Clinical trial NCT06573814: The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Official title: A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Respiratory Tract Infection
URTI
Keywords: Upper Respiratory Tract Infection
Safety and efficacy
Royal Jelly
Lead sponsor: Medex d.o.o.
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Additionally, the safety and tolerability of Bio Gelee Royale Forte, as compared to placebo, will be measured by the occurrence of and/or changes in treatment emergent adverse effects.

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 food due to its antibacterial, anti-oxidant, anti-inflammatory, and anti-aging properties. While current evidence suggests royal jelly may play a role in improving human health, little is known about the effects of royal jelly on immune function. Therefore, the objective of this study is to investigate the efficacy of Bio Gelee Royale Forte compared to placebo on immune health in a healthy adult population with self-reported susceptibility to URTIs during cold and flu season.

Eligibility criteria: Inclusion Criteria:

1. Males and females between 18-65 years of age, inclusive
2. 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
3. At least two self-reported incidences of URTI in the last 12 months
4. Agrees to maintain current lifestyle as much as possible throughout the study, including diet, exercise, and sleep
5. 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
6. Able and willing to complete all study assessments
7. Provided voluntary and informed consent to participate in the study
8. Generally healthy as determined by medical history with no unstable diagnosed medical conditions

Exclusion Criteria:

1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product or placebo ingredients
3. Self-reported allergy to bees or other insects
4. Self-reported autoimmune disease or are immune compromised due to other factors
5. Self-reported current or anticipated severe environmental allergies during the study period requiring medication or need for allergy shots
6. Self-reported ongoing diagnosis of acute or chronic respiratory illness (e.g., asthma, chronic bronchitis, sinusitis, pharyngitis, chronic obstructive pulmonary disease (COPD))
7. Self-reported ongoing and unstable diseases/conditions in the past three months, including:

   1. Arthritis and joint diseases
   2. Gastrointestinal diseases
   3. Hypertension
   4. Type I or type II diabetes
   5. Cardiovascular disease
   6. Kidney diseases
   7. Liver diseases
   8. Thyroid condition
8. Self-reported surgery in the past three months or individuals who have planned surgery during the course of the study
9. 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
10. Alcohol intake average of \>2 standard drinks per day
11. Alcohol or drug abuse within the last 12 months that has required treatment
12. Current use of prescribed and/or over-the-counter (OTC) medications/supplements that may impact the efficacy and/or safety of the investigational product
13. Participation in other clinical research studies 30 days prior to screening
14. Individuals who are unable to give informed consent
15. 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

Primary outcomes:
measure: The difference in frequency, severity, and duration of upper respiratory tract infections (URTI).
timeFrame: Day -14 to day 84
Secondary outcomes:
measure: The difference in frequency of URTIs from day -14 to day -1.
timeFrame: day -14 to day -1
measure: The difference in frequency of URTIs from day -14 to day 84.
timeFrame: day -14 to day 84
measure: The difference in severity of URTI symptoms from day -14 to day -1.
timeFrame: day -14 to day -1
measure: The difference in severity of URTI symptoms from day -14 to day -1.
timeFrame: day -14 to day -1
measure: The difference in severity of URTI symptoms from day -14 to day 84.
timeFrame: day -14 to day 84
measure: The difference in severity of URTI symptoms from day -14 to day 84.
timeFrame: day -14 to day 84
measure: The difference in duration of URTI symptoms from day -14 to day -1.
timeFrame: day -14 to day 84
measure: The difference in duration of URTI symptoms from day -14 to day 84.
timeFrame: day -14 to day 84
measure: Severity of URTI symptoms over the 84-day supplementation period.
timeFrame: baseline to day 84
measure: The difference in proportion of participants with incidence of URTIs from day -14 to day -1.
timeFrame: day -14 to day -1
measure: The difference in proportion of participants with incidence of URTIs from baseline to day 84.
timeFrame: baseline to day 84
measure: The difference in proportion of participants with incidence of URTIs from day -14 to day 84.
timeFrame: day -14 to 84
measure: The difference in number of sick days from day -14 to day -1.
timeFrame: day -14 to day -1
measure: The difference in number of sick days from baseline to day 84.
timeFrame: baseline to day 84
measure: The difference in number of sick days from day -14 to day 84.
timeFrame: day -14 to day 84
measure: Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1.
timeFrame: day -14 to day -1
measure: Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84.
timeFrame: baseline to day 84
measure: Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84.
timeFrame: day -14 to day 84
Other outcomes:
measure: Incidence of post-emergent adverse effects between day -14 to day 84.
timeFrame: day -14 to day 84
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley, PhD
role: PRINCIPAL_INVESTIGATOR
References: