Nutr Res Pract.  2022 Feb;16(1):60-73. 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

• Jun JE
• Hwang YC
• Ahn KJ
• Chung HY
• Choung SY
• Jeong IK

• KMID: 2525513
• DOI: http://doi.org/10.4162/nrp.2022.16.1.60

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.

Keyword

Metabolic syndrome; glucose; hypertension; functional food

Figure

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  Fig. 1 Selection of study subjects.

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  Fig. 2 Percent changes in HbA1c level between baseline and week 12 according to prediabetic and normal glycemic status. Data was presented as mean with standard deviation. The black bar represents the prediabetic group (n = 46), while the white bar represents the normal group (n = 28).HbA1c, hemoglobin A1c.*P-value < 0.05 for group comparison.

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  Fig. 3 Changes in prevalence and incidence of MetS between baseline and week 12. (A) Changes in placebo group. (B) Changes in D. morbifera group. Data was presented as percentage. The black bar represents the subjects with MetS, and the white bar represents those without. Thick solid red line represents the proportion of the subjects who do not have MetS at baseline, but developed new onset MetS at week 12. Thick solid blackline represents the proportion of the subjects who do not have MetS at baseline and week 12. Thick solid blue line represents the proportion of the subjects who had MetS at baseline, but recovered at week 12. Thick dotted black line represents the proportion of the subjects who had MetS at baseline and week 12.MetS, metabolic syndrome.*P < 0.05 for comparing the difference between D. morbifera and placebo group.

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