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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027328
Receipt No. R000031124
Scientific Title A study for evaluating the effects of oral intake of food containing plants extract on cold sensitivity of periphery. A placebo-controlled, randomized, double-blind, cross-over trial.
Date of disclosure of the study information 2017/05/12
Last modified on 2017/05/12

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Basic information
Public title A study for evaluating the effects of oral intake of food containing plants extract on cold sensitivity of periphery. A placebo-controlled, randomized, double-blind, cross-over trial.
Acronym A study for evaluating the effects of oral intake of food containing plants extract on cold of periphery.
Scientific Title A study for evaluating the effects of oral intake of food containing plants extract on cold sensitivity of periphery. A placebo-controlled, randomized, double-blind, cross-over trial.
Scientific Title:Acronym A study for evaluating the effects of oral intake of food containing plants extract on cold of periphery.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of food with plants extract on skin surface temperature and blood flow following the exposure to cold water stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin surface temperature of fingertip following the exposure to cold water stress.
Blood flow of fingertip following the exposure to cold water stress.
Key secondary outcomes Feeling questionnaire.

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Test food with plants extract (single ingestion) - washout period - placebo food without plants extract (single ingestion)
Interventions/Control_2 Placebo food without plants extract (single ingestion) - washout period - test food with plants extract (single ingestion)
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
50 years-old >
Gender Female
Key inclusion criteria (1) Subjects who are sensitive to cold
(2) Females from 20 to 49 years of age
(3) Subjects giving written informed consent
Key exclusion criteria (1) Individuals who are under treatment or have a history of Cardiovascular disease (including cardiac infarct, arrhythmia, high-blood pressure, ischemic cardiac disease, aneurysm of aorta, dissection of the aorta, diabetes, renal failure, low-blood pressure etc. )
(2) Individuals who are currently suffering from some disease and undergoing drug treatment
(3) Individuals taking drugs (including aspirin and warfarin etc.), health foods and foods with function claims (including hesperidin and ginger etc.) in common use, which influence blood flow
(4) Shift worker at midnight and irregular time zones
(5) Individuals presenting known food allergy
(6) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(7) Individuals who are judged as unsuitable for the study by the investigator
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keishiro Yoshida
Organization Lotte Co., Ltd.
Division name Central Laboratory, Food material development section
Zip code
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0187
Email yoshida_keishirou@lotte.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keishiro Yoshida
Organization Lotte Co., Ltd.
Division name Central Laboratory, Food material development section
Zip code
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0187
Homepage URL
Email yoshida_keishirou@lotte.co.jp

Sponsor
Institute Lotte Co., Ltd.
Institute
Department

Funding Source
Organization Lotte 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
2017 Year 05 Month 12 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
2017 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 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
2017 Year 05 Month 12 Day
Last modified on
2017 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031124

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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