None listed
Conditions
Interventions
Intervention1: CL19183 450mg: One capsule daily in the morning after breakfast with water
Control Intervention1: Placebo: One capsule daily in the morning after breakfast with water
Sponsors
CLS Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 55-85 years (5 years post menopause in women and men greater than 65 yrs. of age) with a Body Mass Index (BMI) of between 22 and 29.9 kg/m2. 2. Subjects with hand-grip strength will be greater than 28 kg for men and greater than 18 kg for women; (AWGS, 2019). 3. Subjects who score above 9 in the SPPB (Short Physical Performance Battery) tests. 4. Subjects agreed to get assessed for physical activity using (Global Physical Activity Questionnaire) GPAQ. 5. Subjects willing to participate in warming up followed by brisk walking exercise (5 days a week, 30 min per day) over study duration. 6. Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator. 7. Subject willing to provide written informed consent and agree to be available for regular follow up throughout the study duration. 8. Subjects who are not nutritionally deprived or malnourished assessed using MNA-SF. 9. Willing to keep dietary records to allow macronutrient intake to be calculated during the study period.
Exclusion criteria
Exclusion criteria: 1. Subjects having allergy or hypersensitivity to any of the ingredients in the investigational products. 2. Subjects with any pre-existing medical conditions which in the opinion of the investigator makes the subject unsuitable for inclusion. 3. Subjects underwent treatment for COVID-19 or tested positive during the study will be excluded. 4. Subjects who are receiving treatment for serious diseases (e.g., cardiovascular, immunological, respiratory, hepatobiliary, renal, neurological, musculoskeletal, mental, and infectious diseases, or malignant tumor). 5. Subjects with TSH levels lesser than or equal to 0.1 IU/mL or greater than or equal to 10 IU/mL, Creatinine levels greater than 2 mg/dl and AST or ALT levels 3X higher than the normal standard. 6. Serious musculoskeletal abnormalities or damage to the lower extremities. 7. History of cancer within 5 years or are currently being treated (except for skin tumors other than melanoma). 8. Use of functional food or supplement for muscle strength improvement within prior two weeks. 9. Subjects who participated in resistance exercise within three months prior to the first/screening visit. 10. Subjects who participated in other interventional clinical trial in past three months. 11. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 12. Any surgery or fracture in lower limb in past 6 months or any impairment or disease severely affecting gait (e.g. Parkinsons disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management). 13. Subjects with diabetes (FBS greater than or equal to 126 mg/dL), hypertension (Systolic greater than 140 and Diastolic greater than 90 mmHg). 14. Subjects with COPD, asthma, any respiratory or breathing related disorders. 15. Subjects consuming excessive amounts of alcohol (more than 5 drinks per week) and smoking more than 5 cigarettes per day within three months. 16. Subjects using any dietary supplements that could interfere with the study outcomes, including protein, amino acids, leucine, beta-alanine, HMB, creatine or other supplements known to impact muscle. 17. Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc. 18. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids. 19. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks prior to screening. 20. Subjects with HIV positive or any other STDs. 21. Subjects who are inappropriate per investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study in Quadriceps strength using (1RM) using leg extension exerciseTimepoint: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in body fat mass (%), (kg) through DEXATimepoint: Week 0 (Baseline), Week 8 and Week 16.;Change in Body fat ratio (muscle/fat) measured by DEXATimepoint: Week 0 (Baseline), Week 8 and Week 16.;Change in Grip strength (Using digital hand dynamometer)Timepoint: Screening visit, Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.;Six minute walk test (V2 to V7)Timepoint: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.;Degree of change in SMI (ASM/ height2) using DEXATimepoint: Week 0 (Baseline), Week 8 and Week 16.;Change in Skeletal muscle mass (SMM) using an appropriate method measured by DEXATimepoint: Week 0 (Baseline), Week 8 and Week 16.;Change in ASM/weight x 100Timepoint: Week 0 (Baseline), Week 8 and Week 16.;Change in Quality of Life Questionnaire (EQ- 5D- 3L)Timepoint: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.;Change in Fasting InsulinTimepoint: Week 0 (Baseline) and Week 16.;Change in Hs-CRP concentration and Sarcopenia Index (based on Serum creatinine& Serum Cystatin C)Timepoint: Week 0 (Baseline) and Week 16.;Change in Antioxidant Index: MDATimepoint: Week 0 (Baseline) and Week 16.;Change in Antioxidant enzyme activity (GPX, GSH, SOD, CAT)Timepoint: Week 0 (Baseline) and Week 16.;Change in Isokinetic exercise to confirm quadriceps and hamstrings strength using EasyforceTimepoint: Week 0 (Baseline) and Week 16.;Change in Timed up and go, TUGTimepoint: Week 0 (Baseline) and Week 16.;Change in Inflammatory cytokine (TNF-alpha, IL-1, IL-6) production level.Timepoint: Week 0 (Baseline) and Week 16. | — |
Countries
India
Contacts
Public ContactMr Ajjarapu Srinivasu
CLS Pvt. Ltd.
Outcome results
None listed