baseline/ through study completion, an average 3 months
assesed with Ultrasonography
baseline/ through study completion, an average 3 months
Waist circumference Waist hip ratio
Time Frame: baseline/ through study completion, an average 3 months
Waist circumference will be measured with a tape measure.
baseline/ through study completion, an average 3 months
concentration of serum irisin
Time Frame: baseline/ through study completion, an average 3 months
assesed with blood analysis
baseline/ through study completion, an average 3 months
concentration of serum adiponectin
Time Frame: baseline/ through study completion, an average 3 months
assesed with blood analysis
baseline/ through study completion, an average 3 months
concentration of serum apelin
Time Frame: baseline/ through study completion, an average 3 months
assesed with blood analysis
baseline/ through study completion, an average 3 months
concentration of serum IL-6
Time Frame: baseline/ through study completion, an average 3 months
assesed with blood analysis
baseline/ through study completion, an average 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pamukkale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ummuhan Baş Aslan, Prof. Dr., Prof. Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23.07.2024/13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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