Back to resultsUlmus Macrocarpa Hance Extract and Lipid Profile
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
UMH extract
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility 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
Sites / Locations
- Integrated Research Institute for Natural Ingredients and Functional Foods
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UMH group
Placebo group
Arm Description
This group takes UMH extract for 12 weeks
This group takes placebo for 12 weeks
Outcomes
Primary Outcome Measures
LDL cholesterol
LDL cholesterol
Secondary Outcome Measures
Total cholesterol
Total cholesterol
Triglyceride
Triglyceride
HDL cholesterol
HDL cholesterol
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03773315
Brief Title
Ulmus Macrocarpa Hance Extract and Lipid Profile
Official Title
Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sang Yeoup Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UMH group
Arm Type
Experimental
Arm Description
This group takes UMH extract for 12 weeks
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
UMH extract
Intervention Description
Schisandra chinensis extract 500 mg/day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Starch placebo 500 mg/day for 12 weeks
Primary Outcome Measure Information:
Title
LDL cholesterol
Description
LDL cholesterol
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Total cholesterol
Time Frame
12 weeks
Title
Triglyceride
Description
Triglyceride
Time Frame
12 weeks
Title
HDL cholesterol
Description
HDL cholesterol
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Research Institute for Natural Ingredients and Functional Foods
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
36388925
Citation
Lee YL, Lee SY. Potential lipid-lowering effects of Ulmus macrocarpa Hance extract in adults with untreated high low-density lipoprotein cholesterol concentrations: A randomized double-blind placebo-controlled trial. Front Med (Lausanne). 2022 Nov 1;9:1000428. doi: 10.3389/fmed.2022.1000428. eCollection 2022.
Results Reference
derived
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Ulmus Macrocarpa Hance Extract and Lipid Profile
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