NCT06404203

The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals

Investigation of the Effect of Oral Use of Lyophilised Royal Jelly (Apis Mellifera) on Cognitive Functions and Inflammation-Related Immune System Cytokine Levels in Elderly Individuals: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Dementia is a significant public health problem, affecting 47 million people worldwide in 2015, according to World Health Organization data. It is expected to increase to 75 million in 2030 and reach 132 million in 2050. Royal jelly is used as a supplement in treating of cancer, hypertension, diabetes and neurodegenerative diseases due to its antioxidant, anti-inflammatory, neuroprotective, cardioprotective, anti-proliferative and anti-fatigue properties. There are preclinical studies on the curative and protective effects of royal jelly on cognitive functions. This randomized controlled, double-blind clinical trial is aimed to study the effect of oral use of lyophilized royal jelly for 4 weeks on immune system cytokine levels and cognitive functions in individuals aged 55-70 years without any neurological disease diagnosis. Primary outcome measures are the Mini-Mental State Examination, and the Alzheimer's Disease Assessment Scale-Cognitive Subscale. Secondary outcome measures are the Geriatric Depression Scale, and serum interleukin-1β, and interleukin-6, and interleukin-10, and tumor necrosis factor-α, and transforming growth factor-β levels.

Detailed description

Volunteers who apply to Bağcılar Medipol Mega University Hospital Neurology Polyclinic will be recruited, and their demographic information will be recorded. Volunteers who meet eligibility criteria will be randomly divided into three groups considering age, and gender, and BMI, and education level . Primary and secondary outcome measures will be evaluated in volunteers. The results obtained will be recorded. Diet recommendations will be made to the volunteers for four weeks. The products detailed in the protocol will be used by the volunteers orally for four weeks on an empty stomach in the morning. Primary and secondary outcome measures will be reassessed in volunteers on day 28. The results obtained will be recorded. Obtained results will be evaluated statistically.

Conditions

• Cognitive Change
• Cytokine Levels
• Neuroinflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day	Volunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 500 mg/day for 4 weeks.
DIETARY_SUPPLEMENT	Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day	Volunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 1000 mg/day for 4 weeks.
DIETARY_SUPPLEMENT	Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day	Volunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 1500 mg/day for 4 weeks.
OTHER	Plasebo	Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-01-10
• Completion: 2026-01-15
• First posted: 2024-05-08
• Last updated: 2026-03-16

Locations

1 site across 1 country: Turkey (Türkiye)