UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027328 |
|---|---|
| Receipt number | 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 18:06:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yoshida_keishirou@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031124
