Efficacy trial and long-term safety confirmation test- Efficacy and long-term safety of the test food TK61406 ingested as a single dose, in a double-blind, parallel-group comparison to placebo. - PRT-TT-MF-ES -TK61406-01

Tokai Pickling Co.,Ltd. Yasufumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda,Hiroshi Ono0 sites30 target enrollmentMarch 26, 2015

ConditionsA range of individuals from healthy to borderline conditions- Persons with tendency for constipation or diarrhea- Persons classified as normal to 1 degree of obesity- Persons classified with normal to 1 degree of average blood pressure

Overview

Phase: 未知
Intervention: Not specified
Conditions: A range of individuals from healthy to borderline conditions- Persons with tendency for constipation or diarrhea- Persons classified as normal to 1 degree of obesity- Persons classified with normal to 1 degree of average blood pressure
Sponsor: Tokai Pickling Co.,Ltd. Yasufumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda,Hiroshi Ono
Enrollment: 30
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 26, 2015

End Date

January 27, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Tokai Pickling Co.,Ltd. Yasufumi Ohba, Masataka Fujita, Mitsuru Satsukawa, Tetsuhiro Kawamoto, Mika Komura, Shoko Nishio, Tetsuya Iyoda,Hiroshi Ono

Eligibility Criteria

Inclusion Criteria

•Target subjects must satisfy the following selection criteria.
•1\) Men and women aged more than 20 years, and less than 50 years, at the time of giving informed consent.
•2\) Persons of Japanese nationality, and clear Asian descent.
•3\) Persons who, during the screening period, are not using chronic or seasonal drugs or medical equipment, and are not undergoing rehabilitation therapy.
•4\) Persons who have freely given consent and have understood the purpose of the study.
•5\) Persons with a tendency for constipation or diarrhea.
•Constipation: More than 2 days of constipation (consecutive or non\-consecutive) during the screening period from \-7 day to \-1 day.
•Diarrhea: More than 1 day of diarrhea within a period of 2 days during the screening period from \-7 day to \-1 day.
•Persons classified as normal to 1 degree of obesity (BMI of less than 30\.0 and more than 18\.5\) based on the new determination of obesity and diagnostic criteria 2011 of the Japanese Society for the Study of Obesity.
•7\) Blood pressure

Exclusion Criteria

•The following exclusion criteria apply to subjects.
•1\) Persons who have used drugs continuously or occasionally during the screening period from \-7 day to visit 0
•2\) Persons who have the following complications listed in the diagnostic criteria for obesity, based on the new determination of obesity and diagnostic criteria 2011 by the Japanese Society for the study of Obesity.
•\[Complications]
•\- Impaired glucose tolerance (type II diabetes, impaired glucose tolerance, etc.)
•\- Dyslipidemia
•\- High blood pressure (1 degree of hypertension excluded)
•\- Hyperuricemia, gout
•\- Coronary artery disease, including myocardial infarction, and angina pectoris
•\- Cerebral infarction, including cerebral thrombosis, transient ischemic attack