Type 2 DiabetesPhase 1KWGNCT01699074
Acute Dose Response of Korean White Ginseng in Metabolic Syndrome or Type 2 Diabetes
A Phase 1 study testing 1 gram of White Korean Ginseng, 3 grams of White Korean Ginseng and 6 grams of White Korean Ginseng in people with Type 2 Diabetes and Metabolic Syndrome, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- 1 gram of White Korean Ginseng, 3 grams of White Korean Ginseng and 6 grams of White Korean Ginseng
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Jan 2014
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- 18-75 years old
- BMI 25-35 kg/m2
- Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR
- Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three of the following must be present:
- central obesity: waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 36 inches(female)
- dyslipidemia: TG ≥ 1.7 mmol/L (150 mg/dl);
- dyslipidemia: HDL-C < 40 mg/dL (male), < 50 mg/dL (female) blood pressure ≥ 130/85 mmHg; fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
Who cannot join
- BMI >35 kg/m2
- Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
- Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study.
- Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc).
- Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra)
- Allergy or sensitivity to the placebo (wheat bran), ginseng or gelatin used in the capsules.
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- Use of any ginseng products within three days preceding the study and during the study.
- Allergies to Panax species, their constituents or to other members of the Araliaceae family.
- The use of additional NHPs that may affect blood pressure or blood glucose Individuals suffering from glucose-galactose malabsorption syndrome.
Trial locations and contacts
1 site in 1 country.
Canada1 site
: Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Acute Dose Response Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Cardiovascular Disease Risk Factors in Individuals With Metabolic Syndrome or Type 2 Diabetes
The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2 Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria: as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be recruited for the study.
Read the detailed description
This study hypothesizes that KWG will dose dependently lower postprandial area under the curve compared to negative control, as well as will dose dependently decrease postprandial glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial blood pressure, aortic augmentation index, and mean arterial pressure, and improve left ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to control. Finally, it expects to notice an effect on subjective satiety levels and have no significant adverse effects compared to control.
- Conditions
- Type 2 Diabetes, Metabolic Syndrome
- Being tested
- 1 gram of White Korean Ginseng, 3 grams of White Korean Ginseng, 6 grams of White Korean Ginseng, 3 grams of Wheat Bran Control, 500mg of Korean Red Ginseng
- Keywords
- Korean White Ginseng, Type 2 diabetes, Metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 gram of White Korean GinsengDietary supplement
1 gram of White Korean Ginseng
3 grams of White Korean GinsengDietary supplement
3 grams of White Korean Ginseng
6 grams of White Korean GinsengDietary supplement
6 grams of White Korean Ginseng
3 grams of Wheat Bran ControlDietary supplement
3 grams of Wheat Bran Control
500mg of Korean Red GinsengDietary supplement
500mg of Korean Red Ginseng
| Study group | Role | What they receive |
|---|---|---|
| 1 gram of White Korean Ginseng | Experimental | 1 gram of White Korean Ginseng Receives: Dietary Supplement: 1 gram of White Korean Ginseng |
| 3 grams of White Korean Ginseng | Experimental | 3 grams of White Korean Ginseng Receives: Dietary Supplement: 3 grams of White Korean Ginseng |
| 6 grams of White Korean Ginseng | Experimental | 6 grams of White Korean Ginseng Receives: Dietary Supplement: 6 grams of White Korean Ginseng |
| 3 grams of Wheat Bran Control | Placebo comparator | 3 grams of Wheat Bran Control Receives: Dietary Supplement: 3 grams of Wheat Bran Control |
| 500mg of Korean Red Ginseng | Active comparator | 500mg of Korean Red Ginseng Receives: Dietary Supplement: 500mg of Korean Red Ginseng |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of KWG on vascular and glycemic measures
To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx)
Measured: 3 hours
Secondary outcomes (1)
Effect of KWG on vascular and glycemic measures
To evaluate the acute effect of Korean White ginseng treatments on peak and postprandial glycemia measures.To evaluate the acute effect of KWG treatments on aortic and brachial blood pressure To evaluate the acute effect of KWG treatments on heart rate, mean arterial pressure, left ventricular ejection duration (ED) and subendocardial viability ratio (SEVR) - a surrogate marker of myocardial perfusion
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699074
- Sponsor's protocol ID
- 182629
- Acronym
- KWG
- Status last verified
- Apr 2014
- First submitted
- 1 Oct 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
Publications
Shishtar E, Jovanovski E, Jenkins A, Vuksan V. Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Vascular and Glycemic Health in Type 2 Diabetes: Results of a Randomized, Double Blind, Placebo-controlled, Multiple-crossover, Acute Dose Escalation Trial. Clin Nutr Res. 2014 Jul;3(2):89-97. doi: 10.7762/cnr.2014.3.2.89. Epub 2014 Jul 29.
PubMed 25136536
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Dose Response Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Cardiovascular Disease Risk Factors in Individuals With Metabolic Syndrome or Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01699074
- Acronym / sponsor ID
- KWG / 182629
- Conditions
- Type 2 Diabetes, Metabolic Syndrome
- Keywords
- Korean White Ginseng, Type 2 diabetes, Metabolic syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Oct 2012 (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.
