Hypoglycemic Effects of Fermented Red Ginseng in Subject... | NCT01826409

Studies
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

NCT01826409

Sponsor

Chonbuk National University Hospital

Status

Completed

Last Update Posted

Aug 29, 2013Estimated

Enrollment

42Actual

Phase

Phase 2Phase 3

Conditions

Impaired Glucose or Type 2 Diabetes

Interventions

Fermented Red Ginseng
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Not provided

First Submitted Date

Apr 4, 2013

First Submission Date that Met QC Criteria

Apr 5, 2013

First Posted Date

Apr 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2013

Last Update Posted Date

Aug 29, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University HospitalPrincipal Investigator

Lead Sponsor

Chonbuk National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

Detailed Description

This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fermented red ginseng	Experimental		Dietary Supplement: Fermented Red Ginseng
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fermented Red Ginseng	Dietary Supplement	Fermented red ginseng 2.7g/day for 4 weeks	Fermented red ginseng

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose profiles during meal tolerance test	Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in lipid profiles	Change in lipid profiles were assessed before(baseline) and after the intervention	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-75 years with fasting glucose 100~140 mg/dL at least two of the following

Exclusion Criteria:

Lipid metabolic disorder
Acute or chronic inflammatory disease
Taking medication of corticosteroid within 4 weeks of the study
Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
Allergic or hypersensitive to any of the ingredients in the test products
Participation in other clinical trials within 2 months
Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
Taking medication of lipid phosphates within 3 months of the study etc,

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tae Sun Park, MD., PhD	Chonbuk National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clincial Trial Center for Functional Foods		Jeonju	Jeollabok-do	560-822	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25015735	Derived	Oh MR, Park SH, Kim SY, Back HI, Kim MG, Jeon JY, Ha KC, Na WT, Cha YS, Park BH, Park TS, Chae SW. Postprandial glucose-lowering effects of fermented red ginseng in subjects with impaired fasting glucose or type 2 diabetes: a randomized, double-blind, placebo-controlled clinical trial. BMC Complement Altern Med. 2014 Jul 11;14:237. doi: 10.1186/1472-6882-14-237.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases