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NCT Number: NCT04617951

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ishige Okamurae extracts group

Dietary Supplement

Ishige Okamurae extracts 300 mg/day for 12 weeks

Placebo Group

Dietary Supplement

Placebo 300 mg/day for 12 weeks

Primary outcomes

  1. muscle strength

    Time frame: 12 weeks

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

Secondary outcomes

  1. appendicular skeletal mass/(height x height)

    Time frame: 12 weeks

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

  2. appendicular skeletal mass/weight x 100

    Time frame: 12 weeks

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

  3. skeletal Muscle Mass Index/(height x height)

    Time frame: 12 weeks

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

  4. concentration of creatinine kinase (IU/L)

    Time frame: 12 weeks

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

  5. concentration of lactate (mg/dL)

    Time frame: 12 weeks

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

  6. EuroQol five dimensional three levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia: a Randomized, Double-blinded, Placebo-controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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