Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects: an open-label trial - Effects of consumption of the test food on body fat, intestinal bacteria, and other vital data in healthy Japanese subjects

ORTHOMEDICO Inc.0 sites12 target enrollmentNovember 30, 2022

ConditionsHealthy Japanese subjects

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Japanese subjects
Sponsor: ORTHOMEDICO Inc.
Enrollment: 12
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 30, 2022

End Date

December 3, 2023

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

ORTHOMEDICO Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2\. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3\. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4\. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5\. Subjects who are currently taking medications (including herbal medicines) and supplements 6\. Subjects who are a smoker 7\. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1\.5 cans of canned chu\-hi, 180 mL: 1 go of sake or about 1\.5 glasses of wine, 90 mL: half\-go with shochu, 60 mL: a glass of whiskey brandy (double)} 8\. Subjects whose sleeping time or habit is irregular due to work such as a late\-night shift 9\. Subjects whose meal time is irregular 10\. Subjects who are allergic to medicines and/or the test food related products (particularly, wheat, beef, pork, eggs, chicken, soy, milk ingredients, sesame, mackerel, shrimp, almonds, bananas, cashew nuts, walnuts, salmon, peach, or Japanese yam) 11\. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 12\. Subjects who suffer from COVID\-19 13\. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14\. Subjects who are judged as ineligible to participate in this study by the physician