UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of intake of Okinawa ingredients (Water convolvulus) on lipid metabolism
Title of the study (Brief title)	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	Satoshi Ohno
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	2-2, Yamadaoka, Suita, OSAKA
TEL	06-6879-3498
Email	ohno@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Miki Sakaue
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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