Efficacy and safety of enzyme-treated green tea catechin extract on muscle function

12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of enzyme-treated green tea catechin extract on muscle function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004777

Enrollment

Registered

2020-02-28

Start date

2018-07-04

Completion date

Unknown

Last updated

2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : - Enzyme-treated green tea catechin extract group: twice a day, 1 capsule at a time, after breakfast or dinner, for 12 weeks (720 mg/day, 600mg/day for enzyme-treated green tea ca

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 60 years over at the screening examination 2) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1) Patients with a clinically significant disease requiring treatment (i.e., severe cardiovascular system, endocrine system, neuropsychiatric system, musculoskeletal inflammation, gastrointestinal disease, inflammatory disease, blood and tumor disease, etc.) 2) Patients who take medicine or health functional food for myofunction within a month prior to the screening examination 3) Patients with a history of antipsychotic medication use within 2 months prior to the screening examination 4)Patients who have participated in other clinical trials within 2 months prior to the screening examination 5)Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
Isokinetic muscular strength;Grip;Muscle mass	—

Secondary

Measure	Time frame
Short Physical Performance Battery;Muscle-related hormones;Composite score;Cytokines;Growth-related hormones;hs-CRP(high sensitive C reaction protein);Stress-related hormones;WHOQOL-BREF(World Health Organization Quality of Life-BREF)	—

Countries

Korea, Republic of

Contacts

Public ContactGi-Wook Kim

Chonbuk National University Hospital

Outcome results