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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025741
Receipt No. 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

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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
Email 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
Email koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
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

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029615

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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