Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056861) titled 'Effects of Test Food Intake on Oxidative Stress and Antioxidant Capacity Study (Subtitles: Effects on Oxidative Stress and Antioxidant Capacity Pre- and Post- Mental Load)' on Jan. 29.

Study Type: Interventional

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

Primary Sponsor: Institute - CPCC Company Limited

Condition: Condition - Male/female adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of continuous intake of the test food for four weeks on oxidative stress and antioxidant capacity pre- and post-mental load. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will replace one meal per day with the test food at lunch for four weeks. Interventions/Control_2 - Participants will consume their regular lunch without replacing it with the test food.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Male and female aged 20 to below 65 years at the time of consent acquisition. 2. Individuals who can consume the entire amount of the test food for lunch during the study period without any difficulty. 3. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents. Key exclusion criteria - 1. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties, three or more times a week. 2. Individuals who regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) with claims of antioxidant or stress-reduction properties and are unable to discontinue use from the time of consent acquisition. 3. Individuals taking medication that may impact the study (like birth control pills) at least once a week and cannot limit their use during the study period. 4. Individuals with regular exercise habits or who perform physical labor. 5. Individuals planning to engage in activities during the study period that might affect the results, such as exercise, physical labor, outdoor activities, travel, or business trips: - Intense or long-duration exercises. - Outdoor activities that involve extensive sun exposure or prolonged outdoor exposure. 6. Individuals with oral symptoms involving bleeding, such as bleeding from the gums noticeable without brushing or any other stimulation, where the water used for rinsing turns visibly colored. 7. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods. 8. Individuals with extremely irregular lifestyles, such as those working night shifts. 9. Individuals with highly irregular eating habits. 10. Individuals who are aware of excessive salt intake in their regular diet. 11. Individuals with excessive alcohol intake. 12. Individuals who smoke or have a history of smoking within the last six months from the date of consent meeting. Target Size - 45

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 01 Month 28 Day Date of IRB - 2025 Year 01 Month 17 Day Anticipated trial start date - 2025 Year 01 Month 30 Day Last follow-up date - 2025 Year 05 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064792

Disclaimer: Curated by HT Syndication.