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CompletedNCT04617951Updated Apr 18, 2023

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

An interventional study of Ishige Okamurae extracts group and Placebo group in Sarcopenia, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 80 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Ishige Okamurae extracts group

    This group takes Ishige Okamurae extracts for 12 weeks.

    Dietary Supplement: Ishige Okamurae extracts group

  • Placebo comparator
    Placebo group

    This group takes placebo for 12 weeks.

    Dietary Supplement: Placebo group

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

06

What researchers measure

Primary outcomes

  1. muscle strength

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

    Time frame: 12 weeks

Secondary outcomes

  1. appendicular skeletal mass/(height x height)

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

    Time frame: 12 weeks

  2. appendicular skeletal mass/weight x 100

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

  4. concentration of creatinine kinase (IU/L)

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

    Time frame: 12 weeks

  5. concentration of lactate (mg/dL)

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

    Time frame: 12 weeks

  6. 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

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeungsangnam-do 50612, Korea, Republic of
08

References and documents

Publications

  • Lee SR, Lee YL, Lee SY. Effect of Ishige okamurae extract on musculoskeletal biomarkers in adults with relative sarcopenia: Study protocol for a randomized double-blind placebo-controlled trial. Front Nutr. 2022 Sep 27;9:1015351. doi: 10.3389/fnut.2022.1015351. eCollection 2022. PubMed 36238450 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04617951
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sang Yeoup Lee (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Nov 5, 2020
Start date
Oct 23, 2020
Primary completion
Jul 27, 2021
Completion
Jul 30, 2021
Last update
Apr 18, 2023

Study contacts

Sang Yeoup Lee, MD, PhD
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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