UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058298 |
|---|---|
| Receipt number | R000066500 |
| Scientific Title | Effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/13 16:49:01 |
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Basic information
Public title
Effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels
Acronym
Effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels
Scientific Title
Effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels
Scientific Title:Acronym
Effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of daily ingestion of the dietary ingredient on cold sensitivity, blood flow, and blood vessels in healthy males and females aged 20 to under 65 years who are aware of their sensitivity to cold.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cold sensitivity
Key secondary outcomes
(Secondary outcomes)
Vascular endothelial function (flow-mediated vasodilation), questionnaire on eye and nasal symptoms (Japanese Allergic Conjunctival Disease Standard Quality of Life Questionnaire), blood fatty acid concentrations, blood lipid levels, blood metabolites, genomic information on single nucleotide polymorphisms (SNPs)
(Safety evaluation)
Vital signs, physical measurements (body weight and BMI), blood biochemical examination, hematologic test, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Daily ingestion of the test food 1 for 12 weeks
Interventions/Control_2
Daily ingestion of the test food 2 for 12 weeks
Interventions/Control_3
Daily ingestion of the placebo food for 12 weeks
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
Male and Female
Key inclusion criteria
1.Japanese males and females who are aged 20 to under 65 years at the time of written informed consent.
2.Subjects whose BMI is less than 30 kg/m2.
3.Subjects who are aware of their sensitivity to cold.
4.Non-smokers.
5.Subjects whose mean alcohol consumption of less than 30 g per day (as an average of one week).
6.Subjects who have been fully informed the purpose and details of the study, have the ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects receiving medication or outpatient treatment for a serious disease.
2.Subjects receiving exercise or diet therapy under the supervision of a physician.
3.Subjects who maybe for allergic reactions to the material of the test food (dietary ingredients).
4.Subjects with current or previous history of drug dependence or alcohol dependence.
5.Subjects who are currently seeing a doctor for the treatment of a psychiatric disorder (e.g., depression) and/or sleep disorder (e.g., insomnia, sleep apnea syndrome) or have previous history of a psychiatric disorder.
6.Subjects with a large wound or inflammation at the site of measurement (hand or arm) that may interfere with device measurement or evaluation
7.Subjects with excessively thick body hair or a tattoo at the site of measurement (hand or arm) that may interfere with device measurement or evaluation.
8.Subjects with symptoms of photosensitivity, ultraviolet allergy, or related conditions.
9.Night or shift workers with extremely irregular life patterns.
10.Subjects doing physical work for 10 hours or more per week.
11.Subjects whose eating, sleeping, and other habits are extremely irregular.
12.Subjects who are having a very unbalanced diet.
13.Subjects doing exercise to maintain or improve strength for 30 minutes or more twice a week.
14.Subjects whose body weight increased or decreased by 5 kg or more in the last 2 months.
15.Subjects with current or previous history of a brain disease, malignancy, immunological disease, diabetes mellitus, hepatic disease (hepatitis), renal disease, cardiac disease, thyroid disease, adrenal disease, metabolic disease, or other serious diseases.
16.Subjects who routinely consume health foods, supplements, and medications that affect vascular function.
17.Subjects who take products that impact antioxidant capacity such as health foods, supplements, and drugs (e.g., vitamins E and C, astaxanthin, beta-carotene, sesamin) three or more days a week.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
The Nisshin OilliO Group, 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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 27 | 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
| 2025 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
18.Subjects who take edible oils intended to maintain and improve health (e.g., MCT, flaxseed oil, perilla oil, EPA, DHA, olive oil) three or more days a week.
19.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
20.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
21.Female who are currently pregnant or breastfeeding, or may become pregnant or start breastfeeding during the study period.
22.Subjects who have difficulty complying with recording of each survey form.
23.Subjects whose laboratory test values or measurements at screening indicate their ineligibility to participate in the study.
24.Other Subjects who are considered ineligible for participation in the study by the investigator.
Management information
Registered date
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066500
