UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054951 |
|---|---|
| Receipt number | R000062712 |
| Scientific Title | Study to verify the effects and safety of test food intake on vascular endothelial function and capillaries |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/12/26 10:28:04 |
* 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
Study to verify the effects and safety of test food intake on vascular endothelial function and capillaries
Acronym
Study to verify the effects and safety of test food intake on vascular endothelial function and capillaries
Scientific Title
Study to verify the effects and safety of test food intake on vascular endothelial function and capillaries
Scientific Title:Acronym
Study to verify the effects and safety of test food intake on vascular endothelial function and capillaries
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of the test food on vascular endothelial function and capillaries, and to verify the safety of the test food after 12 weeks of continuous consumption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FMD Measurement(Blood Flow Dependent Vasodilatory Response Test)
( Week 0, Week 12 )
Key secondary outcomes
* Secondary indexes
1) Capillary image analysis with capillaroscope (number, length, vessel width, turbidity and nail bed blood flow) (1)
2) Physical examination (Blood pressure, pulsation, Weight, Body fat percentage, BMI) (1)
3) Clinical examination (Hematologic test, Blood biochemical test, Urine analysis) (1)
4) Experience-based questionnaire survey (1)
* Safety
1) Doctor's questions / Determination of adverse events and side effects (1)
2) Subject's diary (2)
(1): Week 0, Week 6, Week 12
(2): 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 food (3 tablets in a day; 12 weeks).
Interventions/Control_2
Oral intake of the placebo food (3 tablets in a day; 12 weeks).
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and postmenopausal women who are between 40 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals who are healthy and have no chronic physical disease including skin disease.
3) Individuals whose written informed consent has been obtained.
4) Individuals who can come to the designated venue for this study and be inspected.
5) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals with a history or current history of mental illness, sleep disorders, menopausal disorders, hypertension, diabetes, dyslipidemia or serious illness
3) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung damage 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 over 30 kg/m2.
8) Individuals who may develop allergic symptoms to any ingredient in the tested food, or to any other food or drug.
9) Individuals who have been taking functional foods, health foods, supplements, etc. on a continuous basis at present or within the past 3 months, and those who are planning to take them during the study period.
10) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
11) Individuals who are a smoker.
12) Individuals who engage in a night work.
13) Individuals with possible changes of life style during the test period.
14) Individuals with inflammation or wounds on the fingers.
15) Individuals who have had more than 200 mL of blood drawn (e.g., blood donation) within 1 month of the start of this study or more than 400 mL within 3 months of the start of this study.
16) Individuals who participated in other clinical studies in the past 3 months.
17) Individuals who are or whose family is engaged in healthy or functional foods.
18) Individuals judged inappropriate for the study by the principal.
Target sample size
40
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
SANOH CORPORATION
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
| 2024 | Year | 07 | Month | 16 | 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
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062712
