Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia

Pusan National University Yangsan Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sarcopenia

Interventions

Ishige Okamurae extracts groupDIETARY_SUPPLEMENT

Ishige Okamurae extracts 300 mg/day for 12 weeks

Placebo groupDIETARY_SUPPLEMENT

Placebo 300 mg/day for 12 weeks

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

muscle strength

the peak torque at 60°/s knee extension (/kg)

Time frame: 12 weeks

Secondary Outcomes

appendicular skeletal mass/(height x height)

using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

Time frame: 12 weeks

appendicular skeletal mass/weight x 100

using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

Time frame: 12 weeks

skeletal Muscle Mass Index/(height x height)

using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks

Time frame: 12 weeks

concentration of creatinine kinase (IU/L)

creatinine kinase (IU/L) measured at baseline and after 12 weeks

Time frame: 12 weeks

concentration of lactate (mg/dL)

lactate (IU/L) measured at baseline and after 12 weeks

Time frame: 12 weeks

EuroQol five dimensional three levels

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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