Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059726) titled 'Clinical Study of Psychological Impact of Food Ingredients: a placebo-controlled double-blind crossover study' on Nov. 11.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Macromill, Inc.

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

Objective: Narrative objectives1 - To investigate the psychological impact of food ingredients in humans, the study on the subjective assessment of psychological impact and objective assessment to support the subjective assessment will be conducted. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake the placebo beverage twice daily (at the start of morning and afternoon work shifts) for 5 days. Interventions/Control_2 - Intake the test beverage twice daily (at the start of morning and afternoon work shifts) for 5 days.

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - 1. Aged 20 to under 45 at the time of informed consent. 2. Japanese male 3. BMI of less than 30.0 kg/m2 4. Those who does not smoke (who have not been smoking for the last year) 5. Users of an iPhone with iOS 16 or later, or an Android device with OS 10 or later 6.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent. Key exclusion criteria - 1. Subjects receiving any medication or Chinese medication (except drugs as needed). 2. Subjects with history or current diagnosis of serious heart, liver, kidney, or GI tract diseases. 3. Subjects unable to evaluate flavor/aroma due to pollinosis (spring/grass pollen) or allergic rhinitis (seasonal/perennial). 4. Subjects under doctor-supervised dietary or exercise therapy. 5. Subjects regularly using commercial drugs, quasi-drugs, food for specified health use, or food affecting ANS or sleep (eligible if usage can be stopped after IC and during study). 6. Subjects with incompatible anatomy/condition for heartbeat measurements (e.g., thick body hair, pacemaker). 7. Subjects whose smartwatch measurement may be impaired (e.g., dense body hair on wrist). 8. Subjects who rash from chest electrodes or wrist smartwatch measurement. 9. Subjects with excessive alcohol intake (alcohol equivalent 60 g/day or more) 10. Subjects with excessive caffeine intake (400 mg/day or more). 11. Subjects with significantly irregular eating habits/lifestyles (e.g., shift/night workers). 12. Subjects who participated in another clinical study (other than ASAHI psych eval) within 1 month prior to IC, or who are currently/will be participating during study or within 4 weeks after end. 13. Subjects who experienced significant life stress (e.g., moving, job change, separation) within 3 months prior to IC, or who will have such an event during the study. 14. Subjects unable to abstain from caffeine during the study period (on weekdays). 15. Subjects unable to abstain from alcohol consumption from the day prior to 1st test food intake until the final day of intake. 16. Subjects with drug and/or food allergies. 17. Subjects who are unemployed, cannot work remotely, or whose work environment/duties are unstable during the study. 18. Subjects considered ineligible by the investigator. Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 30 Day Date of IRB - 2025 Year 10 Month 31 Day Anticipated trial start date - 2025 Year 11 Month 11 Day Last follow-up date - 2026 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068267

Disclaimer: Curated by HT Syndication.