PMID- 35116128 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220430 IS - 1976-1457 (Print) IS - 2005-6168 (Electronic) IS - 1976-1457 (Linking) VI - 16 IP - 1 DP - 2022 Feb TI - The efficacy and safety of Dendropanax morbifera leaf extract on the metabolic syndrome: a 12-week, placebo controlled, double blind, and randomized controlled trial. PG - 60-73 LID - 10.4162/nrp.2022.16.1.60 [doi] AB - 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. CI - (c)2022 The Korean Nutrition Society and the Korean Society of Community Nutrition. FAU - Jun, Ji Eun AU - Jun JE AUID- ORCID: 0000-0002-7204-4913 AD - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea. FAU - Hwang, You-Cheol AU - Hwang YC AUID- ORCID: 0000-0003-4033-7874 AD - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea. FAU - Ahn, Kyu Jeung AU - Ahn KJ AUID- ORCID: 0000-0002-4648-3605 AD - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea. FAU - Chung, Ho Yeon AU - Chung HY AUID- ORCID: 0000-0002-4529-8280 AD - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea. FAU - Choung, Se Young AU - Choung SY AUID- ORCID: 0000-0001-7619-6263 AD - Department of Preventive Pharmacy and Toxicology, Department of Life and Nanopharmaceutical Sciences of Pharmacy, College of Pharmacy, Kyung Hee University, Seoul 02447, Korea. FAU - Jeong, In-Kyung AU - Jeong IK AUID- ORCID: 0000-0001-7857-546X AD - Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul 05278, Korea. LA - eng PT - Journal Article DEP - 20210629 PL - Korea (South) TA - Nutr Res Pract JT - Nutrition research and practice JID - 101311052 PMC - PMC8784258 OTO - NOTNLM OT - Metabolic syndrome OT - functional food OT - glucose OT - hypertension COIS- Conflict of Interest: The authors declare no potential conflicts of interests. EDAT- 2022/02/05 06:00 MHDA- 2022/02/05 06:01 PMCR- 2022/02/01 CRDT- 2022/02/04 05:48 PHST- 2021/01/21 00:00 [received] PHST- 2021/04/08 00:00 [revised] PHST- 2021/06/10 00:00 [accepted] PHST- 2022/02/04 05:48 [entrez] PHST- 2022/02/05 06:00 [pubmed] PHST- 2022/02/05 06:01 [medline] PHST- 2022/02/01 00:00 [pmc-release] AID - 10.4162/nrp.2022.16.1.60 [doi] PST - ppublish SO - Nutr Res Pract. 2022 Feb;16(1):60-73. doi: 10.4162/nrp.2022.16.1.60. Epub 2021 Jun 29.