Tokyo, Dec. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059966) titled 'Evaluation program for dietary support' on Dec. 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - TOPPAN Inc.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate how health awareness and health behaviors are changed in adults aged 35 years or older by the consumption of frozen meals twice a week), in combination with a habit-formation program and guidance by a registered dietitian for seven weeks. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of frozen meals twice a week for 7 weeks. To record daily meals in the specified app. Advice from a registered dietitian. Interventions/Control_2 - Intake of frozen meals twice a week for 7 weeks. To record daily meals in the specified app.

Eligibility: Age-lower limit - 35 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate by providing electronic consent. 2.Persons who are 35 years old or more and work at the TOPPAN Koishikawa Headquarters Building. 3.Including persons who subject to specific health guidance with /without currently taking medication. Key exclusion criteria - 1.Persons who have a serious disease history. 2.Persons who have food allergies. 3.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam. 4.Persons who were judged as inappropriate for study participants by the principal investigator. 5.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding. 6.Persons who cannot agree to the provision of personal information required for the study, or who cannot agree to the collection and use of data in this project (such as app usage logs, chat logs, and dietary records). Target Size - 200

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 11 Day Anticipated trial start date - 2025 Year 12 Month 08 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068588

Disclaimer: Curated by HT Syndication.