UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023165 |
|---|---|
| Receipt number | 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 14:05:43 |
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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
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
mikity@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026706
