Bio Gelee Royale Forte for Common Cold

Overseen By Erin Lewis, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medex d.o.o.

Must not be taking: Allergy medications

Disqualifiers: Pregnancy, Autoimmune, Respiratory illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Bio Gelee Royale Forte, a royal jelly supplement, can safely and effectively reduce the frequency, severity, and duration of common colds in adults prone to them during cold and flu season. Participants will receive either Bio Gelee Royale Forte or a placebo to compare outcomes. The trial is ideal for generally healthy adults who have experienced at least two colds in the past year and agree to maintain their lifestyle and immune support routines during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial requires participants to maintain their current medications and supplements, especially those used for immunity support, and not add new supplements to their routine.

Is there any evidence suggesting that Bio Gelee Royale Forte is likely to be safe for humans?

Research has shown that royal jelly, the main ingredient in Bio Gelee Royale Forte, is generally safe for use. Bees produce royal jelly, which is rich in nutrients such as proteins and vitamins. Most people tolerate it well, though some may experience mild side effects like an upset stomach or allergic reactions, particularly if they are allergic to bee products. As this is a Phase 2 trial, the treatment has already passed initial safety tests in humans, suggesting it is likely well-tolerated. Always consult a healthcare provider if there are concerns about allergies or side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for the common cold?

Researchers are excited about Bio Gelee Royale Forte because it's derived from royal jelly, a nutrient-rich substance produced by honeybees, which is not typically found in standard cold treatments. While most common cold remedies focus on symptom relief, such as decongestants or antihistamines, this treatment may support the immune system more holistically. The unique aspect of Bio Gelee Royale Forte is its potential to enhance overall immune function, potentially reducing the frequency and severity of colds, which sets it apart from typical treatments that only address symptoms.

What evidence suggests that Bio Gelee Royale Forte might be an effective treatment for the common cold?

Research shows that Bio Gelee Royale Forte, containing royal jelly, might alleviate common cold symptoms. Studies suggest that royal jelly reduces inflammation, potentially easing sore throats and stuffy noses. Known for its health benefits, royal jelly features in many health products. Early findings indicate it might reduce the frequency, severity, and duration of upper respiratory infections in healthy adults. Although more research is needed, these early results are promising for enhancing immune health during cold and flu season. Participants in this trial will receive either Bio Gelee Royale Forte or a placebo to further evaluate its effectiveness. ^{1 2 4 5 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

Healthy adults aged 18-65 who have had at least two upper respiratory tract infections in the past year can join this trial. Women must not be able to bear children, either through surgery or menopause, and all participants agree to use contraception if necessary.

Inclusion Criteria

I am using two forms of birth control.

I use an intrauterine device for contraception.

I am a woman who cannot become pregnant due to surgery or being post-menopausal for over a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Bio Gelee Royale Forte or placebo for 98 days to assess its effects on immune health

14 weeks

Weekly check-ins (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bio Gelee Royale Forte

Trial Overview The study is testing Bio Gelee Royale Forte's effects on immune health by comparing it with a placebo. It looks at how often people get sick, how bad it gets, and how long it lasts during cold season.

How Is the Trial Designed?

Group I: Bio Gelee Royale Forte Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Bio Gelee Royale Forte is already approved in European Union for the following indications:

Approved in European Union as Bio Gelee Royale Forte for:

• Dietary supplement for immune health

Who Is Running the Clinical Trial?

Medex d.o.o.

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

Many dietary supplements claiming to boost the immune system have misleading labels that do not meet FDA standards, raising concerns about their reliability.

Quality control for these supplements is generally inadequate, which could affect their safety and effectiveness for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Supplement Labels May Be Inaccurate and Misleading. Rosenberg, K.[2022]

Health Canada is working to update regulations to allow health claims for functional foods and natural health products (NHPs), recognizing the scientific evidence supporting their health benefits.

Three key initiatives are underway: adopting U.S. health claims in Canada, developing standards for product-specific claims, and creating a regulatory framework for functional foods, which could enhance consumer access to health-related information about these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory issues related to functional foods and natural health products in Canada: possible implications for manufacturers of conjugated linoleic acid. Fitzpatrick, KC.[2023]

Royal jelly, a substance consumed by queen bees, contains health-promoting compounds like 10-hydroxy-2-decenoic acid and major royal jelly proteins, which may have beneficial effects on various disorders including cardiovascular disease and diabetes.

