Sarcopenia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTwhey protein isolate
Take 1 sachet/day for 12 weeks.
DIETARY_SUPPLEMENTisolated soy protein
Take 1 sachet/day for 12 weeks.
DIETARY_SUPPLEMENTplacebo
Take 1 sachet/day for 12 weeks.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 12 weeks | Using handgrip strength instrument (high value means high strength) |
| Muscle mass | 12 weeks | Using Bioelectrical Impedance Analysis instrument (high value means high mass) |
| Physical performance | 12 weeks | Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance. |
| Sarcopenia score | 12 weeks | Sarcopenia questionnaires (score 1 to 10 means low severity to high severity) |
| Body weight | 12 weeks | Body weight of the patients |
| Body mass index | 12 weeks | Body mass index of the patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of immunoglobulin in serum | 12 weeks | Measure concentration of immunoglobulin in serum |
| Concentration of glucose in serum | 12 weeks | Measure concentration of glucose in serum |
| 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 sodium in serum | 12 weeks | Measure concentration of sodium in serum |
| Concentration of aspartate transaminase in serum | 12 weeks | Measure concentration of aspartate transaminase in serum |
| Concentration of alanine aminotransferase in serum | 12 weeks | Measure concentration of alanine aminotransferase in serum |
| Concentration of alkaline phosphatase in serum | 12 weeks | Measure concentration of alkaline phosphatase in serum |
| Skin reaction | 12 weeks | Found or not found |
| Respiratory reaction | 12 weeks | Found or not found |
| Gastrointestinal tract reaction | 12 weeks | Found or not found |
| Concentration of creatinine in serum | 12 weeks | Measure concentration of creatinine in serum |
| Concentration of blood urea nitrogen in serum | 12 weeks | Measure concentration of blood urea nitrogen 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) |
| 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 total protein in serum | 12 weeks | Measure concentration of total protein in serum |
Outcome results
None listed