UMIN-CTR Clinical Trial

Basic information
Public title	Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study.
Acronym	Clinical trial to investigate the effect of blueberry leaf extract on VFA reduction.
Scientific Title	Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study.
Scientific Title:Acronym	Clinical trial to investigate the effect of blueberry leaf extract on VFA reduction.
Region	Japan

Condition
Condition	Adults whose BMI is >= 23 kg/ m2 ,<30 kg/m2
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of blueberry leaf extract on VFA reduction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	VFA at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food.
Key secondary outcomes	1.Waist circumference 2.BMI, Body weight 3.The actual values and the change from pre-ingestion of glycolipid metabolism related index at each evaluation point (Adiponectin, Triglyceride, HDL-C, LDL-C, insulin, glucose). 4.The amount of activity (Step count, amount of exercise(EX)) 5. The actual values and the change from pre-ingestion of blood index at each evaluation point except 3. 6.Adverse events (They are assessed at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food except adverse events.)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects take test food (including blueberry extract) 3 tablets once day for 12 weeks.
Interventions/Control_2	The subjects take placebo food (not including blueberry extract) 3 tablets once day for 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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects whose BMI is >= 23 kg/ m2 ,<30 kg/m2 2. Subjects who have no abnormality in clinical problems by screening tests. 3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria	1. Subjects who have serious respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases. 2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study. 3. Pre- or post-menopausal women having obvious changes in physical condition. 4. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction. 5. Heavy drinkers (drink more than 80 g of alcohol per day), subjects who are dependent on alcohol or drugs, possible alcohol or drug abusers. 6. Subjects who regularly take drugs (anti-dyslipidemia,anti-diabetes etc.), which would affect this study. 7. Subjects who regularly take foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study. 8. Subjects who donate either 400 ml whole blood within, 200 ml whole blood or blood components within 4 weeks prior to this study. 9. Pregnant or lactating women or women expect to be pregnant during this study. 10. Subjects who have cognitive disorder or who have possibility of the disorder. 11. Subjects who participate and take the study drug in other clinical trials within 4 weeks prior to this study. 12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yasuji Middle name Last name Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, university of Miyazaki hospital
Zip code	889-1692
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Yasuji Middle name Last name Arimura
Organization	University of Miyazaki
Division name	Clinical research support center, university of Miyazaki hospital
Zip code	889-1692
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL	0985-85-9577
Homepage URL
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

Funding Source
Organization	Miyazaki Prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of University of Miyazaki
Address	Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel	0985-85-9010
Email	igakubu_kenkyu@med.miyazaki-u.ac.jp

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	2018 Year 06 Month 21 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	2018 Year 06 Month 14 Day
Date of IRB	2018 Year 06 Month 29 Day
Anticipated trial start date	2018 Year 07 Month 27 Day
Last follow-up date	2019 Year 01 Month 22 Day
Date of closure to data entry	2019 Year 09 Month 10 Day
Date trial data considered complete	2019 Year 09 Month 11 Day
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 20 Day
Last modified on	2020 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037708