Safety evaluation of the test food containing rose hip extract intake of 5 times more than regular daily intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000034151
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-14
• Study Completion: 2018-12-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, glucose-6-phosphate dehydrogenase deficiency, sickle cell disease, hemochromatosis, thalassemia (Mediterranean anemia), or any other chronic diseases 4. Subjects who have disorder related to iron such as anemia 5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 6. Subjects who are currently taking medications (including herbal medicines) and dietary supplements (health food) 7. Subjects who are an allergic reaction to medications and/or the test food related products 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who work late-night shift and the life-styles are irregular 11. Subjects who are judged as ineligible to participate in the study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Physical examination 2. Urinalysis 3. Blood test 4. Subjective symptoms (the Likert scale) * Assess the measured value at screening (before consumption) and at 2 and 4 weeks after consumption and calculate the amount of change.