Vladimir Vuksan1,2,3,4,5, Zenith Zheng Xu6,7, Elena Jovanovski6,7, Alexandra L Jenkins6, Uljana Beljan-Zdravkovic6, John L Sievenpiper6,8,7,9, P Mark Stavro6,7, Andreea Zurbau6,7, Lea Duvnjak10, Michael Z C Li11. 1. Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, ON, Canada. v.vuksan@utoronto.ca. 2. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. v.vuksan@utoronto.ca. 3. Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada. v.vuksan@utoronto.ca. 4. Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada. v.vuksan@utoronto.ca. 5. Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, ON, Canada. v.vuksan@utoronto.ca. 6. Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital, Toronto, ON, Canada. 7. Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, ON, Canada. 8. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, ON, Canada. 9. Division of Endocrinology & Metabolism, St. Michael's Hospital, Toronto, ON, Canada. 10. Vuk Vrhovac Clinic for Diabetes, Endocrinology and Metabolic Diseases-UH Merkur, School of Medicine, University of Zagreb, Zagreb, Croatia. 11. Chai-Na-Ta Corp., Langley, BC, Canada.
Abstract
PURPOSE: Despite the lack of evidence, a growing number of people are using herbal medicine to attenuate the burden of diabetes. There is an urgent need to investigate the clinical potential of herbs. Preliminary observations suggest that American ginseng (Panax quinquefolius [AG]) may reduce postprandial glycemia. Thus, we aimed to evaluate the efficacy and safety of AG as an add-on therapy in individuals with type 2 diabetes (T2DM) controlled by conventional treatment. METHODS:24 individuals living with T2DM completed the study (F:M = 11:13; age = 64 ± 7 year; BMI = 27.8 ± 4.6 kg/m2; HbA1c = 7.1 ± 1.2%). Utilizing a double-blind, cross-over design, the participants were randomized to receive either 1 g/meal (3 g/day) of AG extract or placebo for 8 weeks while maintaining their original treatment. Following a ≥ 4-week washout period, the participants were crossed over to the opposite 8-week treatment arm. The primary objective was HbA1c, and secondary endpoints included fasting blood glucose and insulin, blood pressure, plasma lipids, serum nitrates/nitrites (NOx), and plasominogen-activating factor-1 (PAI-1). Safety parameters included liver and kidney function. RESULTS: Compared to placebo, AG significantly reduced HbA1c (- 0.29%; p = 0.041) and fasting blood glucose (- 0.71 mmol/L; p = 0.008). Furthermore, AG lowered systolic blood pressure (- 5.6 ± 2.7 mmHg; p < 0.001), increased NOx (+ 1.85 ± 2.13 µmol/L; p < 0.03), and produced a mean percent end-difference of - 12.3 ± 3.9% in LDL-C and - 13.9 ± 5.8% in LDL-C/HDL. The safety profiles were unaffected. CONCLUSIONS: AG extract added to conventional treatment provided an effective and safe adjunct in the management of T2DM. Larger studies using physiologically standardized ginseng preparations are warranted to substantiate the present findings and to demonstrate therapeutic effectiveness of AG. CLINICALTRIALS. GOV IDENTIFIER: NCT02923453.
RCT Entities:
PURPOSE: Despite the lack of evidence, a growing number of people are using herbal medicine to attenuate the burden of diabetes. There is an urgent need to investigate the clinical potential of herbs. Preliminary observations suggest that American ginseng (Panax quinquefolius [AG]) may reduce postprandial glycemia. Thus, we aimed to evaluate the efficacy and safety of AG as an add-on therapy in individuals with type 2 diabetes (T2DM) controlled by conventional treatment. METHODS: 24 individuals living with T2DM completed the study (F:M = 11:13; age = 64 ± 7 year; BMI = 27.8 ± 4.6 kg/m2; HbA1c = 7.1 ± 1.2%). Utilizing a double-blind, cross-over design, the participants were randomized to receive either 1 g/meal (3 g/day) of AG extract or placebo for 8 weeks while maintaining their original treatment. Following a ≥ 4-week washout period, the participants were crossed over to the opposite 8-week treatment arm. The primary objective was HbA1c, and secondary endpoints included fasting blood glucose and insulin, blood pressure, plasma lipids, serum nitrates/nitrites (NOx), and plasominogen-activating factor-1 (PAI-1). Safety parameters included liver and kidney function. RESULTS: Compared to placebo, AG significantly reduced HbA1c (- 0.29%; p = 0.041) and fasting blood glucose (- 0.71 mmol/L; p = 0.008). Furthermore, AG lowered systolic blood pressure (- 5.6 ± 2.7 mmHg; p < 0.001), increased NOx (+ 1.85 ± 2.13 µmol/L; p < 0.03), and produced a mean percent end-difference of - 12.3 ± 3.9% in LDL-C and - 13.9 ± 5.8% in LDL-C/HDL. The safety profiles were unaffected. CONCLUSIONS:AG extract added to conventional treatment provided an effective and safe adjunct in the management of T2DM. Larger studies using physiologically standardized ginseng preparations are warranted to substantiate the present findings and to demonstrate therapeutic effectiveness of AG. CLINICALTRIALS. GOV IDENTIFIER: NCT02923453.
Authors: Andreea Zurbau; Lea Smircic Duvnjak; Sasa Magas; Elena Jovanovski; Jelena Miocic; Alexandra L Jenkins; David J A Jenkins; Robert G Josse; Lawrence A Leiter; John L Sievenpiper; Vladimir Vuksan Journal: Eur J Nutr Date: 2021-01-24 Impact factor: 5.614
Authors: Hassan A Alhazmi; Asim Najmi; Sadique A Javed; Shahnaz Sultana; Mohammed Al Bratty; Hafiz A Makeen; Abdulkarim M Meraya; Waquar Ahsan; Syam Mohan; Manal M E Taha; Asaad Khalid Journal: Front Immunol Date: 2021-05-13 Impact factor: 7.561
Authors: Elena Jovanovski; Lea Smircic-Duvnjak; Allison Komishon; Fei Rodney Au-Yeung; John L Sievenpiper; Andreea Zurbau; Alexandra L Jenkins; Mi-Kyung Sung; Robert Josse; Dandan Li; Vladimir Vuksan Journal: J Ginseng Res Date: 2019-11-14 Impact factor: 6.060