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Completed

NCT Number: NCT03773315

Ulmus Macrocarpa Hance Extract and Lipid Profile

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrated Research Institute for Natural Ingredients and Functional Foods

Yangsan, 50612, South Korea

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UMH extract

Dietary Supplement

Schisandra chinensis extract 500 mg/day for 12 weeks

Placebo

Dietary Supplement

Starch placebo 500 mg/day for 12 weeks

Primary outcomes

  1. LDL cholesterol

    Time frame: 12 weeks

    LDL cholesterol

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sang Yeoup Lee

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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