JPRN-UMIN000052187
Completed
未知
A verification study of the improving effect of consumption of the test food on sleep quality: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the improving effect of consumption of the test food on sleep quality
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ORTHOMEDICO Inc.
- Enrollment
- 44
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 are currently undergoing treatment of insomnia or sleep disorder 5\. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6\. Subjects who are currently taking medications (including herbal medicines) and supplements 7\. Subjects who are allergic to medicines and/or the test food related products 8\. Subjects who live with their infants less than one year old 9\. Subjects who sleep with their children (one to six years old) 10\. Subjects who live with requiring long\-term care persons 11\. Subjects who sleep with more than one person 12\. Subjects whose sleeping time or habit is irregular due to work such as a late\-night shift 13\. Subjects whose dinner time is irregular 14\. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 15\. 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 16\. Subjects who are judged as ineligible to participate in this study by the physician
Outcomes
Primary Outcomes
Not specified
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