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

NCT06573814 | Completed Phase 2

• 1 other identifier: 24MDCFR01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Respiratory Tract Infection; URTI

Keywords

Upper Respiratory Tract Infection; Safety and efficacy; Royal Jelly

Outcome Measures

Primary Outcomes (1)

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

  The difference in frequency, severity, and duration of URTIs as assessed by the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire over the 84-day supplementation period between Bio Gelee Royale Forte and Placebo. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome.

  Day -14 to day 84

Secondary Outcomes (18)

• The difference in frequency of URTIs from day -14 to day -1.

  day -14 to day -1

• The difference in frequency of URTIs from day -14 to day 84.

  day -14 to day 84

• The difference in severity of URTI symptoms from day -14 to day -1.

  day -14 to day -1

• The difference in severity of URTI symptoms from day -14 to day -1.

  day -14 to day -1

• The difference in severity of URTI symptoms from day -14 to day 84.

  day -14 to day 84

Other Outcomes (1)

• Incidence of post-emergent adverse effects between day -14 to day 84.

  day -14 to day 84

Study Arms (2)

Bio Gelee Royale Forte

EXPERIMENTAL

Participants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily.

Dietary Supplement: Bio Gelee Royale Forte

Placebo

PLACEBO COMPARATOR

Participants will be instructed to take two capsules of study product in the morning on empty stomach once per day for 98 days. If there is an incidence of URTI between enrollment and Day-14, participant will be instructed to start study product intake three days after symptom resolution. If a dose is missed participants are instructed to take the dose approximately two hours after a meal. Participants will be advised not to exceed two capsules daily.

Other: Placebo

Interventions

Bio Gelee Royale Forte DIETARY_SUPPLEMENT

Two capsules of Bio Gelee Royale Forte will be taken in the morning on empty stomach once per day for 98 days.

Also known as: Royal Jelly

Bio Gelee Royale Forte

Placebo OTHER

Two capsules of placebo will be taken in the morning on empty stomach once per day for 98 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medex d.o.o.: lead

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

royal jelly

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• David Crowley, PhD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 27, 2024
• Study Start: October 25, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CA (1)