Muscle Strength RecoveryNCT07092722
Efficacy of LN18178 in Improving Muscle Strength, Aerobic Capacity and Body Composition in Healthy Young Males
A study testing LN18178 in people with Muscle Strength Recovery and Endurance, run by GENCOR Lifestage Solutions.
Trial summary
The Purpose of the study is to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males. Read more about this study
- Who is it for?
- Ages 36 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength Recovery, Endurance, Healthy Human Volunteers
- What is being tested?
- LN18178
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 4 Aug 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 36 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Untrained healthy male subjects aged between 36 and 50 years with a Body Mass Index (BMI) between 22 and 27 kg/m2.
- Willingness to do exercise training program during the course of the study.
- Subject considered generally healthy as per health history and routine clinical investigations.
- Ability to understand the risks and benefits of the protocol.
- Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
- Subjects who are sexually active must agree to use adequate non-hormonal contraception during the study
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- Subjects agree to maintain current diet and activity level.
- Subject agrees not to start any new therapies for energy boosting supplements or protein supplements or health drinks during the course of the study.
- Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.
Who cannot join
- Subjects who are resistance trained or undergoing resistance training.
- Subjects with blood pressure more than or equal to 140/90 mmHg, fasting plasma glucose more than 125 mg/dL and abnormal ECG.
- Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- Evidence or history of musculoskeletal, respiratory, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
- Subjects diagnosed with sleep apnea or related disorders.
- Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
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- History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- Subjects consuming alcohol (more than 3 standard drinks per week) or smokers ( more than 3 cigarettes per day).
- Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
- Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
- Subjects using any centrally acting anorectic agents, drugs that inhibit the absorption of nutrients and endocannabinoid neuromodulators during the two weeks prior to enrolment into the study.
- Subjects who underwent major surgical procedures in last 6 months.
- Subject with HIV positive or history of any other STDs.
- Subject has participated in a clinical study within the last 30 days prior to recruitment or concurrently participating in another study
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled Parallel Arm Clinical Study to Evaluate the Efficacy of LN18178 in Improving Muscle Strength, Aerobic Capacity and Body Composition in Healthy Young Males
The Purpose of the study is to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males.
Read the detailed description
A total of 120 male subjects aged between 36 and 50 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178:400 mg or Placebo at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 12 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
- Being tested
- LN18178, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LN18178Dietary supplement
400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks
PlaceboDietary supplement
One capsule to be consumed in the morning after breakfast with water for 12 Weeks
| Study group | Role | What they receive |
|---|---|---|
| LN18178 | Experimental | 400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks Receives: Dietary Supplement: LN18178 |
| Placebo | Other | One capsule to be consumed in the morning after breakfast with water for 12 Weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle strength (1-RM leg press)
It's the maximum amount of weight a subject can lift for one repetition of leg press. As the weight lifted increases, muscle strength also rises
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Secondary outcomes (11)
Change in Muscle strength ( 1-RM bench press)
It's the maximum amount of weight a subject can lift for one repetition of bench press. As the weight lifted increases, so does muscle strength.
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Muscle endurance (Repetitions to failure for leg press and bench press using 80% 1RM)
It refers to the maximum number of repetitions a person can perform at 80% of their one-repetition maximum (1RM) weight on the leg press and bench press. An increase in repetitions reflects improved muscle endurance.
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in training volume/capacity
It is a calculated value obtained by multiplying the number of sets, the number of repetitions per set, and the weight lifted in kilograms for an exercise. As training volume increases, so does muscle strength.
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in VO2 max testing (graded exercise test while O2 consumption measured)
The maximum amount of oxygen the body utilizes during graded exercise on an ergometer is measured as VO₂ max. An increase in VO2 max indicates improved cardiovascular fitness
Measured: Week 0 and Week 12
Change in Lean body mass (DEXA)
A low-dose X-ray (DEXA) is used to measure a person's lean mass. An increase in lean mass signifies notable improvements in muscle development.
Measured: Week 0 and Week 12
Change in Rate of Perceived Exertion (RPE) using 6-20 point Borg scale for exercise intensity
It is a measure of how much exertion a person feels at the end of an exercise session. A decrease in ratings on the Borg scale indicates reduced perceived exertion, reflecting improvements in muscle strength and endurance.
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in subjective rating of Energy, Fatigue, Focus and Confidence using VAS
The Visual Analogue Scale (VAS) is a 100 mm line, with zero representing the minimum score and 100 representing the maximum. Higher ratings on the scale correspond to increased levels of energy, reduced fatigue, and greater focus and confidence
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in subjective feeling of mental acuity, concentration, calmness and quality of sleep using VAS
The Visual Analogue Scale (VAS) is a 100 mm line, where zero represents the minimum score and 100 the maximum. Higher ratings on the scale indicate greater mental acuity, improved concentration, increased calmness, and better quality of sleep."