The study is a Phase-I like double blind randomized placebo controlled crossover design trial. The objective is to assess the dose response relationship on glycemic and vascular effects of an acutely administered Korean White Ginseng (KWG)(Panax C.A. Meyer) in individuals with metabolic syndrome or type 2 diabetes . Twenty seven subjects with Type 2 Diabetes (Key inclusion criteria: HbA1c ≤8.5%)or metabolic syndrome (Key inclusion criteria: as defined by The US National Cholesterol Education Program Adult Treatment Panel III)will be recruited for the study.
Detailed description
This study hypothesizes that KWG will dose dependently lower postprandial area under the curve compared to negative control, as well as will dose dependently decrease postprandial glycemia. It also assumes that use of KWG will dose dependently decrease aortic and brachial blood pressure, aortic augmentation index, and mean arterial pressure, and improve left ventricular ejection duration(ED) and subendocardial viability ratio (SEVR) compared to control. Finally, it expects to notice an effect on subjective satiety levels and have no significant adverse effects compared to control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 gram of White Korean Ginseng | Experimental | Dietary Supplement: 1 gram of White Korean Ginseng1 gram of White Korean Ginseng |
| 3 grams of White Korean Ginseng | Experimental | Dietary Supplement: 3 grams of White Korean Ginseng3 grams of White Korean Ginseng |
| 6 grams of White Korean Ginseng | Experimental | Dietary Supplement: 6 grams of White Korean Ginseng6 grams of White Korean Ginseng |
| 3 grams of Wheat Bran Control | Placebo comparator | Dietary Supplement: 3 grams of Wheat Bran Control3 grams of Wheat Bran Control |
| 500mg of Korean Red Ginseng | Active comparator | Dietary Supplement: 500mg of Korean Red Ginseng500mg of Korean Red Ginseng |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women
- 18-75 years old
- BMI 25-35 kg/m2
- Presence of type 2 diabetes (as defined by HbA1c ≤8.5%),treatment with diet or oral hypoglycemic medication) OR
- Presence of Metabolic Syndrome as defined by The US National Cholesterol -Education Program Adult Treatment Panel III (NCEP III). As per NCEP III criteria, at least three of the following must be present:
Key exclusion criteria (9 listed)
- BMI >35 kg/m2
- Hypertensive (brachial systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg)
- Pregnant women, or those at risk of pregnancy, or breastfeeding at the time of the study.
- Women of childbearing age that do not use acceptable method of birth control (ie. abstinence, implants, injectables, oral contraceptives, IUDs etc).
- Chronic conditions including: liver disease, cancer, heavy alcohol use, bleeding disorders, history of angina, congestive heart failure, coronary revascularization, peripheral vascular disease, retinopathy, kidney disease or coronary/cerebrovascular event; chronic use of medications including blood-thinners, SSRIs, MAO inhibitors, medications affecting NO synthesis (eg. Viagra)
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 |
|---|---|---|
| 1 gram of White Korean Ginseng1 gram of White Korean Ginseng | Dietary supplement | 1 gram of White Korean Ginseng |
| 3 grams of White Korean Ginseng3 grams of White Korean Ginseng | Dietary supplement | 3 grams of White Korean Ginseng |
| 6 grams of White Korean Ginseng6 grams of White Korean Ginseng | Dietary supplement | 6 grams of White Korean Ginseng |
| 3 grams of Wheat Bran Control3 grams of Wheat Bran Control | Dietary supplement | 3 grams of Wheat Bran Control |
| 500mg of Korean Red Ginseng500mg of Korean Red Ginseng | Dietary supplement | 500mg of Korean Red Ginseng |
Primary outcome
Effect of KWG on vascular and glycemic measures
Time frame: 3 hours
To evaluate the acute dose response effect of KWG on blood glucose Area under the Curve (AUC) compared to controls in individuals with Metabolic syndrome or Type 2 Diabetes To evaluate the acute effect of KWG treatments on arterial stiffness as measured by aortic augmentation index (AIx)
1 secondary outcome
Effect of KWG on vascular and glycemic measures
Time frame: 4 hours
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 Apr 2014.
- Derived from this study: PubMed 25136536Shishtar E, Jovanovski E, Jenkins A, Vuksan V. Effects of Korean White Ginseng (Panax Ginseng C.A. Meyer) on Vascular and Glycemic Health in Type 2 Diabetes: Results of a Randomized, Double Blind, Placebo-controlled, Multiple-crossover, Acute Dose Escalation Trial. Clin Nutr Res. 2014 Jul;3(2):89-97. doi: 10.7762/cnr.2014.3.2.89. Epub 2014 Jul 29.
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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 Phase 1 study testing 1 gram of White Korean Ginseng, 3 grams of White Korean Ginseng and 6 grams of White Korean Ginseng in people with Type 2 Diabetes and Metabolic Syndrome, run by Unity Health Toronto at 1 site in Canada.
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 8 inclusion and 9 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 Apr 2014. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of KWG on vascular and glycemic measures (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699074, which also lists 1 linked publication.
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 Apr 2014.