Effects of Ginsenoside Supplementation on Insulin Resistance and Cardiometabolic Risk Factors in Men With Metabolic Syndrome: a Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- CHA University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change from baseline in metabolic syndrome profile at week 4
Study Overview
Brief Summary
Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose.
Randomized Control Trial.
Detailed Description
Methods : A randomized, double-blind, placebo-controlled, single-center study in 60 subjects who are not taking drugs that could affect metabolic and vascular function. Subjects will be randomized into a Korean red ginseng (3.0g/d) group or placebo group for a 4-week study.
We will collect anthropometric measurements, blood for laboratory testing, inflammatory marker, hormones and mitochondrial DNA copy number.
Subject : Older than 40 years of age, presented with metabolic syndrome. Subjects were excluded if they were taking drugs that could affect metabolic and vascular function, including BP control drug, anti-diabetic drugs and lipid-lowering drugs.
Measurement : We will collect anthropometric measurements and blood for laboratory testing at the initial(week 0) and final (week 4)visits. Serum levels of blood glucose, insulin, total cholesterol, HDL-cholesterol,triglyceride, and DNA copy number of mitochondria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •metabolic syndrome
Exclusion Criteria
- •Taking drug for lipid-lowering, BP control and anti-diabetic.
Arms & Interventions
Dietary fiber fill
Dietary fiber fill manufactured to mimic Ginsenoside tablet
Intervention: Dietary fiber fill (Dietary Supplement)
Outcomes
Primary Outcomes
Change from baseline in metabolic syndrome profile at week 4
Time Frame: Baseline and 4 weeks from intake of Ginsenoside
Total cholesterol, HDL-Cholesterol, Glucose, Blood Pressure, Body weight
Secondary Outcomes
- Change from baseline in hormones at week 4.(Initial and 4 weeks later)
Investigators
Dong-Hyuk Jung
Assistant professor, Family medicine
CHA University