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

Blood Flow Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03807570
• Other study ID #: BA-BF-MBE
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2020
• Source: Chonbuk National University Hospital
• Contact: Soo Wan Chae, Ph.D., M.D.
• Phone: 82-63-259-3040
• Email: soowan[@]jbnu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Flow

Intervention

Dietary Supplement:
• Morus Alba L. Extract
Morus Alba L. Extract 30 ml/day for 12 weeks.
• Placebo
Placebo 30 ml/day for 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Reactive Hyperemia Index	Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).	12 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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