Tokyo, July 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062179) titled 'A clinical study to evaluate the safety of long-term intake of the test food' on July 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Suntory Holdings Limited

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

Objective: Narrative objectives1 - To evaluate the safety of 12-week continuous intake of the test food in healthy male and female subjects Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Daily intake of test food for 12 weeks Interventions/Control_2 - Daily intake of control food for 12 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1)Those who aged 20 years or older at the time of IC acquisition and under 65 years old at the end of food intake (2)Those who can visit the designated facility on the scheduled visit date (3)Those who have submitted written informed consent after fully understanding the purpose and content of this study Key exclusion criteria - (1) Those with systolic blood pressure less than 90 mmHg (2) Women who wish to become pregnant, are/might be pregnant or lactating during the study (3) Those who have taken over 200 mL whole blood or blood donation within 4 weeks before the start of the intake (4) Men who have taken over 400 mL whole blood within 12 weeks before the start of intake (5) Women who have taken over 400 mL whole blood within 16 weeks before the start of intake (6) Men who have taken over 1,200 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (7) Women who have taken over 800 mL whole blood total (including the sampling of this study) within 12 months before the start of intake (8) Those who are participating in other study or planning to participate or participated within the past 4 weeks (9) Those who meet any of the following: a) suffering from heart, liver, or kidney disease (including complications of other diseases) b) having a history of cardiovascular disease c) diabetes d) allergic to test food e) having a history of cancer or tuberculosis f) positive or false-positive by infectious disease test (10) Those who are receiving any treatment at the time of screening (11) Those who regularly use pharmaceuticals (including quasi-drugs), foods for specified health use, foods with functional claims or health foods (12) Those who smoke an average of 21 or more cigarettes in a day (13) Those who drink an average of over 60 g of pure alcohol in a day (14) Those who have an extremely irregular eating habit (15) Shift workers or late-night workers (16) Others who are judged inappropriate for participant by the investigator Target Size - 48

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 16 Day Anticipated trial start date - 2026 Year 07 Month 13 Day Last follow-up date - 2027 Year 01 Month 12 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071122

Disclaimer: Curated by HT Syndication.