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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023165
Receipt No. R000026706
Scientific Title The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Date of disclosure of the study information 2016/09/01
Last modified on 2017/04/11

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Basic information
Public title The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Acronym The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Scientific Title The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Scientific Title:Acronym The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will examine the impact on lipid metabolism of the Water convolvulus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The test verifies the change over time in the total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol, body weight, body fat and Body Mass Index. (Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)
Key secondary outcomes The test verifies the change in the serum adiponectin and other biochemical indicators.(Before intake, after intake 4weeks, after intake 8weeks and after intake 12weeks.)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects takes the 12-week test food. The evaluation is carried out every four weeks.
Interventions/Control_2
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Japanese men and women from 20 years old to 80 years old
2.Those who fully understand and document agreed by free will of the subject person was obtained after having received a sufficient explanation of the study
3.Below, corresponding to either subjects
*LDL cholesterol level is borderline and person of mild range (120-159mg/dl)
*Who triglyceride levels of the high-normal range, and slightly higher (120-199mg/dl)
Key exclusion criteria 1.Those who are routinely regular use "Water convolvulus"
2.Excessive smoking and alcohol addicts as well as the diet is extremely irregular person
3.Those of serious diseases currently in treatment
4.Diabetes, liver disease, kidney disease, who underlying disease, such as heart disease that need is urgent treatment in serious condition
5.Those with a history of food allergies
6.A person with a plan of pregnancy during the lactation period and the person or test period during pregnancy
7.A person who has been determined to be inappropriate as a subject in the results of the screening
8. Other, who investigators were ineligible
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Ohno
Organization Osaka University Graduate School of Medicine
Division name Department of Integrative Medicine
Zip code
Address 2-2, Yamadaoka, Suita, OSAKA
TEL 06-6879-3498
Email ohno@cam.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miki Sakaue
Organization Osaka University Graduate School of Medicine
Division name Department of Integrative Medicine
Zip code
Address 2-2, Yamadaoka, Suita, OSAKA
TEL 06-6879-3498
Homepage URL
Email mikity@cam.med.osaka-u.ac.jp

Sponsor
Institute Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Okinawa TLO Ltd.
Organization
Division
Category of Funding Organization Other
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
2016 Year 09 Month 01 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
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 08 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
2016 Year 07 Month 14 Day
Last modified on
2017 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026706

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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