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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: Ishige Okamurae extracts group; Dietary supplement: Placebo group

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 12 weeks.	Dietary supplement: Placebo group; Placebo 300 mg/day for 12 weeks
Experimental: Ishige Okamurae extracts group; This group takes Ishige Okamurae extracts for 12 weeks.	Dietary supplement: Ishige Okamurae extracts group; Ishige Okamurae extracts 300 mg/day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle strength	the peak torque at 60°/s knee extension (/kg)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
appendicular skeletal mass/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
appendicular skeletal mass/weight x 100	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
skeletal Muscle Mass Index/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
concentration of creatinine kinase (IU/L)	creatinine kinase (IU/L) measured at baseline and after 12 weeks	12 weeks
concentration of lactate (mg/dL)	lactate (IU/L) measured at baseline and after 12 weeks	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	12 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): July 27, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 02-2020-029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No