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

NCT ID: NCT03807570

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Flow

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Morus Alba L. extract

Morus Alba L. extract 30 ml/day for 12 weeks

Group Type EXPERIMENTAL

Morus Alba L. Extract

Intervention Type DIETARY_SUPPLEMENT

Morus Alba L. Extract 30 ml/day for 12 weeks.

Placebo

Placebo 30 ml/day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 30 ml/day for 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Morus Alba L. Extract

Morus Alba L. Extract 30 ml/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 30 ml/day for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Soo Wan Chae, Ph.D., M.D.

Role: CONTACT

82-63-259-3040

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BA-BF-MBE

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Palmitic Acid and Human Microvascular Function
NCT06683534 NOT_YET_RECRUITING PHASE2