Effects of consumption of the test food on immunity of healthy Japanese subjects

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000038687
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

agahara H, Nagahara M, Ohmi N, Takahashi Y, Takara T. Effects of consumption of food containing Mulukhiyah (Corchorus olitorius; AOTSUBU) on immune function of healthy Japanese adults: a randomized, double-blind, placebo-controlled, parallel-group comparison study. New Food Industry. 2021; 63(3): 185-200

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-25
• Study Completion: 2020-03-27
• Results First Posted: 2021-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who regularly use anticoagulants, such as warfarin 7. Subjects who are smokers 8. Subjects who are diagnosed with pollen allergy 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. 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 enroll in anther clinical trial during trial period 12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scoring of immunological vigor * Assess the measured value at screening (before consumption) and at four weeks after consumption.