Status:
COMPLETED
The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Lead Sponsor:
Medex d.o.o.
Conditions:
Upper Respiratory Tract Infection
URTI
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) amon...
Detailed Description
The investigational product (IP), Bio Gelee Royale Forte, contains royal jelly which is secreted by the hypopharyngeal and mandibular glands of nurse bees. Royal jelly is commonly used as a functional...
Eligibility Criteria
Inclusion
- Males and females between 18-65 years of age, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must self-report confirmation they are not pregnant, do not plan to become pregnant, and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence
- At least two self-reported incidences of URTI in the last 12 months
- Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, and sleep
- Agrees to maintain medications/supplements (particularly those used for immunity support) as much as possible throughout the study and not add new supplements to their routine
- Able and willing to complete all study assessments
- Provided voluntary and informed consent to participate in the study
- Generally healthy as determined by medical history with no unstable diagnosed medical conditions
Exclusion
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
- Self-reported allergy to bees or other insects
- Self-reported autoimmune disease or are immune compromised due to other factors
- Self-reported current or anticipated severe environmental allergies during the study period requiring medication or need for allergy shots
- Self-reported ongoing diagnosis of acute or chronic respiratory illness (e.g., asthma, chronic bronchitis, sinusitis, pharyngitis, chronic obstructive pulmonary disease (COPD))
- Self-reported ongoing and unstable diseases/conditions in the past three months, including:
- Arthritis and joint diseases
- Gastrointestinal diseases
- Hypertension
- Type I or type II diabetes
- Cardiovascular disease
- Kidney diseases
- Liver diseases
- Thyroid condition
- Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
- Self-reported cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Alcohol intake average of \>2 standard drinks per day
- Alcohol or drug abuse within the last 12 months that has required treatment
- Current use of prescribed and/or over-the-counter (OTC) medications/supplements that may impact the efficacy and/or safety of the investigational product
- Participation in other clinical research studies 30 days prior to screening
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor that may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Key Trial Info
Start Date :
October 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06573814
Start Date
October 25 2024
End Date
April 1 2025
Last Update
April 29 2025
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6B3L1