Liver FunctionsNCT05704608
Effects of Aerobic Training Program On Liver Functions
A study testing Aerobic training in people with Liver Functions, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. Read more about this study
- Who is it for?
- Ages 21 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Liver Functions
- What is being tested?
- Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Sep 2021to 30 Nov 2022
- Phase
- Interventional
- 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 21 to 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age: 21-24 years
- Healthy
- Athletes
Who cannot join
- history of severe illness,
- surgery, or damage to liver,
- fatty liver disease,
- cirrhosis,
- blood infections,
- neuromuscular illnesses,
- or the presence of any disorders such as fever, high blood pressure, high blood sugar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Aerobic Training Program on Liver Functions in Male Athletes - a Randomized Controlled Trial
The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. It becomes necessary to maintain the enzymes of the liver at an optimal level so that liver cells can be protected from inflammation or damage. This paper investigated the effects of a twelve-week aerobic exercise program on the liver function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were recruited for this study and kept in two equal groups. The control group was kept under rigorous supervision and did not participate in any special activities. The experiment group was well-versed in their assigned training program and solely performed the experimental procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control groups was carried out before and after the treatment program by measuring the levels of (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin, and Total protein) respectively using standard methods by collecting blood samples, 5 mls each of baseline into lithium heparin containers for estimation of above biochemical parameters at the pathology laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories accredited (NABL, India).
- Conditions
- Liver Functions
- Being tested
- Aerobic training
- Keywords
- Fatty liver, Physical activity, Treadmill, Exercises
- Medical subject headings
- Fatty Liver, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Exercises on a treadmill at different speeds and inclination were performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Aerobic training program was performed by participants. Receives: Other: Aerobic training |
| Control group | No intervention | No intervention was performed by the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilirubin-Total
Blood level of Bilirubin-Total was measured.
Measured: 12 weeks.
Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT)
Blood level of Serum AST/SGOT was measured.
Measured: 12 weeks.
Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT)
Blood level of Serum ALT/SGPT was measured.
Measured: 12 weeks.
Alkaline Phosphatase
Blood level of Alkaline Phosphatase was measured.
Measured: 12 weeks.
Protein-Total
Blood level of Protein-Total was measured.
Measured: 12 weeks.
Albumin
Blood level of Albumin was measured.
Measured: 12 weeks.
Globulin
Blood level of Globulin was measured.
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Sep 2021
- Primary completion14 Jul 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FunctionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, M.P.Th, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704608
- Sponsor's protocol ID
- DN 4900 /FSS
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Aerobic Training Program on Liver Functions in Male Athletes - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05704608
- Acronym / sponsor ID
- DN 4900 /FSS
- Conditions
- Liver Functions
- Keywords
- Fatty liver, Physical activity, Treadmill, Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 Jan 2023 (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.
The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. It becomes necessary to maintain the enzymes of the liver at an optimal level so that liver cells can be protected from inflammation or damage. This paper investigated the effects of a twelve-week aerobic exercise program on the liver function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were recruited for this study and kept in two equal groups. The control group was kept under rigorous supervision and did not participate in any special activities. The experiment group was well-versed in their assigned training program and solely performed the experimental procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control groups was carried out before and after the treatment program by measuring the levels of (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin, and Total protein) respectively using standard methods by collecting blood samples, 5 mls each of baseline into lithium heparin containers for estimation of above biochemical parameters at the pathology laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories accredited (NABL, India).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Aerobic trainingAerobic training program was performed by participants. |
| Control group | No intervention | –No intervention was performed by the participants. |
Who may qualify
- Ages
- 21 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age: 21-24 years
- Healthy
- Athletes
Key exclusion criteria (7 listed)
- history of severe illness,
- surgery, or damage to liver,
- fatty liver disease,
- cirrhosis,
- blood infections,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingExercises on a treadmill at different speeds and inclination were performed. | Other | Experimental Group |
Primary outcome
Bilirubin-Total
Time frame: 12 weeks.
Blood level of Bilirubin-Total was measured.
Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT)
Time frame: 12 weeks.
Blood level of Serum AST/SGOT was measured.
Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT)
Time frame: 12 weeks.
Blood level of Serum ALT/SGPT was measured.
Alkaline Phosphatase
Time frame: 12 weeks.
Blood level of Alkaline Phosphatase was measured.
Protein-Total
Time frame: 12 weeks.
Blood level of Protein-Total was measured.
Albumin
Time frame: 12 weeks.
Blood level of Albumin was measured.
Globulin
Time frame: 12 weeks.
Blood level of Globulin was measured.
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 30 Jan 2023.
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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.
Masood Khan, M.P.Th principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Liver Functions, 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 4 inclusion and 7 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 30 Jan 2023. 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?
Bilirubin-Total (time frame: 12 weeks.). The study lists 7 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 30 Jan 2023.