UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031550
Receipt number R000036023
Scientific Title Effects of consumption of juice containing anthocyanin on sensitivity to cold
Date of disclosure of the study information 2018/03/02
Last modified on 2018/09/03 10:43:38

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Basic information

Public title

Effects of consumption of juice containing anthocyanin on sensitivity to cold

Acronym

Effect of anthocyanin on sensitivity to cold

Scientific Title

Effects of consumption of juice containing anthocyanin on sensitivity to cold

Scientific Title:Acronym

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

1st name
Middle name
Last name Koichi Aizawa

Organization

Kagome CO.,LTD.

Division name

Innovation Division

Zip code


Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Email

Koichi_Aizawa@kagome.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Aizawa

Organization

Kagome CO.,LTD.

Division name

Innovation Division

Zip code


Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Homepage URL


Email

Koichi_Aizawa@kagome.co.jp


Sponsor or person

Institute

Kagome CO., LTD.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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 03 Month 02 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036023


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name