Ulmus Macrocarpa Hance Extract and Lipid Profile

Dyslipidemias Clinical Trial

Official title:

Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773315
• Other study ID #: 02-2018-029
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2021
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 28, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Dietary Supplement:
• UMH extract
Schisandra chinensis extract 500 mg/day for 12 weeks
• Placebo
Starch placebo 500 mg/day for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Integrated Research Institute for Natural Ingredients and Functional Foods	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Sang Yeoup Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	LDL cholesterol	12 weeks
Secondary	Total cholesterol	Total cholesterol	12 weeks
Secondary	Triglyceride	Triglyceride	12 weeks
Secondary	HDL cholesterol	HDL cholesterol	12 weeks