Cognitive ImpairmentNCT07341568
Exercise-Modulated Cognitive Hormones
An observational study of Cognitive Impairment and Healthy Participants, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Healthy Participants
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jun 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Impairment, Healthy Participants
- Keywords
- cognitive capacity, Leptin, Irisin, BDNF hormones
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cognitive abilities
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.
Measured: 6 months
2- Leisure-time physical activity (LTPA)
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
Measured: 6 months
3-Assessment of apoptotic-related proteins
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.
Measured: 6 month
Secondary outcomes (1)
biochemical analysis of hormones, antioxidant enzymes, before and after exercise training
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
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Jun 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Gabr, King Saud University
- Investigators
- Sami Gabr, Principal investigator, Medical Microbiology Dept, ImmunityUnit,Faculty of Medicine, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341568
- Sponsor's protocol ID
- RRC-2023-029
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin and Irisin Hormonal Crosstalk in Cognitive Health Among Aging Individuals: The Modulatory Role of Exercise
- ClinicalTrials.gov ID
- NCT07341568
- Acronym / sponsor ID
- RRC-2023-029
- Conditions
- Cognitive Impairment, Healthy Participants
- Keywords
- cognitive capacity, Leptin, Irisin, BDNF hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
1 secondary outcome
biochemical analysis of hormones, antioxidant enzymes, before and after exercise training
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sami Gabr principal investigator
Medical Microbiology Dept, ImmunityUnit,Faculty of Medicine, Mansoura University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Healthy Participants, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cognitive abilities (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.