Blood FlowNCT03807570
Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow
A study testing Morus Alba L. Extract in people with Blood Flow, run by Chonbuk National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow
- What is being tested?
- Morus Alba L. Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Nov 2018to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Soo-Wan Chae, MD., PhD, 82-63-259-3040, swchae@jbctc.org
About this study
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
The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related indicators is assessed compared to placebo intake.
Read the 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.
- Conditions
- Blood Flow
- Being tested
- Morus Alba L. Extract, Placebo
- Keywords
- Morus Alba L. Extract, Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morus Alba L. ExtractDietary supplement
Morus Alba L. Extract 30 ml/day for 12 weeks.
PlaceboDietary supplement
Placebo 30 ml/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Morus Alba L. extract | Experimental | Morus Alba L. extract 30 ml/day for 12 weeks Receives: Dietary Supplement: Morus Alba L. Extract |
| Placebo | Placebo comparator | Placebo 30 ml/day for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Reactive Hyperemia Index
Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).
Measured: 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.
Measured: 12 weeks
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start12 Nov 2018
- Primary completion30 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood FlowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807570
- Sponsor's protocol ID
- BA-BF-MBE
- Status last verified
- May 2020
- First submitted
- 15 Jan 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03807570
- Acronym / sponsor ID
- BA-BF-MBE
- Conditions
- Blood Flow
- Keywords
- Morus Alba L. Extract, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morus Alba L. extract | Experimental | Dietary Supplement: Morus Alba L. ExtractMorus Alba L. extract 30 ml/day for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 30 ml/day for 12 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Those with platelet aggregation and significant disability
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morus Alba L. ExtractMorus Alba L. Extract 30 ml/day for 12 weeks. | Dietary supplement | Morus Alba L. extract |
| PlaceboPlacebo 30 ml/day for 12 weeks. | Dietary supplement | Placebo |
Primary outcome
Changes of Reactive Hyperemia Index
Time frame: 12 weeks
Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).
Changes of Platelet function assay
Time frame: 12 weeks
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.
6 secondary outcomes
Changes of blood flow indices: PAI-1, t-PA
Time frame: 12 weeks
Changes of Pulse wave
Time frame: 12 weeks
Changes of Oxidation stress index: Oxidized LDL
Time frame: 12 weeks
Changes of Lipid peroxidation index: MDA (Malondialdehyde)
Time frame: 12 weeks
Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C
Time frame: 12 weeks
Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morus Alba L. Extract in people with Blood Flow, run by Chonbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Wan Chae, Ph.D., M.D. (82-63-259-3040, soowan@jbnu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Reactive Hyperemia Index (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.