UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Acronym	Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Scientific Title	Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Scientific Title:Acronym	Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Preliminary evaluation of the effect on brown adipose tissue function of healthy adults before and after ingestion of fruit juice.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in resting energy expenditure and body temperature around brown adipose tissue after 4 weeks of ingestion
Key secondary outcomes	Changes in body composition Oxygen consumption

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	Healthy volunteers are given juice (100ml/day) every day for 4 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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy male and female over 20 years old
Key exclusion criteria	1) Subject who have some kind of illness and are being treated with drugs 2) Subjects who regularly use health foods such as supplements 3) Subjects with serious or allergic illness 4) Pregnant woman 5) Subjects who are judge as unsuitable for the study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Ippei Middle name Last name Shimizu
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Email	ippeishimizu@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Furuuchi
Organization	Bourbon corporation
Division name	Institutes of Health
Zip code	956-0841
Address	316-2 Higashijima, Akiha-ku, Niigata
TEL	0250-25-1296
Homepage URL
Email	furuuchi-ryo@bourbon.co.jp

Sponsor
Institute	Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Bourbon corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The ethical committees of Niigata University
Address	1-757 Asahimachidori, Chuo-ku, Niigata
Tel	025-227-2625
Email	ethics@adm.niigata-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	2021 Year 03 Month 05 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	10
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	2020 Year 11 Month 17 Day
Date of IRB	2021 Year 01 Month 04 Day
Anticipated trial start date	2021 Year 03 Month 05 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 01 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049594