UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061516 |
|---|---|
| Receipt number | R000070396 |
| Scientific Title | Effects of Plant Protein on Health Functions |
| Date of disclosure of the study information | 2026/05/31 |
| Last modified on | 2026/05/11 11:27:18 |
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Basic information
Public title
Effects of Plant Protein on Health Functions
Acronym
Effects of Plant Protein on Health Functions
Scientific Title
Effects of Plant Protein on Health Functions
Scientific Title:Acronym
Effects of Plant Protein on Health Functions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether plant protein exhibits its health-promoting effects when ingested in a confectionery format.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum triglyceride levels and blood glucose levels
Key secondary outcomes
1)Routine qualitative urinalysis (urine glucose, urine protein, urine occult blood, etc.)
2)Inflammatory markers in blood biochemical examination (high-sensitivity CRP, etc.)
3)Changes in gut microbiota composition assessed by 16S rRNA amplicon sequencing
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
Crunchy chocolate containing plant protein
Interventions/Control_2
Crunchy chocolate containing whey protein isolate
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1)Employees directly employed by Fuji Oil Co., Ltd. who are able to visit the health management office on the scheduled blood sampling day.
2)Individuals who have provided written informed consent to participate in the study.
3)Individuals who are able to communicate in Japanese.
Key exclusion criteria
1)Individuals receiving pharmacological treatment for diabetes mellitus or dyslipidemia
(those receiving only dietary and/or exercise therapy are eligible).
2)Individuals who have experienced abnormal symptoms such as feeling unwell or a drop in blood pressure during or after blood collection
3)Individuals with food allergies, including allergy to soybeans, birch pollen, cocoa, etc.
4)Other individuals deemed ineligible for this study by an occupational physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ota |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai-shi, Ibaraki, Japan.
TEL
0297-52-6325
ota.satoshi@so.fujioil.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ota |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai-shi, Ibaraki, Japan.
TEL
0297-52-6325
Homepage URL
ota.satoshi@so.fujioil.co.jp
Sponsor or person
Institute
Fuji Oil Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hara Internal Medicine Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuji Oil IRB
Address
4-3 Kinunodai, Tsukubamirai-shi, Ibaraki, Japan.
Tel
0297-52-6325
nakano.mikio@so.fujioil.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
| 2026 | Year | 05 | Month | 31 | 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
30
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 | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 11 | Day |
Last modified on
| 2026 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070396
