Tokyo, Nov. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056164) titled 'Verification of impacts on psychological state by lactic acid bacteria intakes' on Nov. 14.

Study Type: Interventional

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

Primary Sponsor: Institute - Centan Inc.

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

Objective: Narrative objectives1 - In order to verify some kind of effect on psychological state by test-food intakes Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake test food on the day. Wash out. Intake placebo food on the day. Interventions/Control_2 - Intake placebo food on the day. Wash out. Intake test food on the day.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Japanese males and females aged 20 or more and less than 45 at the time of written informed consent. (2) Subjects who have normal eyesight (including corrected eyesight) and hearing ability. (3) Subjects with no allergy to dairy products or fermented foods. (4) Subjects who can avoid consuming lactic acid bacteria beverages or fermented food containing lactic acid bacteria for three days prior to participating in the study. (5) Subjects whose daily rhythm is not extremely irregular. (6) Subjects with a BMI of 18.5 or more but less than 30. (7) Subjects who do not consume excessive amounts of alcohol. (8) Subjects who do not smoke excessively. (9) Subjects who do not consume excessive amounts of caffeine. (10) Subjects who have never suffered external head injuries severe enough to cause loss of consciousness. Key exclusion criteria - (1) Subjects with a history of cardiovascular disease, psychiatric disorder, gastrointestinal disorder, or a serious disease. (2) Subjects who are currently being treated for an illness or injury or who are taking regular medication. (3) Subjects who had significant health problems in the two months leading up to the day of participation. (4) Subjects whose social life is affected by irritability, drowsiness, bad mood, abdominal pain, constipation/diarrhea, fatigue, etc. associated with menstruation. (5) Subjects who are planning to get pregnant during the test period after the day of informed consent or are currently pregnant and lactating. (6) Subjects who have or had infected with COVID-19 within the past two weeks, or who live with someone who has or had infected with COVID-19 within the past two weeks. (7) Subjects who have experienced a major life event within the three months prior to obtaining consent, or who have plans to do so during the trial period. (8) Subjects who are participating in other clinical trials at the time of obtaining consent, and who plan to participate in other clinical trials within 3 months from the end of the study to the start of the main study of the study, or after consenting to participate in the study. (9) Subjects being determined as ineligible for participation by the principal investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 11 Month 14 Day Date of IRB - 2024 Year 11 Month 14 Day Anticipated trial start date - 2024 Year 11 Month 19 Day Last follow-up date - 2024 Year 12 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064175

Disclaimer: Curated by HT Syndication.