Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow

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

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

Study Overview

• Status: Unknown
• Conditions: Blood Flow
• Intervention / Treatment: Dietary supplement: Morus Alba L. Extract; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Morus Alba L. extract; Morus Alba L. extract 30 ml/day for 12 weeks	Dietary supplement: Morus Alba L. Extract; Morus Alba L. Extract 30 ml/day for 12 weeks.
PLACEBO_COMPARATOR: Placebo; Placebo 30 ml/day for 12 weeks	Dietary supplement: Placebo; Placebo 30 ml/day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Reactive Hyperemia Index	Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).	12 weeks
Changes of Platelet function assay	The whole blood with anticoagulant (sodium citrate) is passed through the capillary and the membrane to assess the degree of platelet adhesion to this membrane and the degree of occlusion of the capillary.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of blood flow indices: PAI-1, t-PA	Blood flow indices(PAI-1, t-PA) were measured in study visit 1(0 week) and visit 3(12 weeks).	12 weeks
Changes of Pulse wave	Measured using a pulse wave measuring device (uBioClipTM; BiosenseCreative Co., Ltd., Seoul, Korea) and measured three times, the average value of the measured values is indicated.	12 weeks
Changes of Oxidation stress index: Oxidized LDL	Oxidation stress indices(Oxidized LDL) was measured in study visit 1(0 week) and visit 3(12 weeks).	12 weeks
Changes of Lipid peroxidation index: MDA (Malondialdehyde)	Lipid peroxidation index{MDA(Malondialdehyde)} was measured in study visit 1(0 week) and visit 3(12 weeks).	12 weeks
Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C	Lipid metabolism indices(Total cholesterol, Triglyceride, LDL-C, HDL-C) were measured in study screening and visit 3(12 weeks).	12 weeks
Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C	It is calculated by the calculation formula using the lipid metabolism indicator test item.	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2018
• Primary Completion (ANTICIPATED): January 30, 2021
• Study Completion (ANTICIPATED): January 31, 2021

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (ACTUAL): January 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Clinical Trial; Morus Alba L. Extract
• Other Study ID Numbers: BA-BF-MBE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No