Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060366) titled 'Verification of the Effects of Growing Vegetables on the Physical and Mental Health of Children and Their Parents' on Jan. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - KAGOME CO., LTD
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the impact of cultivation experiences on the stress levels and estimated vegetable intake of children and their parents.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - No treatment
Interventions/Control_2 - Vegetable cultivation
Eligibility:
Age-lower limit - 7
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - As of February 2026, primary school pupils in Year 2 attending primary schools in Otsu City, Kusatsu City, Ritto City, and Moriyama City within Shiga Prefecture, and guardians residing with said pupils.
Key exclusion criteria - 1. Individuals who regularly cultivate vegetables
2. Individuals for whom it is difficult to collect the required hair length (1 cm) for measurement
3. Individuals living with family members who routinely cultivate edible plants such as vegetables and fruits
4. Individuals planning extended absences (2 weeks or longer) during the study period
5. Individuals who have undergone hair dyeing, bleaching, or straightening within the past month
6. Individuals with major life events scheduled during the study period (weddings, moving house, childbirth, job transfers, etc.)
7. Individuals who have suffered from or are undergoing treatment for the following conditions within one year prior to the trial start date: Cushing's
syndrome, Addison's disease, thyroid disorders, diabetes mellitus, chronic kidney disease, nephrotic syndrome, malignant tumours, depression, bipolar disorder, schizophrenia, post-traumatic stress disorder, stroke, heart failure, coronary artery disease, asthma, peripheral arterial disease, ulcerative colitis, Crohn's disease, hospitalisation (within the past year), surgery (within the past year), tuberculosis
8. Any other person who is deemed inappropriate by the principal investigator.
Target Size - 120
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 08 Day
Date of IRB - 2025 Year 12 Month 08 Day
Anticipated trial start date - 2026 Year 05 Month 16 Day
Last follow-up date - 2026 Year 12 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069030
Disclaimer: Curated by HT Syndication.