Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

Chulalongkorn University

Status: Not yet enrolling

Conditions: Sarcopenia

Treatments: Dietary Supplement: isolated soy protein; Dietary Supplement: whey protein isolate; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05869305

IRBRTA 426/2566

Details and patient eligibility

About

The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.

Full description

There are 45 patients in this study. They are randomly divided into 3 groups which are whey protein isolate group, isolated soy protein group, placebo group. They will take the sample 1 sachet/day for 12 weeks. Muscle strength, muscle mass, physical performance, sarcopenia score, body weight, body mass index, protein, immunoglobulins, quality of life, liver function, kidney function, other laboratory value, and adverse effects are evaluated.

Enrollment: 45 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 20 years
• Sarcopenia score more than 4
• Handgrip strength less than 28 kg in male and less than 18 kg in female and muscle mass less than 7 kg/m2 in male and less than 5.7 kg/m2 in female or Gait speed (6-meter walk) less than 1 m/s
• Can take protein from animal
• Can read and write or have people to look after
• Willing to participate in this study

Exclusion criteria

• Allergic to protein from animals and plants
• Hepatitis or cirrhosis
• Glomerular disease or glomerular filtration rate less than 60 ml/min/1.73m2
• Cancer or heart disease
• Cannot walk
• Pregnancy and lactation
• Duodenal surgery
• Take protein supplement within 2 weeks
• Take protein in normal food more than 1.2 g/body weight/day
• Participating in other studies

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

whey protein isolate group

Experimental group

Description:

Whey protein isolate is contained in the sachet.

Treatment:

Dietary Supplement: whey protein isolate

isolated soy protein group

Experimental group

Description:

Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.

Treatment:

Dietary Supplement: isolated soy protein

placebo group

Experimental group

Description:

Base powder without proteins is contained in the sachet

Treatment:

Dietary Supplement: placebo