UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044542 |
|---|---|
| Receipt number | R000050888 |
| Scientific Title | A confirmation study of test food in blood flow and body temperature |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2023/10/24 15:11:39 |
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Basic information
Public title
A confirmation study of test food in blood flow and body temperature
Acronym
A confirmation study of test food in blood flow and body temperature
Scientific Title
A confirmation study of test food in blood flow and body temperature
Scientific Title:Acronym
A confirmation study of test food in blood flow and body temperature
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify ingestion of test food on blood flow (skin blood flow) and body temperature (skin surface temperature).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow
(skin blood flow)
Body surface temperature (skin surface temperature)
Key secondary outcomes
VAS 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
Single ingestion of test food- washout period- single ingestion of placebo food.
Interventions/Control_2
Single ingestion of placebo food- washout period- single ingestion of test food.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy male/female subjects ranging in age from 20 to 60, at informed consent.
(2)Those who feel coldness in their hands and feet on a daily basis.
(3)Subjects whose BMI is less than 18.5 or over 30.0 kg/m^2.
(4)Subjects who can give informed consent to take part in this trial, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1)Subjects who had or suspected infectious disease such as COVID-19, or who had close contact with a COVID-19 patient.
(2)Subjects who have current medical treatments, or who are planning some kind of treatment the study period.
(3)Subjects who constantly use medicines that may affect test results.(cephem antibiotics such as Cefaclor, Cefotiam, Cefdinir, Anti-alcoholic drugs such as Disulfiram, Cyanamide etc.).Those who take health foods and supplements (turmeric, ornithine, etc.) daily, and those who may take or take them during the test period.
(4)Subjects who have wound or inflammation around the measurement area.
(5)Smokers or subjects who smoked within a year.
(6)Subjects who cannot intake the foods containing cacao (because of preference, headache, etc.)
(7)Subjects who are aware of the severity such as menstrual irregularity, menstrual pain, menopause.
(8)Subjects who have irregular eating habits or irregular life rhythm (shift worker, midnight worker).
(9)Pregnant, possibly pregnant, lactating women.
(10)Subjects who have current medical history or past medical history of high blood pressure.
(11)Subjects with previous/current medical history of serious disease in heart, liver, kidney, digestive organ etc.
(12)Subjects with excessive alcohol intakes.
(13)Subjects having drug/food allergy. (especially milk, soy, pork)
(14)Subjects who cannot remove their manicure or false nail on test-day.
(15)Subjects who are now under the other clinical trials with some kind of medicine/food, or participated in those within 4 weeks prior to this study, or are planning to join those after giving informed consent to take part in this study.
(16)Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinion.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kawama |
Organization
Morinaga & Co.,Ltd
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
t-kawama-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inagaki |
Organization
Morinaga & Co.,Ltd
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
070-3864-8665
Homepage URL
h-inagaki-jj@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
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
チヨダパラメディカルケアクリニック/Chiyoda Paramedical Care Clinic
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Jpn Pharmacol Ther vol.49, no.10, 1697-1704 2021
Publication of results
Published
Result
URL related to results and publications
Jpn Pharmacol Ther vol.49, no.10, 1697-1704 2021
Number of participants that the trial has enrolled
27
Results
Test food intake significantly increased skin blood flow, and skin surface temperature compared to control food. The VAS analysis showed a significant improvement in "hand coldness" 60 minutes after test food intake compared to control food.
Results date posted
| 2021 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Jpn Pharmacol Ther vol.49, no.10, 1697-1704 2021
Participant flow
Jpn Pharmacol Ther vol.49, no.10, 1697-1704 2021
Adverse events
None
Outcome measures
Blood flow (skin blood flow)
Body surface temperature (skin surface temperature)
VAS questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050888
