UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study examining the effects of continuous drink of olive tea on obesity and glucose metabolism : a randomized, parallel group, controlled trial.
Title of the study (Brief title)	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	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
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	Koichi Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Course of clinical research and regional innovation donated by the JA Ibaraki
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029615