The chapter discusses the potential effects of royal jelly on COVID-19, highlighting its antiviral, anti-inflammatory, and immunomodulatory properties that could be relevant in managing this disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Effect of Royal Jelly on Biomarkers Related to COVID-19 Infection and Severe Progression. Miryan, M., Moradi, S., Soleimani, D., et al.[2023]

Royal jelly (RJ) is a highly nutritious substance with a wide range of health benefits, including anti-inflammatory, antioxidant, antitumor, and antibacterial properties, making it valuable in pharmaceuticals, food, and cosmetics.

The review highlights RJ's potential in treating inflammatory diseases like multiple sclerosis and rheumatoid arthritis, as well as its rich content of bioactive compounds that could enhance human health and warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Insights into Royal Jelly Anti-Inflammatory Properties and Related Diseases. Bagameri, L., Botezan, S., Bobis, O., et al.[2023]

Royal jelly (RJ) has been shown to lower cholesterol levels in mice by decreasing the expression of squalene epoxidase (SQLE), a key enzyme in cholesterol production, and increasing the expression of low-density lipoprotein receptor (LDLR), which helps the liver incorporate cholesterol.

The study utilized a DNA microarray technique to analyze liver gene expression in mice fed diets with 5% RJ, revealing specific molecular mechanisms that contribute to RJ's hypocholesterolaemic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in hepatic gene expression associated with the hypocholesterolaemic activity of royal jelly. Kamakura, M., Moriyama, T., Sakaki, T.[2016]

A total of 94 reports of adverse health events related to red yeast rice (RYR) supplements were analyzed, revealing 187 adverse drug reactions (ADRs), with the most common being musculoskeletal disorders (64 cases) and gastrointestinal issues (33 cases).

The study highlights significant safety concerns regarding RYR supplements, particularly due to the potential serious adverse effects from monacolin K, indicating a need for further research to fully understand their safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb. Vrolijk, MF., van de Koppel, S., van Hunsel, F.[2021]

In a study involving 15 volunteers, those who took 6 g of royal jelly daily for 4 weeks showed significant reductions in serum total cholesterol (TC) and low-density lipoprotein (LDL) compared to a control group.

The decrease in TC and LDL levels is likely due to a reduction in small very-low-density lipoprotein (VLDL) levels, indicating that royal jelly may be beneficial for improving lipoprotein metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Royal jelly supplementation improves lipoprotein metabolism in humans. Guo, H., Saiga, A., Sato, M., et al.[2022]

In a phase 3 clinical trial involving 207 adults, the proprietary extract 7630 from Pelargonium sidoides significantly reduced cold symptoms, with a mean decrease in cold intensity score of 11.2 points compared to 6.3 points in the placebo group by day 5 (P < .0001).

After 10 days, 90.4% of participants treated with 7630 were clinically cured, compared to only 21.2% in the placebo group, indicating that 7630 is an effective and safe treatment for the common cold.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of High-dose Pelargonium Extract in Patients With the Common Cold. Riley, DS., Lizogub, VG., Zimmermann, A., et al.[2022]

In a study involving 400 patients with the common cold, Ganrening Granule (GRN) demonstrated a markedly effective rate of 81.25% and a total effective rate of 96.88%, significantly outperforming the control group.

GRN was particularly effective in reducing fever associated with the common cold, and importantly, no adverse effects were reported during the clinical trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical observation on ganrening granule in treating common cold]. Du, B., Wang, S., Weng, W.[2016]

A combination of 1000 mg of vitamin C and 10 mg of zinc was tested in two double-blind, randomized, placebo-controlled trials involving 94 participants, showing a significant reduction in the duration of rhinorrhea (runny nose) compared to placebo.

The treatment not only provided quicker symptom relief but was also well tolerated, suggesting that vitamin C and zinc supplementation could be an effective and safe option for managing the common cold.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combination of high-dose vitamin C plus zinc for the common cold. Maggini, S., Beveridge, S., Suter, M.[2022]

In a randomized controlled trial with 33 renal cell carcinoma patients, oral intake of royal jelly (RJ) was associated with higher levels of macrophage colony stimulating factor (M-CSF) and lower levels of tumor necrosis factor (TNF)-α, which correlated with reduced anorexia and fatigue during treatment with tyrosine kinase inhibitors (TKIs).

