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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04617951
• Other study ID #: 02-2020-029
• Status: Completed
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2023
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 30, 2021
• Est. primary completion date: July 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Ishige Okamurae extracts group
Ishige Okamurae extracts 300 mg/day for 12 weeks
• Placebo group
Placebo 300 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength	the peak torque at 60°/s knee extension (/kg)	12 weeks
Secondary	appendicular skeletal mass/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	appendicular skeletal mass/weight x 100	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	skeletal Muscle Mass Index/(height x height)	using dual-energy X-ray absorptiometry measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of creatinine kinase (IU/L)	creatinine kinase (IU/L) measured at baseline and after 12 weeks	12 weeks
Secondary	concentration of lactate (mg/dL)	lactate (IU/L) measured at baseline and after 12 weeks	12 weeks
Secondary	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