Efficacy and Safety of Protein Product in Volunteers With Sarcopenia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: whey protein isolate; Dietary supplement: isolated soy protein; Dietary supplement: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whey protein isolate group; Whey protein isolate is contained in the sachet.	Dietary supplement: whey protein isolate; Take 1 sachet/day for 12 weeks.
Experimental: isolated soy protein group; Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.	Dietary supplement: isolated soy protein; Take 1 sachet/day for 12 weeks.
Experimental: placebo group; Base powder without proteins is contained in the sachet	Dietary supplement: placebo; Take 1 sachet/day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Using handgrip strength instrument (high value means high strength)	12 weeks
Muscle mass	Using Bioelectrical Impedance Analysis instrument (high value means high mass)	12 weeks
Physical performance	Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.	12 weeks
Sarcopenia score	Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)	12 weeks
Body weight	Body weight of the patients	12 weeks
Body mass index	Body mass index of the patients	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status	Nutritional score (score 0 to 17 means lack of nutrition, score 17 to 23.5 means risk to have lack of nutrition, score 24 to 30 means normal nutrition)	12 weeks
Hungry feeling	Using visual analogue scale 0 to 10 (No hungry to very hungry)	12 weeks
Skin reaction	Found or not found	12 weeks
Respiratory reaction	Found or not found	12 weeks
Gastrointestinal tract reaction	Found or not found	12 weeks
Quality of life of the patient	36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)	12 weeks
Concentration of total protein in serum	Measure concentration of total protein in serum	12 weeks
Concentration of immunoglobulin in serum	Measure concentration of immunoglobulin in serum	12 weeks
Concentration of glucose in serum	Measure concentration of glucose in serum	12 weeks
Concentration of calcium in serum	Measure concentration of calcium in serum	12 weeks
Concentration of magnesium in serum	Measure concentration of magnesium in serum	12 weeks
Concentration of sodium in serum	Measure concentration of sodium in serum	12 weeks
Concentration of creatinine in serum	Measure concentration of creatinine in serum	12 weeks
Concentration of blood urea nitrogen in serum	Measure concentration of blood urea nitrogen in serum	12 weeks
Concentration of aspartate transaminase in serum	Measure concentration of aspartate transaminase in serum	12 weeks
Concentration of alanine aminotransferase in serum	Measure concentration of alanine aminotransferase in serum	12 weeks
Concentration of alkaline phosphatase in serum	Measure concentration of alkaline phosphatase in serum	12 weeks

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): March 20, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: IRBRTA 426/2566

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No