NCT06573814

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

A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy of Bio Gelee Royale Forte on Immune Health in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medex d.o.o. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
OTHER	Placebo	Two capsules of placebo will be taken in the morning on empty stomach once per day for 98 days.

Timeline

• Start date: 2024-10-25
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-08-27
• Last updated: 2025-04-29

Locations

1 site across 1 country: Canada