UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055872 |
|---|---|
| Receipt number | R000063592 |
| Scientific Title | Effects of single nucleotide polymorphisms (SNPs) on the functions of dietary ingredients |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2025/08/05 09:21:06 |
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Basic information
Public title
Effects of single nucleotide polymorphisms (SNPs) on the functions of dietary ingredients
Acronym
Effects of single nucleotide polymorphisms (SNPs) on the functions of dietary ingredients
Scientific Title
Effects of single nucleotide polymorphisms (SNPs) on the functions of dietary ingredients
Scientific Title:Acronym
Effects of single nucleotide polymorphisms (SNPs) on the functions of dietary ingredients
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 functional ingredients in food on humans and their relationship with human genomic information.
Basic objectives2
Others
Basic objectives -Others
Prevalence of SNPs associated with functions of functional ingredients in food in the Japanese population.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation between SNP-related genomic information and the effects of functional food intake during previous functional food study participation.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Among the subjects who participated in the following studies and ingested the test food, those who had a measured value to evaluate the correlation with the subject's SNP.
･NOR18-001:Effects of functional dietary ingredients on post-meal bodily sensation
･NOR19-001:Effect of continuous ingestion of dietary components on postprandial substrate metabolism under conditions without weight fluctuation
･NOR19-002:Effects of functional dietary ingredients on post-meal bodily sensation
･NOR20-001:Effect of continuous intake of dietary components on postprandial substrate metabolism under dietary maintenance conditions
･NOR20-002:Effects of continuous intake of dietary components on body composition and function under the condition of maintaining food intake
･NOR21-001:Effect of continuous ingestion of dietary components on risk factors for arteriosclerosis under body weight maintenance conditions
･NOR22-001:Effects of continuous ingestion of dietary ingredients on the skin and blood vessels
2.Subjects who are fully explained the purpose and details of the study, have 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 who are judged to have difficulty in saliva collection due to the following (1) to (4).
(1)Subjects receiving medication or outpatient treatment for a serious disease.
(2)Subjects with current or previous history of drug dependence or alcohol dependence.
(3)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.
(4)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.
2.Other Subjects who are considered ineligible for participation in the study by the investigator.
Target sample size
360
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 Bld 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 Bld 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
| 2024 | Year | 10 | Month | 18 | 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
191
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 | 09 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 31 | Day |
Other
Other related information
Study design:Cross-sectional study
Recruitment of subjects:Subjects in the study listed in the key inclusion criteria
Measurement:SNP information obtained from saliva DNA
Analysis:Relationship between functions of functional ingredients in food and SNPs and the prevalence of SNPs associated with functions of functional ingredients in food in the Japanese population
Management information
Registered date
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063592
