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

Medipol University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Interventions

Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/dayDIETARY_SUPPLEMENT

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/dayDIETARY_SUPPLEMENT

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/dayDIETARY_SUPPLEMENT

Volunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 1500 mg/day for 4 weeks.

PlaseboOTHER

Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Mini-Mental State Examination

The Turkish version of Mini-Mental State Examination, which has been tested for validity and reliability, will be administered by the same physician and at the same time interval.

Time frame: Day 0

Mini-Mental State Examination

The Turkish version of Mini-Mental State Examination, which has been tested for validity and reliability, will be administered by the same physician and at the same time interval.

Time frame: Day 28

Alzheimer's Disease Assessment Scale-Cognitive subscale

The Turkish version of Alzheimer's Disease Assessment Scale-Cognitive subscale, which has been tested for validity and reliability, will be administered by the same physician and at the same time interval.

Time frame: Day 0

Alzheimer's Disease Assessment Scale-Cognitive subscale

Time frame: Day 28

Secondary Outcomes

Geriatric Depression Scale

The Turkish version of Geriatric Depression Scale, which has been tested for validity and reliability, will be administered by the same physician and at the same time interval.

Time frame: Day 0

Geriatric Depression Scale

The Turkish version of Geriatric Depression Scale, which has been tested for validity and reliability, will be administered by the same physician and at the same time interval.

Time frame: Day 28

Serum Interleukin-1β Level