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

Cognitive Change Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404203
• Other study ID #: E-95961207-604.01.01-5745
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: Medipol University
• Contact: Muhammet AB Baylan, MD
• Phone: +90 (530) 694 74 25
• Email: muhammet.baylan[@]std.medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Dietary Supplement:
• 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 10000 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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	Day 28
Primary	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.	Day 0
Primary	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.	Day 28
Primary	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.	Day 0
Primary	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.	Day 28
Secondary	Serum Interleukin-1ß Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Secondary	Serum Interleukin-1ß Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Secondary	Serum Interleukin-6 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Secondary	Serum Interleukin-6 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Secondary	Serum Interleukin-10 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Secondary	Serum Interleukin-10 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Secondary	Serum Tumor Necrosis Factor-a Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Secondary	Serum Tumor Necrosis Factor-a Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Secondary	Serum Transforming Growth Factor-ß Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Secondary	Serum Transforming Growth Factor-ß Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28