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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-04

Study Completion Date

2026-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Creatine Supplementation in Young Healthy Adults

NCT06604793

Improve Muscle Performance in Young Adults

RECRUITING NA

Investigation of the Efficacy and Safety of Three Test Products and Comparator on Muscular Performance After the Initiation of a Resistance Training Program

NCT04814225

Muscle Strength

COMPLETED PHASE2

Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men

NCT06061315

Body Composition Lean Body Mass Muscle Strength +1 more

COMPLETED NA

Manipulation of Dietary Protein and the Anabolic Response

NCT01820975

Focus: Anabolic Response to Food Intake in Young Individuals Condition Relevance: Skeletal Muscle Health, Sarcopenia

COMPLETED NA

Effect of 12-week Milk Fat Globule Membrane Supplementation on the Human Muscle Function of Healthy, Recreationally Active Adults

NCT06573749

Ageing Well Neuromuscular Function

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Strength Recovery Endurance Healthy Human Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LN18178

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

Group Type EXPERIMENTAL

LN18178

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type OTHER

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LN18178

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Untrained healthy male subjects aged between 36 and 50 years with a Body Mass Index (BMI) between 22 and 27 kg/m2.
2. Willingness to do exercise training program during the course of the study.
3. Subject considered generally healthy as per health history and routine clinical investigations.
4. Ability to understand the risks and benefits of the protocol.
5. Subject should provide written informed consent and agree to be available for regular follow up throughout the study duration.
6. Subjects who are sexually active must agree to use adequate non-hormonal contraception during the study
7. Subjects agree to maintain current diet and activity level.
8. Subject agrees not to start any new therapies for energy boosting supplements or protein supplements or health drinks during the course of the study.
9. Subjects willing to refrain from drinking coffee or caffeinated drinks or beverages during the study.

Exclusion Criteria

1. Subjects who are resistance trained or undergoing resistance training.
2. Subjects with blood pressure more than or equal to 140/90 mmHg, fasting plasma glucose more than 125 mg/dL and abnormal ECG.
3. Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
4. Evidence or history of musculoskeletal, respiratory, haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies.
5. Subjects diagnosed with sleep apnea or related disorders.
6. Subjects consuming medications that can interfere with muscle mass such as corticosteroids, testosterone replacement or anabolic drugs.
7. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
8. Subjects consuming alcohol (more than 3 standard drinks per week) or smokers ( more than 3 cigarettes per day).
9. Subjects who consume recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or chewable tobacco products.
10. Subjects under medications including anti-hypertensives, antidepressants, anticholinergics, inhaled beta agonists, anti-hyperlipidemics, psychotropics etc.
11. 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.
12. Subjects who underwent major surgical procedures in last 6 months.
13. Subject with HIV positive or history of any other STDs.
14. Subject has participated in a clinical study within the last 30 days prior to recruitment or concurrently participating in another study

\-

Minimum Eligible Age

36 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes