Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-07-09
Brief Title:
The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
Sponsor:
Medipol University
Organization:
Medipol University
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
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 Alzheimers 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 Alzheimers 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:
None
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?:
None