UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052313 |
|---|---|
| Receipt number | R000059717 |
| Scientific Title | The Effect of Plant-Based Meat Substitutes on Subsequent Glycemic Variability in Healthy Adults |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2025/03/28 13:31:21 |
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Basic information
Public title
The Effect of Plant-Based Meat Substitutes on Subsequent Glycemic Variability in Healthy Adults
Acronym
The Effect of Plant-Based Meat Substitutes on Subsequent Glycemic Variability in Healthy Adults
Scientific Title
The Effect of Plant-Based Meat Substitutes on Subsequent Glycemic Variability in Healthy Adults
Scientific Title:Acronym
The Effect of Plant-Based Meat Substitutes on Subsequent Glycemic Variability in Healthy Adults
Region
| Japan |
Condition
Condition
18~24 years old healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of the use of plant-based meat substitutes on glycemic variability in healthy adults.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of the use of plant-based meat substitutes on subsequent glycemic variability and blood lipid dynamics in healthy adults.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood parameters: blood glucose (0 min before, 30, 60, 90, 120 min after meal), insulin, triglycerides, free fatty acids (0 min before, 30, 120 min after meal)
Appetite (0 min before, 30 min after, 60 min, 90 min, 120 min)
75g OGTT blood glucose (0 min, 30 min, 60 min, 90 min, 120 min)
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
The test meal will be curry, with plant-based meat substitutes, consumed as breakfast.
Interventions/Control_2
The test meal will be curry and animal meat will be consumed as breakfast.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)18.5 <= BMI < 25.0 kg/m2 2) No diabetes, hypertension, dyslipidemia, or anorexia nervosa 3) Not pregnant or lactating 4) No medications or supplements that affect metabolism
Key exclusion criteria
1) BMI < 18.5 kg/m2 or BMI >= 25.0 kg/m2 2) Patients with diabetes, hypertension, dyslipidemia, or anorexia nervosa 3) Pregnant or lactating women 4) Those taking medications or supplements that affect their metabolism
Target sample size
30
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 Environment and Symbiosis
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
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 Environment and Symbiosis
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto City, Kumamoto Prefecture
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
Grants-in-Aid for Scientific Research Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Other
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 Prefecture
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
| 2023 | Year | 09 | Month | 27 | 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
It was suggested that increasing consumption of plant-based meat alternatives containing soy could potentially have significant appetite-suppressing effects. Additionally, since improvements in blood glucose and blood lipid levels might be due to the effect of improved insulin resistance through long-term consumption, it is necessary to examine the effects of long-term consumption of plant-based meat alternatives in future studies.
Results date posted
| 2025 | Year | 03 | Month | 28 | Day |
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 | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059717
