- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02923453
Effect of Ginseng in Type 2 Diabetes
October 3, 2016 updated by: Unity Health Toronto
Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial
Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment.
Materials and Methods: A total of 23 type 2 patients are enrolled in the study.
Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment.
Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm.
Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle.
The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1.
Safety parameters include liver, kidney and hemostatic functions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of type 2 diabetes of ≥1 year duration
- BMI between 25-35kg/m^2
- HbA1c between 6.5-8.5%
Exclusion Criteria:
- Patients on insulin therapy
- Impaired hepatic or renal function
- Clinically manifested diabetic complications
- Present cardiac problems
- Uncontrolled hypoglycemia
- Cigarette smokers
- Alcohol consumption (>2 drinks per week)
- Taking ginseng or other herb with possible hypoglycemic effect
- Involvement in any other investigational drug studies
- Changed medication during the course of the study periods or during the washout period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
1g/meal of placebo three times per day (3g/day) for 8-weeks.
|
|
Active Comparator: Ginseng Extract
CNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: 8 weeks
|
8 weeks
|
Fasting blood glucose
Time Frame: 8 weeks
|
8 weeks
|
Fasting blood insulin
Time Frame: 8 weeks
|
8 weeks
|
serum nitrates/nitrites (NOx)
Time Frame: 8 weeks
|
8 weeks
|
Plasminogen activator inhibitor-1 (PAI-1)
Time Frame: 8 weeks
|
8 weeks
|
Alanine amino-transferase (ALT)
Time Frame: 8 weeks
|
8 weeks
|
serum creatinine
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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- Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. No abstract available. Erratum In: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.
- Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681. Erratum In: N Engl J Med. 2009 Dec 31;361(27):2681.
- Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2015 Jan;38(1):140-9. doi: 10.2337/dc14-2441. No abstract available.
- Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
- Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
- Van Gaal L, Scheen A. Weight management in type 2 diabetes: current and emerging approaches to treatment. Diabetes Care. 2015 Jun;38(6):1161-72. doi: 10.2337/dc14-1630.
- Bacon L, Aphramor L. Weight science: evaluating the evidence for a paradigm shift. Nutr J. 2011 Jan 24;10:9. doi: 10.1186/1475-2891-10-9. Erratum In: Nutr J. 2011;10:69.
- Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, Bravata DM. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003 Apr 9;289(14):1837-50. doi: 10.1001/jama.289.14.1837.
- Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.
- Post RE, Mainous AG 3rd, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012 Jan-Feb;25(1):16-23. doi: 10.3122/jabfm.2012.01.110148.
- Johnston BC, Kanters S, Bandayrel K, Wu P, Naji F, Siemieniuk RA, Ball GD, Busse JW, Thorlund K, Guyatt G, Jansen JP, Mills EJ. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA. 2014 Sep 3;312(9):923-33. doi: 10.1001/jama.2014.10397.
- Buckley JD, Howe PRC. Long-chain omega-3 polyunsaturated fatty acids may be beneficial for reducing obesity-a review. Nutrients. 2010 Dec;2(12):1212-1230. doi: 10.3390/nu2121212. Epub 2010 Dec 9.
- Valdivia-Lopez MA, Tecante A. Chia (Salvia hispanica): A Review of Native Mexican Seed and its Nutritional and Functional Properties. Adv Food Nutr Res. 2015;75:53-75. doi: 10.1016/bs.afnr.2015.06.002. Epub 2015 Aug 5.
- Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.
- Bazinet RP, McMillan EG, Cunnane SC. Dietary alpha-linolenic acid increases the n-3 PUFA content of sow's milk and the tissues of the suckling piglet. Lipids. 2003 Oct;38(10):1045-9. doi: 10.1007/s11745-006-1159-9.
- Katsuki A, Urakawa H, Gabazza EC, Murashima S, Nakatani K, Togashi K, Yano Y, Adachi Y, Sumida Y. Circulating levels of active ghrelin is associated with abdominal adiposity, hyperinsulinemia and insulin resistance in patients with type 2 diabetes mellitus. Eur J Endocrinol. 2004 Nov;151(5):573-7. doi: 10.1530/eje.0.1510573.
- Chandran M, Phillips SA, Ciaraldi T, Henry RR. Adiponectin: more than just another fat cell hormone? Diabetes Care. 2003 Aug;26(8):2442-50. doi: 10.2337/diacare.26.8.2442. No abstract available.
- Guo Y, Ma L, Enriori PJ, Koska J, Franks PW, Brookshire T, Cowley MA, Salbe AD, Delparigi A, Tataranni PA. Physiological evidence for the involvement of peptide YY in the regulation of energy homeostasis in humans. Obesity (Silver Spring). 2006 Sep;14(9):1562-70. doi: 10.1038/oby.2006.180.
- Stenlof K, Rossner S, Vercruysse F, Kumar A, Fitchet M, Sjostrom L; OBDM-003 Study Group. Topiramate in the treatment of obese subjects with drug-naive type 2 diabetes. Diabetes Obes Metab. 2007 May;9(3):360-8. doi: 10.1111/j.1463-1326.2006.00618.x.
- Hensrud DD. Dietary treatment and long-term weight loss and maintenance in type 2 diabetes. Obes Res. 2001 Nov;9 Suppl 4:348S-353S. doi: 10.1038/oby.2001.141.
- Vilsboll T, Zdravkovic M, Le-Thi T, Krarup T, Schmitz O, Courreges JP, Verhoeven R, Buganova I, Madsbad S. Liraglutide, a long-acting human glucagon-like peptide-1 analog, given as monotherapy significantly improves glycemic control and lowers body weight without risk of hypoglycemia in patients with type 2 diabetes. Diabetes Care. 2007 Jun;30(6):1608-10. doi: 10.2337/dc06-2593. Epub 2007 Mar 19. No abstract available.
