Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

NCT03775733 | Unknown DMC

• 1 other identifier: GH-HG-HR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

Conditions

Hyperglycemia

Keywords

Hydrolysed red ginseng extract; Glucose; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Changes of blood glucose

  Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.

  12 weeks

Secondary Outcomes (7)

• Changes of blood insulin

  12 weeks

• Changes of area under the curve of Glucose and Insulin

  12 weeks

• Changes of Homeostatic model assessment-insulin resistance

  12 weeks

• Changes of Homeostatic model assessment-beta-cell

  12 weeks

• Changes of HbA1c

  12 weeks

Study Arms (2)

Hydrolysed red ginseng extract

EXPERIMENTAL

Hydrolysed red ginseng extract 2.4g/day for 12 weeks

Dietary Supplement: Hydrolysed Red Ginseng Extract

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Dietary Supplement: Placebo

Interventions

Hydrolysed Red Ginseng Extract DIETARY_SUPPLEMENT

Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.

Hydrolysed red ginseng extract

Placebo DIETARY_SUPPLEMENT

Placebo for 12 weeks.

Placebo

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-80 years with fasting glucose 100-140 mg/dL

You may not qualify if:

• Weight less than 48 kg or weight decreased by more than 10% within past 3 months
• Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
• Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
• Blood sugar improvement or healthy functional food within past 1 month
• Under antipsychotic medication therapy within past 2 months
• History of alcohol or substance abuse
• Participation in any other clinical trials within past 2 months
• Laboratory test by show the following results
• aspartate aminotransferase, alanine aminotransferase \> Reference range 3 times upper limit
• Serum Creatinine \> 2.0 mg/dl
• Pregnancy or breast feeding
• If a woman of childbearing doesn't accept the implementation of appropriate contraception
• Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: September 7, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 31, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

KR (1)