Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 3:04 PM
Study NCT ID:
NCT06404203
Status:
UNKNOWN
Last Update Posted:
2024-05-08
First Post:
2023-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
Sponsor:
Medipol University
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 50-80 years without any neurological disease diagnosis.
Primary outcome measures are the Mini-Mental State Examination, the Alzheimer's Disease Assessment Scale-Cognitive Subscale, and the Geriatric Depression Scale.
Secondary outcome measures are serum interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor-α and transforming growth factor-β levels.
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 50-80 years without any neurological disease diagnosis.
Primary outcome measures are the Mini-Mental State Examination, the Alzheimer's Disease Assessment Scale-Cognitive Subscale, and the Geriatric Depression Scale.
Secondary outcome measures are serum interleukin-1β, interleukin-6, interleukin-10, 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 groups (50-64 years old and 65-80 years old).
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.
Volunteers who meet eligibility criteria will be randomly divided into three groups considering age groups (50-64 years old and 65-80 years old).
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: