Ulmus Macrocarpa Hance Extract and Lipid Profile

Not Applicable

Completed

• Conditions: Dyslipidemias
• Interventions: Dietary Supplement: UMH extract; Dietary Supplement: Placebo

• Registration Number: NCT03773315
• Lead Sponsor: Sang Yeoup Lee

Brief Summary

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with dyslipidemia for 12 weeks.

Detailed Description

Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• LDL cholesterol ranging from 130 to 190 mg/dL

Exclusion Criteria

• Abnormal liver or renal function (i.e., serum aminotransferase activity > 80 IU/L and serum creatinine concentrations > 1.2 mg/dL)
• Diabetes (diagnosed clinically or fasting glucose level > 126 mg/dL)
• History of ischemic heart disease or cerebrovascular disease
• Uncontrolled hypertension
• History of serious cardiac disease such as angina or myocardial infarction
• History of gastrectomy
• History of medication for psychiatric disease
• Administration of oriental medicine including herbs within the past 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UMH group	UMH extract	This group takes UMH extract for 12 weeks
Placebo group	Placebo	This group takes placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
LDL cholesterol	12 weeks	LDL cholesterol

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	12 weeks	Total cholesterol
Triglyceride	12 weeks	Triglyceride
HDL cholesterol	12 weeks	HDL cholesterol

Trial Locations

Locations (1)

Integrated Research Institute for Natural Ingredients and Functional Foods; 🇰🇷 Yangsan, Korea, Republic of