The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults

Phase 2

Not yet recruiting

• Conditions: Upper Respiratory Tract Infection; URTI

• Registration Number: NCT06573814
• Lead Sponsor: Medex d.o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Males and females between 18-65 years of age, inclusive<br><br> 2. Females not of child-bearing potential, defined as those who have undergone a<br> sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal<br> ligation, complete endometrial ablation) or have been post-menopausal for at least 1<br> year prior to screening<br><br> Or,<br><br> Individuals of child-bearing potential must confirm they are not pregnant, do not<br> plan to become pregnant, and agree to use a medically approved method of birth<br> control for the duration of the study. All hormonal birth control must have been in<br> use for a minimum of three months. Acceptable methods of birth control include:<br><br> - Hormonal contraceptives including oral contraceptives, hormone birth control<br> patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable<br> contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)<br><br> - Double-barrier method<br><br> - Intrauterine devices<br><br> - Non-heterosexual lifestyle or agrees to use contraception if planning on<br> changing to heterosexual partner(s)<br><br> - Vasectomy of partner at least 6 months prior to screening<br><br> - Abstinence<br><br> 3. At least two self-reported incidences of URTI in the last 12 months<br><br> 4. Agrees to maintain current lifestyle as much as possible throughout the study,<br> including diet, exercise, and sleep<br><br> 5. Agrees to maintain medications/supplements (particularly those used for immunity<br> support) as much as possible throughout the study and not add new supplements to<br> their routine<br><br> 6. Able and willing to complete all study assessments<br><br> 7. Provided voluntary and informed consent to participate in the study<br><br> 8. Generally healthy as determined by medical history with no unstable diagnosed<br> medical conditions<br><br>Exclusion Criteria:<br><br> 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during<br> the study<br><br> 2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of<br> investigational product or placebo ingredients<br><br> 3. Self-reported allergy to bees or other insects<br><br> 4. Self-reported autoimmune disease or are immune compromised due to other factors<br><br> 5. Self-reported current or anticipated severe environmental allergies during the study<br> period requiring medication or need for allergy shots<br><br> 6. Self-reported ongoing diagnosis of acute or chronic respiratory illness (e.g.,<br> asthma, chronic bronchitis, sinusitis, pharyngitis, chronic obstructive pulmonary<br> disease (COPD))<br><br> 7. Self-reported ongoing and unstable diseases/conditions in the past three months,<br> including:<br><br> 1. Arthritis and joint diseases<br><br> 2. Gastrointestinal diseases<br><br> 3. Hypertension<br><br> 4. Type I or type II diabetes<br><br> 5. Cardiovascular disease<br><br> 6. Kidney diseases<br><br> 7. Liver diseases<br><br> 8. Thyroid condition<br><br> 8. Self-reported surgery in the past three months or individuals who have planned<br> surgery during the course of the study<br><br> 9. Self-reported cancer, except skin basal cell carcinoma completely excised with no<br> chemotherapy or radiation with a follow up that is negative. Volunteers with cancer<br> in full remission for more than five years after diagnosis are acceptable<br><br> 10. Alcohol intake average of >2 standard drinks per day<br><br> 11. Alcohol or drug abuse within the last 12 months that has required treatment<br><br> 12. Current use of prescribed and/or over-the-counter (OTC) medications/supplements that<br> may impact the efficacy and/or safety of the investigational product (see Sections<br> 7.3.1 and 7.3.2)<br><br> 13. Participation in other clinical research studies 30 days prior to screening<br><br> 14. Individuals who are unable to give informed consent<br><br> 15. Any other condition or lifestyle factor that may adversely affect the participant's<br> ability to complete the study or its measures or pose significant risk to the<br> participant

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).