Effectiveness of plant-based protein powder recipes to muscle mass and health in elderly sarcopenia subjects

Phase 2

Recruiting

• Conditions: Sarcopenia patients (age above 60 year old); Plant-based protein powder, sarcopenia

• Registration Number: TCTR20231101005
• Lead Sponsor: ational Research Council of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study Completion: 2024-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

1.Elderly (age above 60) who have sarcopenia (The Asian Working Group for Sarcopenia (AWGS) 2019;
1.1.Handgrip strength less than 28 kg in male or less than 18 kg in female
1.2.Muscle mass measured by Bioelectrical impedence analysis (BIA) <7.0 kg/m2 in male or <5.7 kg/m2 in female
1.3.Calf circumference less than 34 cm in male or less than 33 cm in female
1.4.SARC-F (Strength, assistance with walking, rising from a chair, climbing stairs, and falls) >4

Exclusion Criteria

1.Abnormal vital sign (Temp > 37.5 , pulse > 100 beat/min, Blood pressure < 90/60 or > 160/90 mmHg at rest)
2.history of Diabetes Mellitus
3.Abnormal liver enzyme
4.Uncontrollable hyperlipidemia
5.Glomerular Filtration Rate; GFR less than 60%
6.Has nephrotic syndrome
7.Receive anticoagulant
8.History of cancer
9. Dementia patients
10. Heart disease or have pacemaker
11.Abnormality of blood chemistry
-Hemoglobin < 8 g/dL
-White blood cells < 4,000 per cu. mm.
-Platelets < 100,000 per cu. mm.
-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times the upper limit of normal
-Creatinine more than 1.8 times the upper limit of normal, and
-Abnormal urine analysis (protein positive in urine > 2+)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
muscle mass 0 and at the end of 3 months Dual energy X-ray adsorptiometry ,muscle mass at 0, 1 month, 2 months, 3 months and 6 months Bioelectrical impedance

Secondary Outcome Measures

Name	Time	Method
physical performance at 0, 1 month, 2 months, 3 months and 6 months 6-meters walk, 5-time chair stand test, time up and go test,calf circumference at 0, 1 month, 2 months, 3 months and 6 months measure calf circumference ,SARC-F (Strength, assistance with walking, rising from a chair, climbing stairs, and falls) at 0 and 3 months questionares,EQ-5D at 0 and 3 months questionares,Blood chemistry at 0 and 3 months Complete blood count, serum protein, albumin and globulin, glucose, calcium, magnesium, electrolyte,safety profile at 0, 1 month, 2 months, 3 months BUN, creatinine, liver enzyme (AST, ALT),Urine metabolome at 0, 1 month, 2 months, 3 months and 6 months mass spectrometer