- Nieman DC, Cayea EJ, Austin MD, Henson DA, McAnulty SR, Jin F. Chia seed does not promote weight loss or alter disease risk factors in overweight adults. Nutr Res. 2009 Jun;29(6):414-8. doi: 10.1016/j.nutres.2009.05.011.
- Ayerza R, Coates W. Dietary levels of chia: influence on yolk cholesterol, lipid content and fatty acid composition for two strains of hens. Poult Sci. 2000 May;79(5):724-39. doi: 10.1093/ps/79.5.724.
- Ayerza R. The seed's protein and oil content, fatty acid composition, and growing cycle length of a single genotype of chia (Salvia hispanica L.) as affected by environmental factors. J Oleo Sci. 2009;58(7):347-54. doi: 10.5650/jos.58.347.
- Vuksan V, Jenkins AL, Dias AG, Lee AS, Jovanovski E, Rogovik AL, Hanna A. Reduction in postprandial glucose excursion and prolongation of satiety: possible explanation of the long-term effects of whole grain Salba (Salvia Hispanica L.). Eur J Clin Nutr. 2010 Apr;64(4):436-8. doi: 10.1038/ejcn.2009.159. Epub 2010 Jan 20.
- Nieman DC, Gillitt N, Jin F, Henson DA, Kennerly K, Shanely RA, Ore B, Su M, Schwartz S. Chia seed supplementation and disease risk factors in overweight women: a metabolomics investigation. J Altern Complement Med. 2012 Jul;18(7):700-8. doi: 10.1089/acm.2011.0443.
- Sahakyan KR, Somers VK, Rodriguez-Escudero JP, Hodge DO, Carter RE, Sochor O, Coutinho T, Jensen MD, Roger VL, Singh P, Lopez-Jimenez F. Normal-Weight Central Obesity: Implications for Total and Cardiovascular Mortality. Ann Intern Med. 2015 Dec 1;163(11):827-35. doi: 10.7326/M14-2525. Epub 2015 Nov 10.
- Rao AD, Milbrandt EB. To JUPITER and beyond: statins, inflammation, and primary prevention. Crit Care. 2010;14(3):310. doi: 10.1186/cc9006. Epub 2010 May 13. No abstract available.
- Kinlay S. Low-density lipoprotein-dependent and -independent effects of cholesterol-lowering therapies on C-reactive protein: a meta-analysis. J Am Coll Cardiol. 2007 May 22;49(20):2003-9. doi: 10.1016/j.jacc.2007.01.083. Epub 2007 May 4.
- Jenkins DJ, Kendall CW, Vuksan V. Viscous fibers, health claims, and strategies to reduce cardiovascular disease risk. Am J Clin Nutr. 2000 Feb;71(2):401-2. doi: 10.1093/ajcn/71.2.401. No abstract available.
- Roberfroid MB. Inulin-type fructans: functional food ingredients. J Nutr. 2007 Nov;137(11 Suppl):2493S-2502S. doi: 10.1093/jn/137.11.2493S.
- Detopoulou P, Panagiotakos DB, Chrysohoou C, Fragopoulou E, Nomikos T, Antonopoulou S, Pitsavos C, Stefanadis C. Dietary antioxidant capacity and concentration of adiponectin in apparently healthy adults: the ATTICA study. Eur J Clin Nutr. 2010 Feb;64(2):161-8. doi: 10.1038/ejcn.2009.130. Epub 2009 Nov 11.
- Mohammadi E, Rafraf M, Farzadi L, Asghari-Jafarabadi M, Sabour S. Effects of omega-3 fatty acids supplementation on serum adiponectin levels and some metabolic risk factors in women with polycystic ovary syndrome. Asia Pac J Clin Nutr. 2012;21(4):511-8.
- Vuksan V, Rogovik AL, Jovanovski E, Jenkins AL. Fiber facts: benefits and recommendations for individuals with type 2 diabetes. Curr Diab Rep. 2009 Oct;9(5):405-11. doi: 10.1007/s11892-009-0062-1.
- Wanders AJ, van den Borne JJ, de Graaf C, Hulshof T, Jonathan MC, Kristensen M, Mars M, Schols HA, Feskens EJ. Effects of dietary fibre on subjective appetite, energy intake and body weight: a systematic review of randomized controlled trials. Obes Rev. 2011 Sep;12(9):724-39. doi: 10.1111/j.1467-789X.2011.00895.x. Epub 2011 Jun 16.
- Jiao J, Xu JY, Zhang W, Han S, Qin LQ. Effect of dietary fiber on circulating C-reactive protein in overweight and obese adults: a meta-analysis of randomized controlled trials. Int J Food Sci Nutr. 2015 Feb;66(1):114-9. doi: 10.3109/09637486.2014.959898. Epub 2015 Jan 12.
- Vuksan V, Xu ZZ, Jovanovski E, Jenkins AL, Beljan-Zdravkovic U, Sievenpiper JL, Mark Stavro P, Zurbau A, Duvnjak L, Li MZC. Efficacy and safety of American ginseng (Panax quinquefolius L.) extract on glycemic control and cardiovascular risk factors in individuals with type 2 diabetes: a double-blind, randomized, cross-over clinical trial. Eur J Nutr. 2019 Apr;58(3):1237-1245. doi: 10.1007/s00394-018-1642-0. Epub 2018 Feb 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1998
Primary Completion (Actual)
December 1, 2001
Study Completion (Actual)
August 1, 2002
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimate)
October 4, 2016
Study Record Updates
Last Update Posted (Estimate)
October 4, 2016
Last Update Submitted That Met QC Criteria
October 3, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNT 2000
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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