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The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
Sponsor: Medipol University
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-01-15
Completion Date
2026-01-15
Last Updated
2026-10-26
Healthy Volunteers
Yes
Interventions
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.
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.
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.
Plasebo
Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.
Locations (1)
T.C. Istanbul Medipol University
Istanbul, Turkey (Türkiye)