Ulmus Macrocarpa Hance Extract and Lipid Profile
Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedApril 28, 2021
April 1, 2021
1.2 years
December 10, 2018
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
LDL cholesterol
LDL cholesterol
12 weeks
Secondary Outcomes (3)
Total cholesterol
12 weeks
Triglyceride
12 weeks
HDL cholesterol
12 weeks
Study Arms (2)
UMH group
EXPERIMENTALThis group takes UMH extract for 12 weeks
Placebo group
PLACEBO COMPARATORThis group takes placebo for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- LDL cholesterol ranging from 130 to 190 mg/dL
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sang Yeoup Leelead
Study Sites (1)
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, 50612, South Korea
Related Publications (1)
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.
PMID: 36388925DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 12, 2018
Study Start
December 1, 2018
Primary Completion
February 14, 2020
Study Completion
February 28, 2020
Last Updated
April 28, 2021
Record last verified: 2021-04