The efficacy and safety of Dendropanax morbifera leaf extract on the metabolic syndrome: a 12-week, placebo controlled, double blind, and randomized controlled trial

Ji Eun Jun; You-Cheol Hwang; Kyu Jeung Ahn; Ho Yeon Chung; Se Young Choung; In-Kyung Jeong

doi:10.4162/nrp.2022.16.1.60

The efficacy and safety of Dendropanax morbifera leaf extract on the metabolic syndrome: a 12-week, placebo controlled, double blind, and randomized controlled trial

Nutr Res Pract. 2022 Feb;16(1):60-73. doi: 10.4162/nrp.2022.16.1.60. Epub 2021 Jun 29.

Authors

Ji Eun Jun¹, You-Cheol Hwang¹, Kyu Jeung Ahn¹, Ho Yeon Chung¹, Se Young Choung², In-Kyung Jeong¹

Affiliations

¹ Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea.
² Department of Preventive Pharmacy and Toxicology, Department of Life and Nanopharmaceutical Sciences of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea.

Abstract

Background/objectives: The extract from Dendropanax morbifera exhibited diverse therapeutic potentials. We aimed to evaluate the efficacy and safety of D. morbifera leaf extract for improving metabolic parameters in human.

Subjects/methods: A 12-week, double blind, placebo-controlled and randomized trial included a total of 74 adults, and they were assigned to the placebo group (n = 38) or 700 mg/day of D. morbifera group (n = 36). The efficacy endpoints were changes in glycemic, lipid, obesity, and blood pressure (BP) parameters, in addition to the prevalence of metabolic syndrome (MetS) and the numbers of MetS components. Safety was assessed by monitoring adverse events (AEs).

Results: After 12 weeks of treatment, the hemoglobin A1c (HbA1c) level significantly decreased in the D. morbifera group compared to that of the placebo group (difference: -0.13 ± 0.20% vs. 0.00 ± 0.28%, P = 0.031; % of change: -2.27 ± 3.63% vs. 0.10 ± 5.10%, P = 0.025). The homeostatic model assessment for insulin resistance level also decreased significantly from its baseline in the D. morbifera group. The systolic BP of D. morbifera group decreased significantly than that of placebo group (difference: -3.9 ± 9.8 mmHg vs. 3.3 ± 11.7 mmHg, P = 0.005; % of change: -2.8 ± 7.7% vs. 3.3 ± 10.2%, P = 0.005). However, the lipid parameters and body composition including body weight did not differ between the groups. The prevalence of MetS (36.8% vs. 13.9%, P = 0.022) and the incidence of MetS (10.5% vs. 13.9%, P = 0.027) at 12 weeks was significantly lower in the D. morbifera group than it was in the placebo group. No serious AEs occurred in either group.

Conclusions: Supplementation with D. morbifera extracts over a 12-week period improved metabolic parameters such as HbA1c and BP and reduced the prevalence of MetS.

Trial registration: Clinical Research Information Service Identifier: KCT0004672.

Keywords: Metabolic syndrome; functional food; glucose; hypertension.