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Ulmus Macrocarpa Hance Extract and Lipid Profile

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ClinicalTrials.gov Identifier: NCT03773315
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
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;

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

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



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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


Contacts
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Contact: Sang Yeoup Lee 360-1442 ext 055 saylee@pnu.edu
Contact: Ye Li Lee 360-2860 ext 055 yeri1230@gmail.com

Locations
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Korea, Republic of
Integrated Research Institute for Natural Ingredients and Functional Foods Recruiting
Yangsan, Korea, Republic of, 50612
Contact: Sang Yeoup Lee, MD    82-55-360-2860    saylee@pnu.edu   
Sponsors and Collaborators
Sang Yeoup Lee
Investigators
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Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital

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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03773315     History of Changes
Other Study ID Numbers: 02-2018-029
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases