Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia
- Conditions
- Sarcopenia
- Interventions
- Dietary Supplement: Ishige Okamurae extracts groupDietary Supplement: Placebo group
- Registration Number
- NCT04617951
- Lead Sponsor
- Pusan National University Yangsan Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- <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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ishige Okamurae extracts group Ishige Okamurae extracts group This group takes Ishige Okamurae extracts for 12 weeks. Placebo group Placebo group This group takes placebo for 12 weeks.
- Primary Outcome Measures
Name Time Method muscle strength 12 weeks the peak torque at 60°/s knee extension (/kg)
- Secondary Outcome Measures
Name Time Method appendicular skeletal mass/(height x height) 12 weeks using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks
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
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
concentration of lactate (mg/dL) 12 weeks lactate (IU/L) measured at baseline and after 12 weeks
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeungsangnam-do, Korea, Republic of