Sarcopenia
Conditions
Brief summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.
Detailed description
A previous study has indicated that Ishige Okamurae extracts may increase muscle mass and strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 300 mg of Ishige Okamurae extracts or a placebo each day for 12 weeks.
Interventions
DIETARY_SUPPLEMENTIshige Okamurae extracts group
Ishige Okamurae extracts 300 mg/day for 12 weeks
DIETARY_SUPPLEMENTPlacebo group
Placebo 300 mg/day for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* \<110% of the standard lean body mass as measured using the body composition analyzer * Body mass index (BMI) ranging from 18.5 to 30.0 kg/m2 * Those who have an average protein intake of 60 g or more/day.
Exclusion criteria
* Abnormal liver or renal function (more than twice the normal upper limit of the research institute) * Uncontrolled diabetes mellitus (\>160 mg/dL of fasting blood sugar) * History of fracture during the previous year * Uncontrolled hypertension (\>160/100 mmHg) * Uncontrolled thyroid diseases. * History of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months * History of any central bone fracture within 1 year * History of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. * Alcohol abuser * Allergic reaction to Ishige Okamurae * Those who participated in other drug clinical trials within 1 month from the screening date. * Severe gastrointestinal symptoms such as heartburn and indigestion * Those who are pregnant, lactating, or plan to become pregnant during the clinical trial * Those who are judged to be unsuitable by the PI for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle strength | 12 weeks | the peak torque at 60°/s knee extension (/kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| appendicular skeletal mass/weight x 100 | 12 weeks | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| skeletal Muscle Mass Index/(height x height) | 12 weeks | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| appendicular skeletal mass/(height x height) | 12 weeks | using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks |
| concentration of lactate (mg/dL) | 12 weeks | lactate (IU/L) measured at baseline and after 12 weeks |
| EuroQol five dimensional three levels | 12 weeks | an index of life quality, minimum, maximum values (-0.171, 1), higher scores mean a better outcome, which will be measured at baseline and after 12 weeks |
| concentration of creatinine kinase (IU/L) | 12 weeks | creatinine kinase (IU/L) measured at baseline and after 12 weeks |
Countries
South Korea
Outcome results
None listed