Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
- Conditions
- Sarcopenia
- Interventions
- Dietary Supplement: whey protein isolateDietary Supplement: isolated soy proteinDietary Supplement: placebo
- Registration Number
- NCT05869305
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description whey protein isolate group whey protein isolate Whey protein isolate is contained in the sachet. isolated soy protein group isolated soy protein Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet. placebo group placebo Base powder without proteins is contained in the sachet
- Primary Outcome Measures
Name Time Method Muscle strength 12 weeks Using handgrip strength instrument (high value means high strength)
Physical performance 12 weeks Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
Body weight 12 weeks Body weight of the patients
Muscle mass 12 weeks Using Bioelectrical Impedance Analysis instrument (high value means high mass)
Sarcopenia score 12 weeks Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
Body mass index 12 weeks Body mass index of the patients
- Secondary Outcome Measures
Name Time Method Concentration of calcium in serum 12 weeks Measure concentration of calcium in serum
Concentration of magnesium in serum 12 weeks Measure concentration of magnesium in serum
Concentration of aspartate transaminase in serum 12 weeks Measure concentration of aspartate transaminase in serum
Concentration of immunoglobulin in serum 12 weeks Measure concentration of immunoglobulin in serum
Concentration of alkaline phosphatase in serum 12 weeks Measure concentration of alkaline phosphatase in serum
Respiratory reaction 12 weeks Found or not found
Concentration of glucose in serum 12 weeks Measure concentration of glucose in serum
Concentration of sodium in serum 12 weeks Measure concentration of sodium in serum
Concentration of blood urea nitrogen in serum 12 weeks Measure concentration of blood urea nitrogen in serum
Skin reaction 12 weeks Found or not found
Gastrointestinal tract reaction 12 weeks Found or not found
Hungry feeling 12 weeks Using visual analogue scale 0 to 10 (No hungry to very hungry)
Quality of life of the patient 12 weeks 36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome)
Concentration of creatinine in serum 12 weeks Measure concentration of creatinine in serum
Nutritional status 12 weeks 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)
Concentration of total protein in serum 12 weeks Measure concentration of total protein in serum
Concentration of alanine aminotransferase in serum 12 weeks Measure concentration of alanine aminotransferase in serum