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Physical Activity Enjoyment Scale-8 (PACES)
The Physical Activity Enjoyment Scale-8 uses a 7-point bipolar rating scale to assess how a person currently feels about the physical activity they have been performing. Higher total scores indicate greater enjoyment of the activity.
Measured: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Serum biomarkers (IGF-1 - Insulin-like growth factor-1)
Insulin-like Growth Factor 1 (IGF-1) is a hormone that plays a key role in promoting muscle growth in adults. As serum IGF-1 levels increase, there is a corresponding rise in lean muscle mass
Measured: Week 0 and Week 12
Change in Serum biomarkers Myostatin
Myostatin is a myokine produced by muscle cells that serves as a negative regulator of muscle growth. Higher serum myostatin levels are associated with reduced lean mass and decreased muscle strength.
Measured: Week 0 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start4 Aug 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Muscle Strength RecoveryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GENCOR Lifestage Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092722
- Sponsor's protocol ID
- GNC/MS/LN18178/25
- Other IDs
- CTRI/2025/07/091371
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pandit SL, Yaligar D, Halemane M, Bhat A. A proprietary blend of standardized Punica granatum fruit rind and Theobroma cocoa seed extracts mitigates aging males' symptoms: A randomized, double-blind, placebo-controlled study. Int J Med Sci. 2022 Jul 11;19(8):1290-1299. doi: 10.7150/ijms.73645. eCollection 2022.
PubMed 35928723Sreeramaneni PGA, Yalamanchi A, Konda MR, Cherukuri SHV, Maroon JC. A Proprietary Herbal Blend Containing Extracts of Punica granatum Fruit Rind and Theobroma cocoa Seeds Increases Serum Testosterone Level in Healthy Young Males: A Randomized, Double-Blind Placebo-Controlled Study. J Diet Suppl. 2023;20(3):411-427. doi: 10.1080/19390211.2022.2035037. Epub 2022 Feb 6.
PubMed 35129040Rawson ES, Volek JS. Effects of creatine supplementation and resistance training on muscle strength and weightlifting performance. J Strength Cond Res. 2003 Nov;17(4):822-31. doi: 10.1519/1533-4287(2003)0172.0.co;2.
PubMed 14636102Garcia-Hermoso A, Sanchez-Lopez M, Martinez-Vizcaino V. Effects of Aerobic Plus Resistance Exercise on Body Composition Related Variables in Pediatric Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pediatr Exerc Sci. 2015 Nov;27(4):431-40. doi: 10.1123/pes.2014-0132. Epub 2015 Apr 22.
PubMed 25902557Ramos-Campo DJ, Andreu Caravaca L, Martinez-Rodriguez A, Rubio-Arias JA. Effects of Resistance Circuit-Based Training on Body Composition, Strength and Cardiorespiratory Fitness: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Apr 28;10(5):377. doi: 10.3390/biology10050377.
PubMed 33924785Holloszy JO. The biology of aging. Mayo Clin Proc. 2000 Jan;75 Suppl:S3-8; discussion S8-9.
PubMed 10959208Suchomel TJ, Nimphius S, Stone MH. The Importance of Muscular Strength in Athletic Performance. Sports Med. 2016 Oct;46(10):1419-49. doi: 10.1007/s40279-016-0486-0.
PubMed 26838985Kell RT, Bell G, Quinney A. Musculoskeletal fitness, health outcomes and quality of life. Sports Med. 2001;31(12):863-73. doi: 10.2165/00007256-200131120-00003.
PubMed 11665913
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled Parallel Arm Clinical Study to Evaluate the Efficacy of LN18178 in Improving Muscle Strength, Aerobic Capacity and Body Composition in Healthy Young Males
- ClinicalTrials.gov ID
- NCT07092722
- Acronym / sponsor ID
- GNC/MS/LN18178/25
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- GENCOR Lifestage SolutionsUniversity, hospital or other
- Study start
- 4 Aug 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 30 Jul 2025 (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 Purpose of the study is to evaluate the efficacy of LN18178 in improving muscle strength, aerobic capacity and body composition in healthy young males.
Detailed description
A total of 120 male subjects aged between 36 and 50 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either LN18178:400 mg or Placebo at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water for 12 weeks. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability. The safety assessment of the LN18178 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LN18178 | Experimental | Dietary Supplement: LN18178400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks |
| Placebo | Other | Dietary Supplement: PlaceboOne capsule to be consumed in the morning after breakfast with water for 12 Weeks |
Who may qualify
- Ages
- 36 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Untrained healthy male subjects aged between 36 and 50 years with a Body Mass Index (BMI) between 22 and 27 kg/m2.
