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

Medex d.o.o.

Status and phase: Completed; Phase 2

Conditions: Upper Respiratory Tract Infection; URTI

Treatments: Dietary Supplement: Bio Gelee Royale Forte; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06573814

24MDCFR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups, including a placebo group

Bio Gelee Royale Forte

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Bio Gelee Royale Forte

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo