Exercise-Modulated Cognitive Hormones

January 6, 2026 updated by: Sami Gabr, King Saud University

Leptin and Irisin Hormonal Crosstalk in Cognitive Health Among Aging Individuals: The Modulatory Role of Exercise

Investigating the influence of a 12-week exercise regimen structured thrice weekly on cognitive capacity, and related hormones like Leptin, Irisin, BDNF hormones, antioxidant status, and inflammatory cytokines, whether these modulations potentially enhance neuroprotection and mitigate age-related cognitive impairment among healthy adults.

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.

Detailed Description

To elucidate the potential role of exercise as a buffer of cognitive impairment among healthy adults. We thought to investigate the effect of supervised aerobic training of moderate intensity on related hormones like Leptin, Irisin, BDNF hormones, antioxidant status, and inflammatory cytokines, whether these modulations potentially enhance neuroprotection and mitigate age-related cognitive impairment among healthy adults.

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.
Observational

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.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Sixty healthy individuals, aged 50 to 80 years (30 men/30 women), were invited to participate in this study after provided with informed consent.

Description

Inclusion Criteria:

  • Sixty healthy individuals, aged 50 to 80 years (30 men/30 women), were invited to participate in this study after provided with informed consent and were included in this study. Also, all participants were of a sedentary lifestyle, with little or no physical activity during daily routine activities like work and transportation

Exclusion Criteria:

  • To ensure accurate results, participants with obesity (BMI) ≥35 kg/m2.), physical impairments, movement limitations, chronic illnesses, such as kidney or liver diseases, or severe diabetes-related complications such as neuropathy, retinopathy, neuromuscular issues, cardiopulmonary conditions, or disorders affecting eating, the endocrine system, immune system, or mental health or those who undergoing glucocorticoid medication were excluded from this 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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
participants with cognitive impairment
subjects with cognitive imparment as measured by the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) battery.
healthy goup
Subjects are healthy without any diseases and are normal as estimated by the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) battery.

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
Assessment of cognitive abilities
Time Frame: 6 months
Trained research assistants assessed the cognitive abilities of older adult's pre and post supervised aerobic exercise using the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) battery. Assessments required between 45 and 90 minutes.
6 months
2- Leisure-time physical activity (LTPA)
Time Frame: 6 months
A verified questionnaire was utilized to assess physical activity, specifically focusing on leisure-time physical activity (LTPA). In alignment with previous findings, we measured the weekly energy expenditure in terms of metabolic equivalents per hour per week (T-LPTA-MET/H/W
6 months
3-Assessment of apoptotic-related proteins
Time Frame: 6 month
Blood serum samples were collected from all participants in the early hours after a night of fasting, both before and after the exercise training regimen, to analyze apoptosis-related proteins. Immunoassay methods were used to measure serum Bcl-2 and cytochrome c levels. This involved using ELISA kits specifically designed for Bcl-2 (Cat# QIA23, Oncogene Research Products, Germany) and cytochrome c (Zymed ELISA Kit, Cat. No. 99-0040). Furthermore, the quantification of p53 concentration in the serum was determined utilizing a single-step enzyme-immunoassay ELISA kit (Catalog Number 11 828 789 001; Roche Diagnostics GmbH, Roche Applied Science, Germany) based on photometric methods.
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
biochemical analysis of hormones, antioxidant enzymes, before and after exercise training
Time Frame: 6 month
The levels of Leptin, Irisin, BDNF hormones, antioxidant status, and inflammatory cytokines were identified from the serum of all subjects, healthy and cognitively impaired subjects, before and after exercise sessions
6 month

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.
King Saud 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.
  • Principal Investigator: Sami Gabr, Medical Microbiology Dept, ImmunityUnit,Faculty of Medicine, Mansoura University, Egypt

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.
June 15, 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.
October 30, 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.
November 30, 2025

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).
January 6, 2026

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.
January 6, 2026

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.
January 14, 2026

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.
January 14, 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.
January 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.
January 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.
  • RRC-2023-029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings