UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051004 |
|---|---|
| Receipt number | R000058059 |
| Scientific Title | Effect of Test Food Intake on Blood Flow and Intestinal Environment. |
| Date of disclosure of the study information | 2023/05/09 |
| Last modified on | 2024/05/07 14:44:00 |
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Basic information
Public title
Effect of Test Food Intake on Blood Flow and Intestinal Environment.
Acronym
Effect of Test Food Intake on Blood Flow and Intestinal Environment.
Scientific Title
Effect of Test Food Intake on Blood Flow and Intestinal Environment.
Scientific Title:Acronym
Effect of Test Food Intake on Blood Flow and Intestinal Environment.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of single and 4-week continuous intake of the test food on the blood flow and intestinal environment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes, amount of change, AUC, and recovery rate of blood flow-related indexes in cold water stress test (blood flow measurement with laser doppler, skin surface temperature measurement with thermography).
(Week0, Single dose, Week4 : before the cold stress test, just after the cold stress test, 2 min. after the cold stress test, 4 min. after the cold stress test, 6 min. after the cold stress test, 8 min. after the cold stress test, 10 min. after the cold stress test.)
Key secondary outcomes
*Secondary indexes
1) Capillary evaluation by capillary scope(1)
2) Ubjective questionnaire(1)
3) Blood hesperetin(1)
* Exploratory endpoint
1) Microbiome evaluation (genetic analysis [metagenomics]) (1)
2) Metabolite analysis (metabolomics) (1)
*Safety indexes
1) Blood pressure, pulsation. (1)
2) Weight,body fat percentage,BMI(1)
3) Hematologic test. (2)
4) Blood biochemical test. (2)
5) Urine analysis. (2)
6) Doctor's questions(1)
7) Adverse events: number of cases and expression rate of adverse events(3)
8) Subject's diary(4)
(1): Week0, Single dose, Week 4
(2): Week0, Week 4
(3): Single dose, Week 4
(4): From the first day of ingestion of a test material to the last day of the test
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (2 capsules in a day; 4 weeks / 2 capsules at single intake).
Interventions/Control_2
Oral intake of the placebo product (2 capsules in a day; 4 weeks / 2 capsules at single intake).
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 30-64 years.
2) Individuals who are healthy and have no chronic physical disease.
3) Individuals who are sensitive to cold.
4) Individuals whose written informed consent has been obtained.
5) Individuals who can come to the designated venue for this study and be inspected.
6) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
4) Individuals who are a patient or have a history of or endocrine disease.
5) Individuals with serious anemia.
6) Individuals who used a drug to treat a disease in the past 1 month.
7) Individuals whose BMI is less than 18.5kg/m2 and over 25kg/m2.
8) Individuals who have strong indefinite complaints due to menstruation and who may take medication to alleviate symptoms of anemia.
9) Individuals with constipation (less than 3 bowel movements per week, pain and bleeding during bowel movements, abdominal discomfort, etc.), and who may take medication to relieve constipation symptoms.
10) Individuals with inflammation and scratch at fingers.
11) Individuals who are a smoker.
12) Individuals who have excessive alcohol intake more than 20 g in a day of pure alcohol equivalent.
13) Individuals who have allergic reaction to ingredients of test foods and other foods or drugs.
14) Individuals with possible changes of life style during the test period.
15) Individuals who currently or within the past one month have a habit of continuously consuming citrus fruits (Unshu mikan, orange, lemon, navel, Iyokan, bitter orange, shikuwasa) and beverages or foods made from these fruits, or who plan to consume citrus fruits during the test period.
16) Individuals who have and had a habit to ingest food with functional claims, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
17) Individuals who are or are possibly, or are lactating.
18) Individuals who participated in other clinical studies in the past 3 months.
19) Individuals judged inappropriate for the trial by the principal.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nikken Foods 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058059
