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

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Neuroinflammation; Cytokine Levels
• Intervention / Treatment: Dietary supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day; Dietary supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day; Other: Plasebo; Dietary supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day

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, 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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • T.C. Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Royal Jelly 500 mg; 30 volunteer	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.
Experimental: Royal Jelly 1000 mg; 30 volunteer	Dietary supplement: 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 1000 mg/day for 4 weeks.
Experimental: Royal Jelly 1500 mg; 30 volunteer	Dietary supplement: 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.
Placebo Comparator: Placebo; 30 volunteer	Other: Plasebo; Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Serum Interleukin-1β Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Serum Interleukin-1β Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Serum Interleukin-6 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Serum Interleukin-6 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Serum Interleukin-10 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Serum Interleukin-10 Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Serum Tumor Necrosis Factor-α Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Serum Tumor Necrosis Factor-α Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28
Serum Transforming Growth Factor-β Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 0
Serum Transforming Growth Factor-β Level	Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.	Day 28

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): January 10, 2026
• Study Completion (Actual): January 15, 2026

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; cytokines; neuroinflammation; Cognitive aging; royal jelly
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Inflammation; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: E-95961207-604.01.01-5745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No