None listed
Conditions
Interventions
Intervention1: Meet Shilajeet 500 mg- capsule- 2 times per day: Shilajit Extract (60% Fulvic acid)- 500 Mg
Control Intervention1: Microcrystalline Cellulose Capsules - Placebo - 500 mg 2 times per day
Sponsors
Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy male and female adult participants aged 30 to 55 years at the time of screening. 2) Participants with a body mass index (BMI) of 18.5- 30 kg/m2. 3) Clinically healthy as determined by medical history, physical examination and vital signs (within the normal limits). 4) Moderately active individuals (e.g., engaging in light-to-moderate physical activity 2-4 times per week). 5) Willing to maintain habitual diet and physical activity levels throughout the study duration. 6) Able to perform the assessment tests (Dynamometer- based tests and VO2 max testing). 7) No history of recent musculoskeletal injury (within past 3 months) that could affect performance of the assessment tests. 8) Intact, healthy skin at assessment sites (no active dermatological conditions, wounds, or infections). 9) Willing to avoid application of topical products on test areas prior to assessments (as per protocol). 10) Willing to avoid use of nutritional supplements, herbal products (including Shilajeet), or performance enhancing products during the study. 11) Not currently on medications that may affect muscle metabolism, immune function or nutrient absorption. 12) Participants must be willing to abstain from excessive alcohol consumption throughout the study period and from any alcohol intake for at least 24-48 hours prior to each study assessment. 13) Willingness and ability to comply with study procedures and visit schedules. 14) Participants willing to provide written informed consent prior to initiation of any study-related procedures 15) Participants should be available for duration of study period (12 weeks).
Exclusion criteria
Exclusion criteria: 1) Individuals currently undertaking resistance training exercise or intense athletic training. 2) History of clinically significant medical conditions, including but not limited to cardiovascular,neurological, psychiatric, renal, immunological, endocrine, metabolic (such as uncontrolled diabetes or thyroid disease), gastrointestinal conditions (malabsorption syndromes, chronic diarrhoea, inflammatory bowel disease) or haematological disorders. 3) History of autoimmune or immunodeficiency disorders. 4) History of rhabdomyolysis or persistently elevated creatine kinase (CK). 5) Any condition that may affect muscle metabolism, immune function or nutrient absorption. 6) Use of medications known to affect muscle metabolism, immune function, or nutrient absorption within 4 weeks prior to screening, including corticosteroids, statins, immunosuppressants or biologics, proton pump inhibitors (chronic use) or chronic laxatives or any other drugs that may influence the study outcome. 7) History of musculoskeletal injury, surgery, or chronic pain or any condition affecting mobility or strength within the past 3 months that would interfere with assessment. 8) Consumed any dietary supplements or herbal drugs within 7 days prior to screening. 9) Use of medications, supplements or topical creams (retinol, anti-aging cream, etc) that may interfere with study outcomes, as determined by the Investigator. 10) Use of nutritional supplements, herbal products (including Shilajeet), protein supplements, or performance-enhancing substances within 4 weeks prior to screening 11) Known hypersensitivity to herbal drugs, nutritional supplements, or foods. 12) Participants with any history of current alcohol or substance abuse or current heavy tobacco use, typically greater than equal to 20 cigarettes per day. 13) Clinically significant abnormal laboratory values deemed relevant by the Investigator. 14) Participation in another clinical trial within 30 days prior to screening. 15) Any condition which, in the Investigator s opinion, may compromise participant safety or interfere with study compliance or data interpretation. 16) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Meet Shilajeet Supplement in improving muscle strength and recovery in healthy adults, compared to placebo. 2) To evaluate protein utilization by assessing changes in lean body mass (fat-free mass) and skeletal muscle mass in healthy adults, compared to placebo.Timepoint: Baseline, Week 6 and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To evaluate the effect of the Meet Shilajeet supplement on aerobic endurance in healthy adults, compared to placebo. 2) To assess improvement in skin health including elasticity, hydration, and barrier integrity. 3) To assess the effect of Meet Shilajeet supplementation on micronutrient status in healthy adults, compared to placebo. 4) To assess the effect of Meet Shilajeet supplementation on immune cell profile compared to placebo. 5) To assess the safety and tolerability of Meet Shilajeet supplement.Timepoint: Baseline, Week 6 and Week 12 | — |
Countries
India
Contacts
Public ContactMeena Dalal
TrialGuna Private Limited
Outcome results
None listed