UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057742 |
|---|---|
| Receipt number | R000065982 |
| Scientific Title | Effects of Soy-Based Plant Meat on Glucose Levels, Blood Lipids, and Appetite |
| Date of disclosure of the study information | 2025/04/30 |
| Last modified on | 2025/04/30 11:04:48 |
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Basic information
Public title
Effects of Soy-Based Plant Meat on Glucose Levels, Blood Lipids, and Appetite
Acronym
SoyMeat, Glucose, Blood Lipids, and Appetite Study
Scientific Title
Effects of Soy-Based Plant Meat on Glucose Levels, Blood Lipids, and Appetite
Scientific Title:Acronym
SoyMeat, Glucose, Blood Lipids, and Appetite Study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to elucidate the effects of repeated consumption of soy-based meat over a four-week period on glucose and lipid metabolism, appetite regulation, and gastrointestinal transit time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight and triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, free cholesterol, blood glucose, insulin, glycoalbumin, free fatty acids, AST, ALT, gamma GTP, leptin, highsensitivity CRP, and IL6 will be assessed before and after the 4 week intervention. Additional outcomes include glucose tolerance, gastrointestinal transit time, and appetite assessed at 0 to 120 minutes following test meal consumption.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Soy-Based Meat Condition:
Participants will consume soy based meat over a 4 week period, excluding weekdays, and outcome measures will be assessed before and after the intervention period.
Interventions/Control_2
Red Meat Condition:
Participants will consume red meat over a four-week period, excluding weekdays, and outcome measures will be assessed before and after the intervention period.
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Individuals with a BMI of 18.5 or higher and less than 25.
Key exclusion criteria
ndividuals taking medications that may affect metabolism or those with anorexia nervosa.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eri |
| Middle name | |
| Last name | Tajiri |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto-shi, Kumamoto
TEL
0963216691
e-tajiri@pu-kumamoto.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Tajiri |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto-shi, Kumamoto
TEL
0963216691
Homepage URL
e-tajiri@pu-kumamoto.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Community and Research Collaboration, Prefectural University of Kumamoto
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto
Tel
096-321-6612
puk-kenkyu@pu-kumamoto.ac.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
| 2025 | Year | 04 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | 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 | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065982
