A safety study on excessive consumption of a yogurt drink.

A safety study on excessive consumption of a yogurt drink. - A safety study on excessive consumption of a yogurt drink.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060657

Enrollment

Registered

2026-02-12

Start date

2026-02-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Oral intake of three bottles of test yogurt drink (112 g per bottle) once daily for 4 weeks. Oral intake of three bottles of test acidified milk (112 g per bottle) once daily for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Number of subjects and events for adverse events (AEs) and for AEs related to the study products.	—

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Director

cpcc-contact@cpcc.co.jp03-6625-9001

Outcome results