Clinical Trial: An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study- (Japan)

Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060298) titled 'An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study-' on Jan. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - AJINOMOTO AGF, INC.

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

Objective: Narrative objectives1 - The purpose of this study is to exploratory verify the effects of the test food on mood indicators by continuously ingesting the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test food A for 4 weeks Interventions/Control_2 - Intake of test food B for 4 weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1)Japanese males and females aged of 20-64 years. 2)Subjects who defecate 2-5 times from the screening test per week. 3)Subjects who can drink coffee every day 4)Subjects who can visit the study site on the scheduled date 5)Subjects who recognize the object and contents of the study and submit the written informed consent. Key exclusion criteria - 1)Subjects who regularly use laxatives or antibiotics 2)Subjects with a history or current history of serious diseases such as heart, liver, kidney, cancer, or tuberculosis (including cases of complications of other diseases) 3)Subjects who are currently receiving medication for illness or injury at the time of screening (excluding those prescribed medication for transient symptoms such as colds or hay fever) or who are scheduled to undergo surgery during the study period 4)Subjects who regularly use medicines, quasi-drugs, health foods and supplements (such as capsules) affecting the study. 5)Subjects who are shift workers or graveyard shift workers. 6)Subjects with extremely irregular daily habits and eating habits. 7)Subjects who will experience major changes in their living environment (such as moving, relocation, etc.) during the study period 8)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) or smokers. 9)Subjects who have ever felt unwell due to blood sampling. 10)Subjects who may have allergic symptoms to the test food 11)Subjects who donated 200 mL or more of blood within 1 month from the screening test or who are scheduled to do so during the study period 12)Subjects already participating in other clinical trials or who plan to participate in other clinical trials between the time of obtaining consent for this study and the final examination 13)Pregnant, breastfeeding, or likely to become pregnant during the study period 14)Subjects who are ineligible due to physician's judgment. Target Size - 75

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 14 Day Date of IRB - 2025 Year 12 Month 22 Day Anticipated trial start date - 2026 Year 01 Month 13 Day Last follow-up date - 2026 Year 03 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068975

Disclaimer: Curated by HT Syndication.