A verification study of actual feeling of the effects of royal jelly

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000036665
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Akiyama S, Hoshino T, Takara T, Mitsuo T. Reduction of fatigue with the intake of fresh royal jelly-an open-label, before-after trial-. Pharmacol Ther. 2021; 49(1): 127-141.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Study Completion: 2019-10-19
• Results First Posted: 2021-01-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 49

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 diagnosed with menopausal syndrome 6. Subjects who are currently taking medications (including herbal medicines) and supplements 7. Subjects who have experienced allergic reactions to bee stings 8. Subjects who have the medical history or under the treatment of asthma 9. Subjects who have the medical history or under the treatment of atopy 10. Subjects who are hypotension 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactation, or planning to become pregnant 13. 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 14. 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
Visual Analogue Scale (VAS) of fatigue * Conform to the methods of Japanese Society of Fatigue Science * Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change.

Secondary Outcome Measures

Name	Time	Method
1. Urinary 8-OHdG 2. Simplified Menopausal Index (SMI) 3. OSA sleep inventory MA version 4. Subjective symptoms (The Likert scale method) 5. Blood estradiol level 6. Blood free testosterone level 7. Blood lymphocytes / neutrophils ratio *1-3, 5-7 Assess the measured value at screening (before consumption) and at 12 weeks after consumption or calculate the amount of change. *4 Assess the measured value at screening (before consumption) and at 12 weeks after consumption.