Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ulmus Macrocarpa Hance Extract and Lipid Profile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773315
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Dietary Supplement: UMH extract Dietary Supplement: Placebo Not Applicable

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;

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : February 14, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UMH group
This group takes UMH extract for 12 weeks
Dietary Supplement: UMH extract
Schisandra chinensis extract 500 mg/day for 12 weeks

Placebo Comparator: Placebo group
This group takes placebo for 12 weeks
Dietary Supplement: Placebo
Starch placebo 500 mg/day for 12 weeks




Primary Outcome Measures :
  1. LDL cholesterol [ Time Frame: 12 weeks ]
    LDL cholesterol


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: 12 weeks ]
    Total cholesterol

  2. Triglyceride [ Time Frame: 12 weeks ]
    Triglyceride

  3. HDL cholesterol [ Time Frame: 12 weeks ]
    HDL cholesterol



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773315


Locations
Layout table for location information
Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, Korea, Republic of, 50612
Sponsors and Collaborators
Sang Yeoup Lee
Investigators
Layout table for investigator information
Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
Layout table for additonal information
Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03773315    
Other Study ID Numbers: 02-2018-029
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases