Muscle DamageNCT06086691
Effect of Strength Versus Endurance Training on Muscle Damage in Gym Athletes on Caffeine Supplementation.
A study testing Strength Training with Caffeine and Endurance Training with Caffeine in people with Muscle Damage, run by Riphah International University at 1 site in Pakistan.
Trial summary
Dietary supplements to enhance exercise and athletic performance come in a variety of forms, including tablets, capsules, liquids, powders, and bars. Many of these products contain numerous ingredients in varied combinations and amounts. Among the more common ingredients are amino acids, protein, creatine, and caffeine Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- Strength Training with Caffeine and Endurance Training with Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jan 2022to 31 Jan 2023
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male gym athletes
- Age: 18-40 years
- Athletes with at least three days training session per week
Who cannot join
- Athletes already on caffeine supplementation
- Athletes with above normal serum enzyme levels
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University (RIU)
Islamabad, Islamabad, 44000
About this study
Dietary supplements to enhance exercise and athletic performance come in a variety of forms, including tablets, capsules, liquids, powders, and bars. Many of these products contain numerous ingredients in varied combinations and amounts. Among the more common ingredients are amino acids, protein, creatine, and caffeine
Read the detailed description
Caffeine is a popular nutritional supplement among gym athletes. It is frequently used as an ergogenic aid to improve physical performance, delay fatigue, and increase muscle power. This research aims to evaluate the effectiveness of caffeine through the blood sample test (Serum CK, LDH levels, AST levels) on muscle damage of gym athletes who are performing aerobic and strength training. This study would help understand the effects of strength training and endurance training on muscle damage in gym athletes who are consuming caffeine and to check the serum enzymes level of both groups who are on strength training and those who are on endurance level training, therefore, this study would help determine which athletes should be careful while consuming caffeine for a particular exercise regimen
- Conditions
- Muscle Damage
- Being tested
- Strength Training with Caffeine, Endurance Training with Caffeine
- Keywords
- Caffeine, Creatine Kinase, Endurance Training, Fitness Centers, Skeletal Muscle, Strength Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength Training with CaffeineOther
The intervention protocol consists of 5 types of strength training exercises. The following exercises will be performed for the strength training group:
- bench press (3 sets of 10 reps)
- biceps curl (3 sets of 10 reps)
- triceps pushdown (3 sets of 10 reps)
- leg press (3 sets of 10 reps)
- leg extension (3 sets of 10 reps)
Strength training would be performed in 3 sets of 10 repetitions with 2 minutes of rest between each exercise. This protocol will be performed in a 30-40-minute session. 10-15 minutes of light warm-up activities will be performed before the start of each exercise session. The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.
Endurance Training with CaffeineOther
The intervention protocol consists of 3 types of endurance training exercises. The following exercises will be performed by this group:
- Cycling (15 min)
- Running (20 min)
- Rowing (10 min)
The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Strength Training | Experimental | Strength training exercises along with caffeine supplementation Receives: Other: Strength Training with Caffeine |
| Endurance Training | Active comparator | Endurance training exercises along with caffeine supplementation Receives: Other: Endurance Training with Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CK Levels
Serum CK level is the amount of an enzyme called creatine kinase (CK) in the blood. CK is a type of protein present in the muscle cells in human body need which is essential for proper functioning. Levels of CK can rise after a heart attack, skeletal muscle injury, or strenuous exercise
Measured: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Serum LDH levels
Lactate Dehydrogenase (LDH) is enzyme found in almost every cell of the human body, including your blood, muscles, brain, kidneys, and pancreas.
Measured: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Serum AST levels
Aspartate aminotransferase (AST) are enzymes found mainly in the liver, but also found in red blood cells, heart cells, muscle tissue and other organs, such as the pancreas and kidneys.
Measured: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Secondary outcomes (1)
Rating of fatigue scale/Numeric Rating Scale-Fatigue
This rating-of-fatigue (ROF) scale has been developed which can track the intensity of perceived fatigue in a variety of contexts.