The study suggests that RJ may help mitigate some adverse effects of cancer therapy by modulating inflammation-related factors, particularly M-CSF and transforming growth factor (TGF)-β, with effects varying over the treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying the Inhibition of Tyrosine Kinase Inhibitor-Induced Anorexia and Fatigue by Royal Jelly in Renal Cell Carcinoma Patients and the Correlation between Macrophage Colony Stimulating Factor and Inflammatory Mediators. Yuno, T., Miyata, Y., Mukae, Y., et al.[2020]

A comprehensive postmarketing surveillance (PMS) system was successfully implemented for olestra (Olean), a noncaloric fat substitute, which involved collaboration with snack manufacturers and utilized specialized skills from Consumer Relations and Medical Affairs.

The PMS system effectively managed consumer reports and included a clinical studies program and an independent medical advisory panel, confirming the safety of olestra in savory snacks and providing timely data to the FDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. Slough, CL., Miday, RK., Zorich, NL., et al.[2016]

The EFSA concluded that UV-treated baker's yeast, which contains up to 3.5 million IU of vitamin D per 100 grams, is safe for use in various food products, including yeast-leavened breads and food supplements.

Although the estimated vitamin D intake from this novel food could exceed the upper limit for children aged 4-10 years by 4%, the Panel believes this is unlikely due to conservative intake estimates and the broad range of food categories proposed for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of extended uses of UV-treated baker's yeast as a Novel Food pursuant to Regulation (EU) 2015/2283. Turck, D., Castenmiller, J., De Henauw, S., et al.[2021]

Royal jelly, a substance produced by honeybees, contains various beneficial compounds that may help combat aging-related disorders and improve health, as shown in multiple in vivo and in vitro studies.

It has demonstrated significant physiological effects, including lowering blood pressure, reducing cholesterol levels, and exhibiting antitumor properties, highlighting its potential as a health supplement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Royal jelly: component efficiency, analysis, and standardisation]. Oršolić, N.[2018]

In two randomized, double-blind, placebo-controlled studies involving 130 healthy volunteers, conjugated linoleic acid (CLA) supplementation did not significantly reduce the frequency of colds caused by human rhinovirus (HRV) infection.

While CLA showed some reduction in symptom severity for cough and sore throat in one study, these effects were not consistent across both studies, indicating that larger trials are needed to fully understand CLA's potential impact on HRV-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dietary supplementation with conjugated linoleic acid on experimental human rhinovirus infection and illness. Peterson, KM., O'Shea, M., Stam, W., et al.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06573814?term=Royal%20Jelly&viewType=Table&rank=5

The Effects of Bio Gelee Royale Forte on Immune Health in ... 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 ...

2. withpower.com withpower.com/trial/phase-2-upper-respiratory-tract-infection-9-2024-7947f

Bio Gelee Royale Forte for Common Cold Research on royal jelly, a component of Bio Gelee Royale Forte, shows it can help reduce inflammation, which might be beneficial for common cold symptoms.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06573814/the-effects-of-bio-gelee-royale-forte-on-immune-health-in-healthy-adults

The Effects of Bio Gelee Royale Forte on Immune Health in ... 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 ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-effects-bio-gelee-royale-forte-on-immune-health-healthy-adults-trial-nct06573814

The Effects of Bio Gelee Royale Forte on Immune Health in ... ... jelly supplement, in reducing the frequency, severity, and duration of upper respiratory tract infections (URTIs) in healthy adults during cold and flu season.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172503/

Royal Jelly: Biological Action and Health Benefits - PMC Royal jelly (RJ) is a highly nutritious natural product with great potential for use in medicine, cosmetics, and as a health-promoting food.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-503/royal-jelly

Royal Jelly - Uses, Side Effects, and More Royal jelly is a milky secretion made by worker honeybees (Apis mellifera). It's rich in carbs, protein, amino acids, fatty acids, vitamins, and minerals.