Tokyo, Jan. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060427) titled 'A safety study on long-term consumption of a yogurt drink' on Jan. 22.

Study Type: Interventional

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

Primary Sponsor: Institute - CPCC Company Limited

Condition: Condition - N/A Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the safety of 12 weeks consumption of a yogurt drink in a randomized, double-blind, placebo-controlled, parallel-group trial. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Oral intake of the test food (yogurt drink, 112 g) once daily for 12 weeks. Interventions/Control_2 - Oral intake of placebo food (acidified milk, 112 g) daily for 12 weeks.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - (1) Healthy Japanese male and female aged 20 to 64 years at the time of consent. (2) Subjects with a BMI >= 18.5 and < 30.0. (3) Subjects who provide written informed consent. Key exclusion criteria - (1) Subjects who have serious disease. (2) Subjects who have taken any medication within 3 days prior to the screening test. (3) Subjects with an average daily alcohol intake exceeding 40 g. (4) Subjects unable to abstain from alcohol for 1 day prior to the examination. (5) Subjects whose daily routines are irregular due to night work or shift work. (6) Subjects who are expected to be unable to consume the study food for 6 or more days due to extended travel or similar circumstances. (7) Subjects have participated in other research within 4 weeks prior to consent or plan to participate in other research after consent. (8) Subjects who are pregnant, breastfeeding or intend to become pregnant during this study. (9) Subjects who tend to develop diarrhea after consuming dairy products. (10) Subject with food allergies. (11) Subjects who donated blood component or 200 mL of whole blood within 1 month before this study. (12) Males who donated 400 mL of whole blood within 3 months before this study. (13) Females who donated 400 mL of whole blood within 4 months before this study. (14) Males whose total blood draw volume, including the planned volume for this study, exceeds 1,200 mL within 12 months before this study. (15) Females whose total blood draw volume, including the planned volume for this study, exceeds 800 mL within 12 months before this study. (16) Subjects deemed unsuitable by the investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 27 Day Date of IRB - 2025 Year 10 Month 24 Day Anticipated trial start date - 2026 Year 01 Month 23 Day Last follow-up date - 2026 Year 04 Month 17 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069024

Disclaimer: Curated by HT Syndication.