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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
120
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
Time frame: Week 0, Week 2, Week 4, Week 8 and Week 12
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.
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)
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.
Time frame: 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.
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)
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
Time frame: 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.
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Time frame: 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.
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
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
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
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."
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Week 0 and Week 12