Efficacy of LN18178 in Improving Muscle Strength, Aerobic Capacity and Body Composition in Healthy Young Males

NCT07092722 | Not Yet Recruiting

• 2 other identifiers: GNC/MS/LN18178/25CTRI/2025/07/091371
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Muscle Strength Recovery; Endurance; Healthy Human Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Change in Muscle strength ( 1-RM bench press)

  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)

  Week 0, Week 2, Week 4, Week 8 and Week 12

• Change in training volume/capacity

  Week 0, Week 2, Week 4, Week 8 and Week 12

• Change in VO2 max testing (graded exercise test while O2 consumption measured)

  Week 0 and Week 12

• Change in Lean body mass (DEXA)

  Week 0 and Week 12

Study Arms (2)

LN18178

EXPERIMENTAL

400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks

Dietary Supplement: LN18178

Placebo

OTHER

One capsule to be consumed in the morning after breakfast with water for 12 Weeks

Dietary Supplement: Placebo

Interventions

LN18178 DIETARY_SUPPLEMENT

400 mg, One capsule to be consumed in the morning after breakfast with water for 12 Weeks

LN18178

Placebo DIETARY_SUPPLEMENT

One capsule to be consumed in the morning after breakfast with water for 12 Weeks

Placebo

Eligibility Criteria

• Age: 36 Years - 50 Years
• Gender Eligibility Details: Untrained healthy male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GENCOR Lifestage Solutions: lead

Related Publications (8)

• 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.

  PMID: 35928723 BACKGROUND

• 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.

  PMID: 35129040 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.

  PMID: 14636102 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.

  PMID: 25902557 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.

  PMID: 33924785 BACKGROUND

• Holloszy JO. The biology of aging. Mayo Clin Proc. 2000 Jan;75 Suppl:S3-8; discussion S8-9.

  PMID: 10959208 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.

  PMID: 26838985 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.

  PMID: 11665913 BACKGROUND

Central Study Contacts

Mr Machiraju Garga

CONTACT

+91 8331015019; machiraju.gls@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: August 4, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share