Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study -

Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study - - Safety evaluation of an excessive consumption of food material

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043825

Enrollment

Registered

2021-04-02

Start date

2021-04-26

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

Test food 5 times of serving size per day for 4 weeks, safety evaluations are performed at 0, 2, 4 and 6 weeks. Control food 5 times of serving size per day for 4 weeks, safety evaluations are pe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Males and females equal to or more than 20 years and less than 65 years of age 2)Subjects who visit on schedule days 3)Subjects who recognize the object and contents of the study and submit the written informed consent

Exclusion criteria

Exclusion criteria: 1)Subjects who BMI >=30.0 kg/m2 or <18.5 kg/m2 2)Subjects who have systolic blood pressure <90 mmHg 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4)Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 5)Subjects who regularly use drugs, health foods, and supplements 6)Females in pregnancy, lactation and scheduled pregnancy during test period. 7)Heavy alcoholic beverager(40g alcohol/day>=), heavy smoker(21 cigarettes/day>=) 8)Subjects who feel bad mood by blood collection in past 9)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 10)Night shift worker 11)Don't usually have breakfast 12)Subjects who plan business trip or trip for 10 days or more a month 13)Subjects who have allergy related to the study foods 14)Those who have been diagnosed with chronic constipation 15)Dysphagic person 16)Subjects already participating in other clinical trials 17)Subjects who are ineligible due to physician's judgement

Design outcomes

Primary

Measure	Time frame
Expression rate of side effect, Expression rate of Adverse event , clinical examination items, physiological examination items	—

Countries

Japan

Contacts

Public ContactToyotada Ashino

New drug research center, Inc. Clinical Research Dept.

t-ashino@ndrcenter.co.jp0123-34-0412

Outcome results