Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060657) titled 'A safety study on excessive consumption of a yogurt drink' on Feb. 12.
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 4 weeks excessive consumption of yogurt drinks in a randomized, double-blind, placebo-controlled, parallel-group trial
Basic objectives2 - Safety
Intervention:
Interventions/Control_1 - Oral intake of three bottles of test yogurt drink (112 g per bottle) once daily for 4 weeks.
Interventions/Control_2 - Oral intake of three bottles of test acidified milk (112 g per bottle) once daily for 4 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 02 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=R000069373
Disclaimer: Curated by HT Syndication.
