- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07341568
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
-
-
Riyadh, Saudi Arabia
- King Saud University
-
-
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
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 |
|---|
|
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
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
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
Investigators
- 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)
June 15, 2025
Primary Completion (Actual)
October 30, 2025
Study Completion (Actual)
November 30, 2025
Study Registration Dates
First Submitted
January 6, 2026
First Submitted That Met QC Criteria
January 6, 2026
First Posted (Actual)
January 14, 2026
Study Record Updates
Last Update Posted (Actual)
January 14, 2026
Last Update Submitted That Met QC Criteria
January 6, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Cognitive Impairment
-
Stanford UniversityRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of EdinburghNHS LothianNot yet recruitingCognitive Impairment | Anesthesia | Cognitive Impairment, Mild | Anesthesia Brain Monitoring | Cognitive Impairment, Progressive | Anesthesia Depth MonitoringUnited Kingdom
-
Fondazione Don Carlo Gnocchi OnlusUniversity of Florence; Consorzio di Bioingeneria e Informatica Medica; Gutenberg...CompletedCognitive Dysfunction | Mild Cognitive Impairment | Vascular Cognitive ImpairmentItaly
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
-
Universidad de ZaragozaRecruitingMild Cognitive Impairment | Randomized Controlled Trial | Subjective Cognitive ImpairmentSpain
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Region SkaneLund University; Berry LabCompletedMemory Impairment | Cognitive Impairment, MildSweden
-
Sunnybrook Health Sciences CentreRecruitingMild Cognitive Impairment | Vascular Cognitive ImpairmentCanada
-
University of HawaiiRecruitingMild Cognitive Impairment | Subjective Cognitive ImpairmentUnited States
-
University of GeorgiaApplied Universal Dynamics, Corp.; Van Robotics, Inc.Active, not recruitingRobot-assisted Cognitive Training for Lonely Older Adults With Mild Cognitive Impairment (MCI) (MCI)Cognitive Change | Aging | Cognitive Impairment, MildUnited States