Tokyo, Jan. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060352) titled 'Test to confirm the effects of consuming the test food for three months' 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 - EP Mediate Co., Ltd.

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - Exploratorily evaluate the effects of test food intake on the intestinal environment and the body. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Daily intake of test food A once a day for 12 consecutive weeks Interventions/Control_2 - Daily intake of test food B once a day for 12 consecutive weeks

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy males and females from 20 to 65 years of age (2) Subjects whose lunch consists only of the test food and who have no difficulty consuming the entire portion (3) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study Key exclusion criteria - Subjects (1)whose blood pressure in the examination room during screening is at or above the level classified as high blood pressure (2)who do not have the habit of eating lunch or whose eating habits are extremely irregular (3)who cannot stop consuming foods and beverages related to the study from the time of the screening (4)with a medical history of diseases requiring dietary and exercise therapy under a doctor's supervision (5)who regularly take health supplements and cannot stop taking them during the study period (6)who regularly use pharmaceutical drugs or quasi-drugs and cannot restrict their intake during the research period (7)currently receiving medical treatment for gastrointestinal diseases that could affect the research, or those with a history of gastrointestinal surgery (8)suspected of having, currently being treated for, or with a history of disorders related to bowel movements, sleep, stress, or fatigue (9)who have shown abnormalities in clinical test values or cardiopulmonary function and are deemed unsuitable for participation in the study (10)who may be at risk of developing allergies in relation to the research (11)who require regular medication, those currently undergoing treatment for a disease, and those with a history of severe diseases that required medication treatment (12)who work in shifts, night shifts, or have irregular daily schedules (13)Heavy drinkers and smoker (14)who have participated in other clinical studies from within one month before the date of consent until four weeks after the end of the trial (15)who plan to become pregnant or breastfeed during the study period (16)expected to experience significant changes in their living environment during the research period (17)whose blood donation volume before the start of the study exceeds the regulations (18)who are aware of imbalances in nutritional intake (19)deemed inappropriate as subjects by the responsible investigator (20)using implanted medical electrical devices Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 25 Day Date of IRB - 2025 Year 12 Month 25 Day Anticipated trial start date - 2026 Year 01 Month 29 Day Last follow-up date - 2026 Year 06 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069046

Disclaimer: Curated by HT Syndication.