A clinical study assessing how Sarcoboost improves physical strength, mobility, and quality of life in people with Sarcopenia and Type 2 Diabetes Mellitus.

A Randomized, Controlled Study to Evaluate the Effect of Sarcoboost Supplementation on Physical Performance, Strength and Quality of Life in Patients with Sarcopenia and Type 2 Diabetes Mellitus (T2DM). - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/098758

Enrollment

500

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M628- Other specified disorders of muscle Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: 5g Sarcoboost (3g CaHMB + 300mg Magnesium + 600 IU Vitamin D) + Resistance Training + Balanced Diet: Administered once daily for twelve weeks, with the option to extend usage for an add

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged between 40 and 70 years (both ages inclusive). 2. Diagnosed with Type 2 Diabetes Mellitus (T2DM) for more than 1 year, with no change in antidiabetic medication for at least the past 3 months. 3. Most recent HbA1c less than 8 percent 4. Diagnosed Sarcopenia (AWGS criteria and Indian consensus) 5. Subjects who are willing to comply with all protocol-specified requirements, including study visits, procedures, and follow-up assessments.

Exclusion criteria

Exclusion criteria: 1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug 2. Uncontrolled diabetes (HbA1c greater than 10 percent) 3. Patients with Any other co-morbid conditions barring physical activities which limit or preclude their ability to undergo study assessment 4. Severe renal impairment (Estimated GFR less than 30 millilitres per minute). 5. Active malignancy 6. Known allergy to any ingredient of supplements 7. Severe end organ damage 8. Participation in another trial within 3 months. 9. Severe cases of Sarcopenia 10. Patients on Testosterone therapy/ any other pharmacological therapy for Sarcopenia 11. Patients with Hypothyroidism

Design outcomes

Primary

Measure	Time frame
Assess the effect of Sarcoboost on physical performance (SPPB test) in Patients with Sarcopenia and Type 2 Diabetes Mellitus (T2DM).Timepoint: Baseline and Week 12	—

Secondary

Measure	Time frame
- Changes in Handgrip, - Changes in glycemic control (HbA1c, fasting glucose) - Changes in quality of life (SF-36) - Changes in SPPB - Incidence of adverse events Timepoint: Baseline, week 12 and week 24 ( if extended)	—

Countries

India

Contacts

Public ContactKalpana Sharma

Zyfis Lifesciences Private Limited

dimple.shah@zyfis.in09979724293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026