UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shinichiro Miyake, Takeru Nakamoto
Organization	Miyake Medical Institute Group
Division name	medical office
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	Yuko Nakamoto
Organization	Linking Setouchi Innate immune Network
Division name	Secretariat
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000022187