Clinical trial NCT06404203: The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 55 and 70,
* Male or female,

Exclusion Criteria:

* History of allergy to bee products
* Known history of lactose allergy
* Diagnosed dementia,
* MMSE score below 21,
* ADAS-Cog score of 12 and above,
* Body Mass Index of 35 and above,
* Be taking any medical medication, herbal product or dietary supplement for dementia, except for those who stopped using it at least 1 month before inclusion in our study,
* Being or having been treated for acute acquired brain injuries such as acute traumatic brain injury, acute onset stroke,
* Being followed up due to inflammatory disease,
* Diagnosis of chronic or acute infection,
* Taking corticosteroids or non-steroidal anti-inflammatory drugs,
* Being or having been treated for a psychotic illness,
* Severe anaemia, vital organ dysfunction or critical illness.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: Day 0
measure: Mini-Mental State Examination
timeFrame: Day 28
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale
timeFrame: Day 0
measure: Alzheimer's Disease Assessment Scale-Cognitive subscale
timeFrame: Day 28
measure: Geriatric Depression Scale
timeFrame: Day 0
measure: Geriatric Depression Scale
timeFrame: Day 28
Secondary outcomes:
measure: Serum Interleukin-1β Level
timeFrame: Day 0
measure: Serum Interleukin-1β Level
timeFrame: Day 28
measure: Serum Interleukin-6 Level
timeFrame: Day 0
measure: Serum Interleukin-6 Level
timeFrame: Day 28
measure: Serum Interleukin-10 Level
timeFrame: Day 0
measure: Serum Interleukin-10 Level
timeFrame: Day 28
measure: Serum Tumor Necrosis Factor-α Level
timeFrame: Day 0
measure: Serum Tumor Necrosis Factor-α Level
timeFrame: Day 28
measure: Serum Transforming Growth Factor-β Level
timeFrame: Day 0
measure: Serum Transforming Growth Factor-β Level
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
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