Measured: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start12 Jan 2022
- Primary completion30 Nov 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Randomized Crossover Trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noman Sadiq, MS-SPT, Principal investigator, Riphah International University, Islamabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086691
- Sponsor's protocol ID
- REC/01241 Mian Waleed Ahmed
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strength Versus Endurance Training on Muscle Damage in Gym Athletes on Caffeine Supplementation.
- ClinicalTrials.gov ID
- NCT06086691
- Acronym / sponsor ID
- REC/01241 Mian Waleed Ahmed
- Conditions
- Muscle Damage
- Keywords
- Caffeine, Creatine Kinase, Endurance Training, Fitness Centers, Skeletal Muscle, Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 17 Oct 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.
Dietary supplements to enhance exercise and athletic performance come in a variety of forms, including tablets, capsules, liquids, powders, and bars. Many of these products contain numerous ingredients in varied combinations and amounts. Among the more common ingredients are amino acids, protein, creatine, and caffeine
Detailed description
Caffeine is a popular nutritional supplement among gym athletes. It is frequently used as an ergogenic aid to improve physical performance, delay fatigue, and increase muscle power. This research aims to evaluate the effectiveness of caffeine through the blood sample test (Serum CK, LDH levels, AST levels) on muscle damage of gym athletes who are performing aerobic and strength training. This study would help understand the effects of strength training and endurance training on muscle damage in gym athletes who are consuming caffeine and to check the serum enzymes level of both groups who are on strength training and those who are on endurance level training, therefore, this study would help determine which athletes should be careful while consuming caffeine for a particular exercise regimen
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Crossover Trial
| Arm | Type | Receives |
|---|---|---|
| Strength Training | Experimental | Other: Strength Training with CaffeineStrength training exercises along with caffeine supplementation |
| Endurance Training | Active comparator | Other: Endurance Training with CaffeineEndurance training exercises along with caffeine supplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male gym athletes
- Age: 18-40 years
- Athletes with at least three days training session per week
Key exclusion criteria (2 listed)
- Athletes already on caffeine supplementation
- Athletes with above normal serum enzyme levels
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 |
|---|---|---|
| Strength Training with CaffeineThe intervention protocol consists of 5 types of strength training exercises. The following exercises will be performed for the strength training group: 1. bench press (3 sets of 10 reps) 2. biceps curl (3 sets of 10 reps) 3. triceps pushdown (3 sets of 10 reps) 4. leg press (3 sets of 10 reps) 5. leg extension (3 sets of 10 reps) Strength training would be performed in 3 sets of 10 repetitions with 2 minutes of rest between each exercise. This protocol will be performed in a 30-40-minute session. 10-15 minutes of light warm-up activities will be performed before the start of each exercise session. The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions. | Other | Strength Training |
| Endurance Training with CaffeineThe intervention protocol consists of 3 types of endurance training exercises. The following exercises will be performed by this group: 1. Cycling (15 min) 2. Running (20 min) 3. Rowing (10 min) The intervention sessions would be carried out with a 3-5-day gap between the two intervention sessions. | Other | Endurance Training |
Primary outcome
Serum CK Levels
Time frame: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Serum CK level is the amount of an enzyme called creatine kinase (CK) in the blood. CK is a type of protein present in the muscle cells in human body need which is essential for proper functioning. Levels of CK can rise after a heart attack, skeletal muscle injury, or strenuous exercise
Serum LDH levels
Time frame: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Lactate Dehydrogenase (LDH) is enzyme found in almost every cell of the human body, including your blood, muscles, brain, kidneys, and pancreas.
Serum AST levels
Time frame: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
Aspartate aminotransferase (AST) are enzymes found mainly in the liver, but also found in red blood cells, heart cells, muscle tissue and other organs, such as the pancreas and kidneys.
1 secondary outcome
Rating of fatigue scale/Numeric Rating Scale-Fatigue
Time frame: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention
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 13 Nov 2023.
- 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.
Noman Sadiq, MS-SPT principal investigator
Riphah International University, Islamabad.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training with Caffeine and Endurance Training with Caffeine in people with Muscle Damage, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 2 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 13 Nov 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 Pakistan. 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?
Serum CK Levels (time frame: Pre-intervention, after 24 hours of the intervention, after 3 days before second intervention, and after 24 hours of the second intervention). 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 13 Nov 2023.