NCT03807570

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

January 15, 2019

Last Update Submit

May 7, 2020

Conditions

Blood Flow

Keywords

Morus Alba L. ExtractClinical Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Changes of blood flow indices: PAI-1, t-PA

    12 weeks

  • Changes of Pulse wave

    12 weeks

  • Changes of Oxidation stress index: Oxidized LDL

    12 weeks

  • Changes of Lipid peroxidation index: MDA (Malondialdehyde)

    12 weeks

  • Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Morus Alba L. extract

EXPERIMENTAL

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

Dietary Supplement: Morus Alba L. Extract

Placebo

PLACEBO COMPARATOR

Placebo 30 ml/day for 12 weeks

Dietary Supplement: Placebo

Interventions

Morus Alba L. ExtractDIETARY_SUPPLEMENT

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

Morus Alba L. extract
PlaceboDIETARY_SUPPLEMENT

Placebo 30 ml/day for 12 weeks.

Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

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

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

January 15, 2019

First Posted

January 17, 2019

Study Start

November 12, 2018

Primary Completion

January 30, 2021

Study Completion

January 31, 2021

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

KR(1)