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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034184
Receipt No. R000038972
Scientific Title A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Date of disclosure of the study information 2018/09/20
Last modified on 2018/09/18

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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
Middle name
Last name Koichi Aizawa
Organization Kagome Co.,Ltd
Division name Innovation Division
Zip code
Address 17,nishitomiyama,nasushiobara-shi,Tochigi
TEL 0287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiko Wasaki
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL 03-5459-5329
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
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 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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 21 Day
Last follow-up date
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
2018 Year 09 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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