Clinical trial NCT03807570: Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Flow
Keywords: Morus Alba L. Extract
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related indicators is assessed compared to placebo intake.

Detailed description: This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was collected and changes in blood circulation related indicators were observed.

Eligibility criteria: Inclusion Criteria:

* Those with a fasting total cholesterol of 200\~239 mg/dL
* Those with a fasting LDL-cholesterol of 130\~159 mg/dL
* Those with a fasting blood sugar of 100\~125 mg/dL
* Those with a SBP of 120\~139 mmHg
* Those with a BMI of 25\~29.9 kg/m\^2
* Waist Hip Ratio (WHR) is 0.9 or more for males and 0.85 or more for females

Exclusion Criteria:

* Those with platelet aggregation and significant disability

  * The platelet count is less than 100,000/μL or more than 500,000/μL
  * The Hematocrit is less than 25%
* BMI is less than 18.5kg/m\^2 or greater than 30kg/m\^2
* Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Those with a history of clinically significant hypersensitivity to mulberry
* Those who have been taking platelet function, blood circulation improvement and hyperlipidemia related medicines, health functional food or herbal medicine continuously for more than 7 days within one month before screening
* Those who have received antipsychotic medication within 2 months before screening
* Those who participated in other clinical trials within 3 months before screening
* Women receiving hormone replacement therapy
* Laboratory test by show the following results

  * AST, ALT \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.

Primary outcomes:
measure: Changes of Reactive Hyperemia Index
timeFrame: 12 weeks
measure: Changes of Platelet function assay
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of blood flow indices: PAI-1, t-PA
timeFrame: 12 weeks
measure: Changes of Pulse wave
timeFrame: 12 weeks
measure: Changes of Oxidation stress index: Oxidized LDL
timeFrame: 12 weeks
measure: Changes of Lipid peroxidation index: MDA (Malondialdehyde)
timeFrame: 12 weeks
measure: Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C
timeFrame: 12 weeks
measure: Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References: