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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2025/07/091371 | Registry Identifier | Clinical Trial Registry - India Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LN18178 | Experimental | 400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks |
|
| Placebo | Other | One capsule to be consumed in the morning after breakfast with water for 12 Weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LN18178 | Dietary Supplement | 400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 0, Week 2, Week 4, Week 8 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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
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Untrained healthy male subjects
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mr Machiraju Garga | Contact | +91 8331015019 | machiraju.gls@gmail.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35928723 | Background | 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. | |
| 35129040 | Background |
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| Placebo | Dietary Supplement | One capsule to be consumed in the morning after breakfast with water for 12 Weeks |
|
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. |
| 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. | 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 | 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. | 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. | 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 | 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." | 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. | 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 | 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. | Week 0 and Week 12 |
| Sreeramaneni 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. |
| 14636102 | Background | Rawson 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. |
| 25902557 | Background | Garcia-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. |
| 33924785 | Background | Ramos-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. |
| 10959208 | Background | Holloszy JO. The biology of aging. Mayo Clin Proc. 2000 Jan;75 Suppl:S3-8; discussion S8-9. |
| 26838985 | Background | Suchomel 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. |
| 11665913 | Background | Kell 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. |