UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055877 |
|---|---|
| Receipt number | R000063771 |
| Scientific Title | Analysis of changes in blood factors due to ingestion of test foods |
| Date of disclosure of the study information | 2024/10/20 |
| Last modified on | 2025/03/26 18:38:10 |
* 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
Analysis of changes in blood factors due to ingestion of test foods
Acronym
Analysis of changes in blood factors due to ingestion of test foods
Scientific Title
Analysis of changes in blood factors due to ingestion of test foods
Scientific Title:Acronym
Analysis of changes in blood factors due to ingestion of test foods
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 variation in blood miRNA levels after a single consumption of the food under study at each observation period and the blood miRNA levels after two consecutive weeks of consumption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
miRNA in blood(miRNA levels and their changes)
Observation period I and II
Key secondary outcomes
*Safety
1) Blood pressure, pulsation. (1)
2) Weight,body fat percentage,BMI. (1)
3) Doctor's questions/ Adverse events. (1)
4) Diary written while living. (2)
(1): Observation period I and II
(2): Written daily from observation period I to the day before observation period II
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
[1]Oral ingestion of a test food (10 tablets/single dose, 2 weeks).
[2]Observation.
[3]Washout (over 13days).
[4]Oral ingestion of a control food (10 tablets/2 weeks).
[5]Observation.
Interventions/Control_2
[1]Oral ingestion of a control food (10 tablets/single dose, 2 weeks).
[2]Observation.
[3]Washout (over 13days).
[4]Oral ingestion of a test food (10 tablets/2 weeks).
[5]Observation.
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1) Japanese males aged 20-64 years.
2) Individuals whose written informed consent has been obtained after explanation of this study.
Key exclusion criteria
1) Individuals who have taken drugs that could potentially affect the study for 1 month prior to the pre-test, or who cannot limit their use from the pre-test to the end of the study (except for a history of medication such as headache, common cold, etc.).
2) Individuals with a history or current history of mental illness, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness.
3) Individuals who have a history or current history of serious disorders of the liver, kidney, heart, lungs, blood, etc.
4) Individuals who are a patient or have a history of or endocrine disease.
5) Individuals with serious anemia.
6) Individuals whose BMI is less than 18.5kg/m2 and over 25.0kg/m2.
7) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
8) Individuals who have been taking functional foods, health foods, or supplements on a continuous basis at present or within the past month, and those who are planning to take them during the study period.
9) Individuals who experienced unpleasant feeling during blood drawing.
10) Individuals with drug and food allergies.
11) Smokers or those who have quit smoking for less than 6 months.
12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
13) Shift workers, late-night workers, and others with irregular life rhythms.
14) Individuals who participated in other clinical studies in the past 1 month.
15) Individuals judged inappropriate for the study by the principal.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Oki |
Organization
Seishukai Clinic
Division name
Head
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
+81-3-5830-5654
k-sudo@seishukai.or.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Sudo |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
+81-3-5830-5654
Homepage URL
k-sudo@seishukai.or.jp
Sponsor or person
Institute
Seishukai Clinic
Institute
Department
Personal name
Funding Source
Organization
Meiji Holdings 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
| 2024 | Year | 10 | Month | 20 | 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 | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 17 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063771
