UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Linking Setouchi Innate immune Network

Institute

Department

Personal name

Organization

Macrophi Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

10

Month

02

Day

Last modified on

2016

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022187