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

Last updated: November 1, 2024
Sponsor: Medex d.o.o.
Overall Status: Active - Recruiting

Phase

2

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

Placebo

Bio Gelee Royale Forte

Clinical Study ID

NCT06573814
24MDCFR01
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 asterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tuballigation, complete endometrial ablation) or have been post-menopausal for at least 1year prior to screening Or, Individuals of child-bearing potential must self-report confirmation they are notpregnant, do not plan to become pregnant, and agree to use a medically approvedmethod of birth control for the duration of the study. All hormonal birth controlmust have been in use for a minimum of three months. Acceptable methods of birthcontrol include:

  • Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

  • Double-barrier method

  • Intrauterine devices

  • Non-heterosexual lifestyle or agrees to use contraception if planning onchanging to heterosexual partner(s)

  • Vasectomy of partner at least 6 months prior to screening

  • Abstinence

  1. At least two self-reported incidences of URTI in the last 12 months

  2. Agrees to maintain current lifestyle as much as possible throughout the study,including diet, exercise, and sleep

  3. Agrees to maintain medications/supplements (particularly those used for immunitysupport) as much as possible throughout the study and not add new supplements totheir routine

  4. Able and willing to complete all study assessments

  5. Provided voluntary and informed consent to participate in the study

  6. Generally healthy as determined by medical history with no unstable diagnosedmedical conditions

Exclusion

Exclusion Criteria:

  1. Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study

  2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption ofinvestigational 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 studyperiod 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 pulmonarydisease (COPD))

  7. Self-reported ongoing and unstable diseases/conditions in the past three months,including:

  8. Arthritis and joint diseases

  9. Gastrointestinal diseases

  10. Hypertension

  11. Type I or type II diabetes

  12. Cardiovascular disease

  13. Kidney diseases

  14. Liver diseases

  15. Thyroid condition

  16. Self-reported surgery in the past three months or individuals who have plannedsurgery during the course of the study

  17. Self-reported cancer, except skin basal cell carcinoma completely excised with nochemotherapy or radiation with a follow up that is negative. Volunteers with cancerin full remission for more than five years after diagnosis are acceptable

  18. Alcohol intake average of >2 standard drinks per day

  19. Alcohol or drug abuse within the last 12 months that has required treatment

  20. Current use of prescribed and/or over-the-counter (OTC) medications/supplements thatmay impact the efficacy and/or safety of the investigational product

  21. Participation in other clinical research studies 30 days prior to screening

  22. Individuals who are unable to give informed consent

  23. Any other condition or lifestyle factor that may adversely affect the participant'sability to complete the study or its measures or pose significant risk to theparticipant

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 25, 2024
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • KGK Science Inc.

    London, Ontario N6B3L1
    Canada

    Active - Recruiting

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