None listed
Conditions
Interventions
Intervention1: SG Gold: Dosage form: Capsules
Dose: 1 cap/day 30-45 minutes before exercise
Duration:60days
Cohort A - With protein
Cohort B - Without protein
Intervention2: SG alone: Dosage form:
Sponsors
KAPIVA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male volunteers between the age group of 25-45 years. 2. Subjects who are familiar with weight training and had atleast 4 months of experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours per week). 3. Subjects who are willing and able to understand and follow the protocol and provide informed consent. 4. Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications during the course of this study. 5. Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range
Exclusion criteria
Exclusion criteria: 1. Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological) 2. Patients with pre-existing severe systemic disease necessitating long-term medication. 3. Subjects suffering from any serious medical or surgical illness. 4. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ. 5. Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments. 6. Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry. 7. More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks. 8. Use of Astemizole, Nedocromil, Cromolyn, long acting ß agonists, Ketotifen, Theophylline or testosterone within 4 weeks before. 9. Participation in the current or previous clinical trial with any approved investigational products during the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The change from baseline testosterone assessed by free and total testosterone. 2.The improvement in Cortisol cycle from baseline is assessed by evaluating Cortisol value. 3.Improvement in protein absorption from screening Visit 0 to Day 1 and Day 3 and all other consecutive visits. 4.The change from baseline muscle and connective tissue strength, assessed by one-repetition maximum (1-RM) bench and leg presses, and handgrip strength (Dynamometer), cable pull-down repetitions, time to exhaustion on a treadmill, mid-upper arm circumference (MUAC). Timepoint: Day 0 Day 15 Day 30 Day 45 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in muscle recovery measured through Biomarkers (LDH (Serum lactate de hydrogenase), CK (Creatine Kinase), BUN) on Day 0, 30 and 60. 2. Improvement in muscle mass and strength evaluated by Troponin T (Day 0, 30, 60). 3. Modulation of inflammatory biomarkers (Day 0, 30, 60). 4. Improvement in endurance based on Serum Ferritin levels and Serum lactate (Day 0,30, 60). 5. Improvement in serum anti-oxidant level (Day 0,30,60). 6. Reduction in muscle fatigue during heavy workout evaluated by measurement of Serum hydroxyproline levels (Day 0,30,60). 7. Reduction in muscle soreness assessed by VAS Pain score. 8. Reduction in fat and better fat distribution and improved muscle mass (through Lipid profile and BMI determination)Timepoint: Day 0 Day 30 and Day 60;9. Improvement in joint health and recovery, stamina and sustained energy level and the safety of SG product and consumer acceptance through Self-Assessment and Feedback questionnaires through Global Physical Activity QuestionnairesTimepoint: Day 0 Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactDrBalu Kolar
KAPIVA
Outcome results
None listed