UMIN-CTR Clinical Trial

Basic information
Public title	A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Acronym	A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Scientific Title	A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Scientific Title:Acronym	A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin surface temperature
Key secondary outcomes	Peripheral blood flow

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of a anthocyanin medium- containing juice (1 time) - washout period of week - Oral intake of a placebo juice (1 time) - washout period of week - Oral intake of a anthocyanin high - containing juice (1 time)
Interventions/Control_2	Oral intake of a anthocyanin high - containing juice (1 time) - washout period of week - Oral intake of a anthocyanin medium- containing juice (1 time) - washout period of week - Oral intake of a placebo juice (1 time)
Interventions/Control_3	Oral intake of a placebo juice (1 time) - washout period of week - Oral intake of a anthocyanin high- containing juice (1 time) - washout period of week - Oral intake of a anthocyanin medium - containing juice (1 time)
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
Key inclusion criteria	(1) Healthy males more than 20 years old. (2) Subjects who are sensitive to the cold and whose cold diagnosis questionnaire score is more than 4 points. (3) Subjects whose recovery rate of skin temperature is less than 90% after 10 minutes of cold loading. (4) Subjects who are obtained consent by document in free will.
Key exclusion criteria	(1)Subjects who have an allergy in connection with this study. (2) Subjects who have been diagnosed disease with vascular disorder (e.g., arteriosclerosis obliterans, obliterating arteritis, connective tissue disease, diabetes ). (3) Subjects who are judged as unsuitable for the study based on the results of medical questionnaire. (4) Subjects who have smoking habit. (5) Subjects who are regularly taking medicine (e.g., warfarin) which may influence skin surface temperature and blood flow. (6) Subjects who are taking health food, food for specified health use which may influence skin surface temperature and blood flow more than 3 times per week (e.g., functional food which assume polyphenol derived from ginger or hesperidin as active ingredient) . (7) Subjects who have taken anthocyanin enriched food more than 3 times per week. (8) Subjects who are judged as unsuitable for the study based on the results of clinical examination and cardiopulmonary function. (9) Subjects who have regular medication and a history of serious disease which needed medication treatment. (10)Subjects who are judged as unsuitable for the study based on the results of physical and clinical examination on before intake. (11)Subjects who have participated in other clinical study at the start of this study. (12)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Aizawa
Organization	Kagome Co.,Ltd
Division name	Innovation Division
Zip code	329-2762
Address	17,nishitomiyama,nasushiobara-shi,Tochigi
TEL	0287-36-2935
Email	Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person	1st name Kunihiko Middle name Last name Wasaki
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	0354593714
Homepage URL
Email	k.wasaki@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Kagome Co.,Ltd.
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	Kensho-kai Institutional Review Board
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka
Tel	06-6882-1130
Email	ethics_board@drc-web.co.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 09 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	2018 Year 09 Month 07 Day
Date of IRB	2018 Year 09 Month 07 Day
Anticipated trial start date	2018 Year 09 Month 21 Day
Last follow-up date	2018 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2020 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038972