UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025741 |
|---|---|
| Receipt number | R000029615 |
| Scientific Title | The study examining the effects of continuous drink of olive tea on obesity and glucose metabolism : a randomized, parallel group, controlled trial. |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2018/01/20 10:01:24 |
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Basic information
Public title
The study examining the effects of continuous drink of olive tea on obesity and glucose metabolism : a randomized, parallel group, controlled trial.
Acronym
Continuous drink study of olive tea
Scientific Title
The study examining the effects of continuous drink of olive tea on obesity and glucose metabolism : a randomized, parallel group, controlled trial.
Scientific Title:Acronym
Continuous drink study of olive tea
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the continuous drink of olive tea on obesity and glucose metabolism compared with low- concentrated olive tea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in body weight and abdominal circumference from baseline to 12 weeks.
Key secondary outcomes
Change in following items from baseline to 12 weeks
1) Glucose metabolic indicator
2) Dietary habit
3) Lipid metabolic indicator
4) Hepatic and renal function indicator
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Olive tea(12 weeks)
Interventions/Control_2
low-concentrated olive tea(12 weeks)
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Aged 40-64 years.
2) BMI not less than 25.0 kg/m2, under 30.0 kg/m2
3) FPG not less than 100 mg/dL, under 126 mg/dL and/or HbA1c not less than 5.7%, under 6.5%
4) Capable of giving informed consent
Key exclusion criteria
1) Subjects who are treated for diabetes.
2) Subjects who are received pharmacotherapy for dyslipidemia.
3) Subjects who are taking medications that affect weight fluctuation and glucose metabolism such as antidepressant.
4) Subjects who are habitually taking supplement (including "food for specified health use", and "foods with function claims") that affect weight fluctuation and glucose metabolism.
5) Subjects who are habitually drinking olive tea.
6) Subjects who had participated in intervention study using olive tea.
7) Subjects who succeeded in losing weight greater than or equal 5% in the past year.
8) Subjects who are treated for anemia or have treatment history for anemia.
9) Subjects who are enrollment in another interventional study
10) Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba, Faculty of Medicene
Division name
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
koichi.hashimoto@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hashimoto |
Organization
University of Tsukuba, Faculty of Medicene
Division name
Course of clinical research and regional innovation donated by the JA Ibaraki
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3064
Homepage URL
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba,Faculty of Medicine
Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Institute
Department
Personal name
Funding Source
Organization
Yamahisa Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1) Yamahisa Co.Ltd
2) University of Tsukuba, Faculty of Life and enviromental sciences
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 20 | 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
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 19 | Day |
Last modified on
| 2018 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029615
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
