UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of consumption of juice containing anthocyanin on sensitivity to cold
Title of the study (Brief title)	Effect of anthocyanin on sensitivity to cold
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of intervention with juice containing anthocyanin consumption on sensitivity to cold
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin surface temperature following the exposure to cold water stress
Key secondary outcomes	Blood flow rate following the exposure to cold water stress

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is 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	Juice containing anthocyanin -> washout period -> Juice not containing anthocyanin -> washout period -> Mineral water
Interventions/Control_2	Juice not containing anthocyanin -> washout period -> Juice containing anthocyanin -> washout period-> Mineral water
Interventions/Control_3	Mineral water -> washout period -> Juice not containing anthocyanin -> washout period -> Juice containing anthocyanin
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	65 years-old >
Gender	Female
Key inclusion criteria	Healthy adult females with sensitivity to cold
Key exclusion criteria	1) Subjects who have alimentary allergy. 2) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period. 3) Subjects with vascular function disorder (arteriosclerosis obliterans, arteritis obliterans, connective tissue disease, diabetes mellitus) 4) Current smoker 5) Subjects who are judged unsuitable for this study by doctor because of participating in other reasons.
Target sample size	10

Research contact person
Name of lead principal investigator	Koichi Aizawa
Organization	Kagome CO.,LTD.
Division name	Innovation Division
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Email	Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person	Koichi Aizawa
Organization	Kagome CO.,LTD.
Division name	Innovation Division
Address	17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan
TEL	0287-36-2935
Homepage URL
Email	Koichi_Aizawa@kagome.co.jp

Sponsor
Institute	Kagome CO., LTD.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 03 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2018 Year 07 Month 30 Day
Date analysis concluded	2018 Year 07 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 02 Day
Last modified on	2018 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036023