UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060470 |
|---|---|
| Receipt number | R000069184 |
| Scientific Title | Promoting Sustainable Food Systems Among Athletes: An Educational Intervention Combining Collaborative Pea Cultivation and Plant-Based Protein Supplementation |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/26 18:19:27 |
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Basic information
Public title
Promoting Sustainable Food Systems Among Athletes: An Educational Intervention Combining Collaborative Pea Cultivation and Plant-Based Protein Supplementation
Acronym
Promoting Sustainable Diets in Athletes Through Collaborative Pea Growing and Plant-Based Protein Supplement Use
Scientific Title
Promoting Sustainable Food Systems Among Athletes: An Educational Intervention Combining Collaborative Pea Cultivation and Plant-Based Protein Supplementation
Scientific Title:Acronym
Promoting Sustainable Food Systems Among Athletes: An Educational Intervention Combining Collaborative Pea Cultivation and Plant-Based Protein Supplementation
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine how providing nutrition education that combines cultivation activities conducted in collaboration with athletes and the intake of pea protein affects awareness of and behavior change toward Sustainable Diet System when making food choices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline to post-intervention in the proportion of plant-based protein supplement intake (%, proportion of total protein supplement intake)
Key secondary outcomes
Carbon-footprint-based quantification of the environmental impact of protein supplement intake across the production-to-consumption life cycle (kgCO2e; per participant and/or per day, as defined)
Measurement of sustainability awareness related to food choice (questionnaire score; instrument specified)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
In Intervention 1, participants complete a pre-intervention questionnaire, followed by SDS-focused nutrition education (a lecture). Participants then engage in pea cultivation activities in collaboration with athletes, with cultivation progress and related records shared among participants. In addition, participants freely consume pea protein and whey protein for one month each, with intake limited to a range that does not exceed each participant's habitual intake. Intake is quantified by collecting and measuring the remaining amount of the supplements. After completing the intervention, participants complete a post-intervention questionnaire.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
University students or athletes of the same age group (>=18 years), including those from this university and other universities; both sexes eligible.
Aged >=18 years.
Engaging in regular sport-specific training at least four times per week (American College of Sports Medicine, 2009).
Having a habitual whey protein supplement intake of at least twice per week during the past month (habitual use category based on Barrack et al., 2020).
Having received a sufficient explanation of the study and, throughout the study period (approximately 4 months), being able to participate in the orientation session, nutrition education, cultivation record-keeping, intake record-keeping, and pre- and post-intervention questionnaires; able to use communication tools such as LINE; and providing written informed consent to participate voluntarily.
Key exclusion criteria
Exclusion criteria
The protein supplements used in this study are derived from peas and milk. Individuals with a nut allergy or a milk allergy are excluded for safety reasons, as intake may trigger an allergic reaction.
Individuals who habitually consume only plant-based protein supplements are excluded because a pre-post comparison would not be feasible and this does not align with the study objectives.
Discontinuation criteria
Withdrawal from participation or withdrawal of consent at the participant's request.
Occurrence of physical discomfort/adverse symptoms considered to be caused by intake of the provided foods.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Yasuda |
Organization
Tokai University
Division name
Shonan Campus, Faculty of Health Sciences
Zip code
259-1292
Address
4-1-1 Kitakaname, Hiratsuka, Kanagawa 259-1292, Japan
TEL
0463-63-4394
yasuda.jun.w@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yasuda |
Organization
Tokai University
Division name
Shonan Campus, Faculty of Health Sciences
Zip code
259-1292
Address
Kanagawa 259-1292, Japan
TEL
0463634394
Homepage URL
yasuda.jun.w@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
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
Tokai University Ethics Committee for Research Involving Human Subjects
Address
Kanagawa 259-1292, Japan
Tel
0463-58-1211
research1117@tokai.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
東海大学湘南キャンパス（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069184
