HyperglycemiaNCT01854164
Efficacy and Safety of Hydrolyzed Ginseng Extract on Impaired Fasting Glucose
A study testing HGE (hydrolyzed ginseng extract) in people with Hyperglycemia, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- HGE (hydrolyzed ginseng extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-70 years with fasting glucose 100~126 mg/dL
Who cannot join
- Abnormal lipid profile values
- Acute/chronic inflammation
- Treated with corticosteroid within past 4 weeks
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
- History of disease that could interfere with the test products or impede their absorption
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- Participation in any other clinical trials within past 2 months
- Renal disease
- Abnormal hepatic function
- Under hypolipidemic drugs therapy within past 3 months
- Under antipsychotic drugs therapy within past 2 months
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- History of alcohol or substance abuse
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 560-822
About this study
Official title: An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).
Read the detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
- Conditions
- Hyperglycemia
- Being tested
- HGE (hydrolyzed ginseng extract), Placebo
- Keywords
- HGE, impaired fasting glucose, clinical trial
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGE (hydrolyzed ginseng extract)Dietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| HGE(hydrolyzed ginseng extract) | Experimental | HGE capsules(2cap/d, 960mg/d) for 8 weeks. Receives: Dietary Supplement: HGE (hydrolyzed ginseng extract) |
| Placebo | Placebo comparator | Placebo for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose during OGTT(oral glucose tolerance test)
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
Measured: 8 weeks
Secondary outcomes (2)
Changes of blood insulin during OGTT.
Changes of blood insulin during OGTT were assessed before(baseline) and after the intervention.
Measured: 8 weeks
Changes of glycated albumin, fructosamine, and lipid profile
Changes of glycated albumin, fructosamine, and lipid profile were assessed before(baseline) and after the intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854164
- Sponsor's protocol ID
- Ilhwa-FG-001
- Status last verified
- Mar 2016
- First submitted
- 13 May 2013
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
- ClinicalTrials.gov ID
- NCT01854164
- Acronym / sponsor ID
- Ilhwa-FG-001
- Conditions
- Hyperglycemia
- Keywords
- HGE, impaired fasting glucose, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).
Detailed description
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGE(hydrolyzed ginseng extract) | Experimental | Dietary Supplement: HGE (hydrolyzed ginseng extract)HGE capsules(2cap/d, 960mg/d) for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo for 8 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 20-70 years with fasting glucose 100~126 mg/dL
Key exclusion criteria (14 listed)
- Abnormal lipid profile values
- Acute/chronic inflammation
- Treated with corticosteroid within past 4 weeks
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGE (hydrolyzed ginseng extract) | Dietary supplement | HGE(hydrolyzed ginseng extract) |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Changes of blood glucose during OGTT(oral glucose tolerance test)
Time frame: 8 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
2 secondary outcomes
Changes of blood insulin during OGTT.
Time frame: 8 weeks
Changes of glycated albumin, fructosamine, and lipid profile
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGE (hydrolyzed ginseng extract) in people with Hyperglycemia, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose during OGTT(oral glucose tolerance test) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2016.