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

NCT ID: NCT06573814

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-25
• Study Completion Date: 2025-04-01

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.

Conditions

Upper Respiratory Tract Infection; URTI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bio Gelee Royale Forte

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.

Group Type: EXPERIMENTAL

Bio Gelee Royale Forte

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Bio Gelee Royale Forte

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Royal Jelly

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medex d.o.o.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, PhD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Science Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

24MDCFR01

Identifier Type: -

Identifier Source: org_study_id