UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056919 |
|---|---|
| Receipt number | R000064980 |
| Scientific Title | Study of the effects on blood biochemical data after ingestion of foods |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/01/29 17:13:48 |
* 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 of the effects on blood biochemical data after ingestion of foods
Acronym
Study of the effects on blood biochemical data after ingestion of foods
Scientific Title
Study of the effects on blood biochemical data after ingestion of foods
Scientific Title:Acronym
Study of the effects on blood biochemical data after ingestion of foods
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect on blood biochemical data after ingestion of foods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood Analysis and Questionnaire
Key secondary outcomes
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
Oral ingestion of the test food
Interventions/Control_2
Oral ingestion of the placebo 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
Key inclusion criteria
1 Japanese males who are between 20 and 60 years of age at the time of obtaining consent
2 Participants who are able to come to the clinic on the designated date and have multiple blood samples taken (7 samples/day x 2 observations)
3 Healthy participants* *"Healthy" in this study refers to those who have no serious organ damage or disease and are not receiving any treatment related to them or any kind of drug therapy. Whether or not a participant is "healthy" is based on the participant's report at the start of the study.
4 Participants who have been fully informed of the purpose and content of the study, have the capacity to consent, understands the study, voluntarily volunteers to participate in the study, and are able to give written consent to participate in the study.
5 Participants with a BMI 20 to 24.9 (male)
Key exclusion criteria
Participants
1 with chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidney, urinary system, mental, nervous system, or blood system
2 who are allergic to medicines or food.
3 who have a smoking habit.
4 who may change their lifestyle during the study period (e.g., work at night, travel for long periods, etc.)
5 who are going to the hospital, taking medication, or undergoing medical treatment
6 with lifestyle-related diseases (diabetes, hypertension, dyslipidemia, etc.) such as those whose fasting blood glucose level is in the diabetic range (fasting blood glucose of 126 mg/dL or higher) or those who have been diagnosed in the past
7 with severe anemia
8 who dislike chocolate.
9 who have a habit of taking drugs for the purpose of disease treatment in the past month (excluding those who have taken drugs for headache, menstrual cramps, common cold, etc.).
10 who have received treatment involving hospitalization within the past 6 months.
11 who are aliquor heavy drinkers (more than 60g of alcohol per day e.g., 1500ml of beer, 2.5 g of sake, approximately 200ml of whiskey straight)
12 who are currently participating in another clinical trial, will participate in another clinical trial within 4 weeks after the completion of the trial, or will participate in another clinical trial after agreeing to participate in the said trial.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Kinta |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
y-kinta-if@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Uchida |
Organization
Morinaga & Co., Ltd.
Division name
R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
h-uchida-ji@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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
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 | 07 | Month | 01 | 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 | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064980