- Willingness to do exercise training program during the course of the study.
- Subject considered generally healthy as per health history and routine clinical investigations.
- Ability to understand the risks and benefits of the protocol.
- Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
Key exclusion criteria (15 listed)
- Subjects who are resistance trained or undergoing resistance training.
- Subjects with blood pressure more than or equal to 140/90 mmHg, fasting plasma glucose more than 125 mg/dL and abnormal ECG.
- Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- Evidence or history of musculoskeletal, respiratory, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
- Subjects diagnosed with sleep apnea or related disorders.
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 |
|---|---|---|
| LN18178400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks | Dietary supplement | LN18178 |
| PlaceboOne capsule to be consumed in the morning after breakfast with water for 12 Weeks | Dietary supplement | Placebo |
Primary outcome
Change in Muscle strength (1-RM leg press)
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
It's the maximum amount of weight a subject can lift for one repetition of leg press. As the weight lifted increases, muscle strength also rises
11 secondary outcomes
Change in Muscle strength ( 1-RM bench press)
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Muscle endurance (Repetitions to failure for leg press and bench press using 80% 1RM)
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in training volume/capacity
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in VO2 max testing (graded exercise test while O2 consumption measured)
Time frame: Week 0 and Week 12
Change in Lean body mass (DEXA)
Time frame: Week 0 and Week 12
Change in Rate of Perceived Exertion (RPE) using 6-20 point Borg scale for exercise intensity
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in subjective rating of Energy, Fatigue, Focus and Confidence using VAS
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in subjective feeling of mental acuity, concentration, calmness and quality of sleep using VAS
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Physical Activity Enjoyment Scale-8 (PACES)
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
Change in Serum biomarkers (IGF-1 - Insulin-like growth factor-1)
Time frame: Week 0 and Week 12
Change in Serum biomarkers Myostatin
Time frame: Week 0 and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 35928723Pandit SL, Yaligar D, Halemane M, Bhat A. A proprietary blend of standardized Punica granatum fruit rind and Theobroma cocoa seed extracts mitigates aging males' symptoms: A randomized, double-blind, placebo-controlled study. Int J Med Sci. 2022 Jul 11;19(8):1290-1299. doi: 10.7150/ijms.73645. eCollection 2022.
- Background: PubMed 35129040Sreeramaneni PGA, Yalamanchi A, Konda MR, Cherukuri SHV, Maroon JC. A Proprietary Herbal Blend Containing Extracts of Punica granatum Fruit Rind and Theobroma cocoa Seeds Increases Serum Testosterone Level in Healthy Young Males: A Randomized, Double-Blind Placebo-Controlled Study. J Diet Suppl. 2023;20(3):411-427. doi: 10.1080/19390211.2022.2035037. Epub 2022 Feb 6.
- Background: PubMed 14636102Rawson ES, Volek JS. Effects of creatine supplementation and resistance training on muscle strength and weightlifting performance. J Strength Cond Res. 2003 Nov;17(4):822-31. doi: 10.1519/1533-4287(2003)0172.0.co;2.
- Background: PubMed 25902557Garcia-Hermoso A, Sanchez-Lopez M, Martinez-Vizcaino V. Effects of Aerobic Plus Resistance Exercise on Body Composition Related Variables in Pediatric Obesity: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pediatr Exerc Sci. 2015 Nov;27(4):431-40. doi: 10.1123/pes.2014-0132. Epub 2015 Apr 22.
- Background: PubMed 33924785Ramos-Campo DJ, Andreu Caravaca L, Martinez-Rodriguez A, Rubio-Arias JA. Effects of Resistance Circuit-Based Training on Body Composition, Strength and Cardiorespiratory Fitness: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Apr 28;10(5):377. doi: 10.3390/biology10050377.
- Background: PubMed 10959208Holloszy JO. The biology of aging. Mayo Clin Proc. 2000 Jan;75 Suppl:S3-8; discussion S8-9.
- Background: PubMed 26838985Suchomel TJ, Nimphius S, Stone MH. The Importance of Muscular Strength in Athletic Performance. Sports Med. 2016 Oct;46(10):1419-49. doi: 10.1007/s40279-016-0486-0.
- Background: PubMed 11665913Kell RT, Bell G, Quinney A. Musculoskeletal fitness, health outcomes and quality of life. Sports Med. 2001;31(12):863-73. doi: 10.2165/00007256-200131120-00003.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing LN18178 in people with Muscle Strength Recovery and Endurance, run by GENCOR Lifestage Solutions.
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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mr Machiraju Garga (+91 8331015019, machiraju.gls@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle strength (1-RM leg press) (time frame: Week 0, Week 2, Week 4, Week 8 and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092722, which also lists 8 linked publications.
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 Jul 2025.