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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019210
Receipt No. R000022187
Scientific Title Effect of 3 months continuous intake of LPS-supplement on the maintenance of healthy blood vessels and blood flow in 65 years old from 20 years old : parallel double-blind randomized controlled study.
Date of disclosure of the study information 2015/10/02
Last modified on 2016/04/04

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Basic information
Public title Effect of 3 months continuous intake of LPS-supplement on the maintenance of healthy blood vessels and blood flow in 65 years old from 20 years old : parallel double-blind randomized controlled study.
Acronym Double-blind study about the effectiveness of LPS-supplement on the maintenance of healthy blood vessels and blood flow.
Scientific Title Effect of 3 months continuous intake of LPS-supplement on the maintenance of healthy blood vessels and blood flow in 65 years old from 20 years old : parallel double-blind randomized controlled study.
Scientific Title:Acronym Double-blind study about the effectiveness of LPS-supplement on the maintenance of healthy blood vessels and blood flow.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the effectiveness of 3 months continuous intake of LPS-supplement on the maintenance of healthy blood vessels and blood flow in person aged 20 to 65 years old.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood test (oxidized LDL, LDL, HDL, triglyceride)
Key secondary outcomes Blood test (WBC, RBC, HbA1c, AST (GOT), ALT (GPT), creatinine, CRP, IgA)
Physical examination (body weight, body fat, arteriosclerosis examination, blood flow measurement)
Questionnaire (neck stiffness, feeling of coldness, feeling of hotness, bowel movement, sleep, common cold)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of the test-supplement for 3 months
Interventions/Control_2 Intake of the placebo for 3 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Who can understand the contents of the study and can consent to the participation to the study after receiving the explanation.
2) Persons older than 20 years and younger than 74 years at the date of consent whose blood test values at the time of screening are in range shown in the point.
LDL (mg/dL)60-139, HDL(mg/dL):40-119, triglyceride(mg/dL):30-199, WBC(times1,000/microliter):3.2-8.9, RBC(times10,000/microliter):male 400-599,female:360-549, AST(GOT):(U/L)0-35, ALT(GPT) (U/L):0-40, creatinine(mg/dL):male:under 1.09 female:under 0.79, HbA1c(parcent):under 5.9
Key exclusion criteria 1) Whose blood markers levels examined at the time of screening are not normal.
2) Who is using drug or food that principle-investigator or sub-investigator judged to affect the result of the study.
3) Who are participating or are planning to participate to other interventional study.
4) Who have donated blood more than 400mL within the last three months or more than 200mL within the last one month before the date of consent.
5) Who is judged to be unsuitable for this study by principle-investigator or sub-investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Miyake, Takeru Nakamoto
Organization Miyake Medical Institute Group
Division name medical office
Zip code
Address 1-10-16,Ban-cho,Takamatsu-shi,Kagawa-ken
TEL 087-831-2101
Email takeruna@miyake.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Nakamoto
Organization Linking Setouchi Innate immune Network
Division name Secretariat
Zip code
Address 3rd floor,2217-16,Hayashi-cho,Takamatsu-shi,Kagawa-ken
TEL 087-813-9201
Homepage URL
Email npolsinlsin@lsin.org

Sponsor
Institute Linking Setouchi Innate immune Network
Institute
Department

Funding Source
Organization Macrophi Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 02 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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