Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060470) titled 'Promoting Sustainable Food Systems Among Athletes: An Educational Intervention Combining Collaborative Pea Cultivation and Plant-Based Protein Supplementation' on Jan. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokai University

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 years-old =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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069184

Disclaimer: Curated by HT Syndication.