The ability of essential amino acids to boost muscle mass in people who suffer from muscle loss.

Phase 3

Recruiting

• Conditions: Muscle wasting and atrophy, not elsewhere classified,

• Registration Number: CTRI/2024/02/063107
• Lead Sponsor: pimary investigator

Brief Summary

This is a prospective, randomised placebo-controlled trial, double-blinded with a convenience sampling of the patients visiting our department in Sher-e-Kashmir Institute of Medical Sciences, Srinagar who are in the age group of 50 to 90 years (sample size of 50; 25 in each group (intervention arm and control arm)) comparing the efficacy of essential amino acid sticks (4gm of EAA sticks containing L Lysine 378mg, L Leucine 342 mg, L Arginine 315 mg, Valine 302mg, L Methionine 302mg, Iso Leucine 302 mg, L Phenylalanine 203 mg, L Threonine 203 mg, L Histidine 158mg, L Tryptophan 104 mg, Vitamin D3 600 IU BD for 4 weeks) and in the control arm (4gm of placebo stick containing Maltodextrin, Malic Acid,Guava Powder Flavour, Citric acid anhydrous, Acusulfame potassium, Beet root Powder, Collodial Sillicon Dioxide, Magnesium Sterate BD for 4 weeks) on individuals who fall below the cutoff Ishii sarcopenia score. The primary outcome measures will be the Ishii score and Isometric Quadriceps muscle strength on the DAVID machine at 0, 4 and 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Last Update Posted: 2024-04-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Healthy individuals 50 years and above age who fall below the cutoff Ishii sarcopenia score.

Exclusion Criteria

severe cognitive impairment, poor controlled psychiatric disease, acute infections or known cancer, rheumatoid arthritis, osteonecrosis of the knee, post-traumatic OA, severe hepatic or renal disease, or other condition which could affect the metabolism of nutrients such as cancer, diabetes mellitus and obesity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ishii Score	0, 4 and 12 weeks
Muscle strength on DAVID	0, 4 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Deterioration of muscle strength	6 months

Trial Locations

Locations (1)

Sher-i-Kashmir Institute of Medical Sciences; 🇮🇳 JAMMU, & KASHMIR, India

Sher-i-Kashmir Institute of Medical Sciences

🇮🇳JAMMU, & KASHMIR, India

Dr Tufail Muzaffar

Principal investigator

9419418912

tufailmuzaffar@gmail.com