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Completed

NCT Number: NCT06404203

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

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.

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Key information

Conditions

Cognitive Change Cytokine Levels Inflammation Nervous System Diseases Neuroinflammation Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

T.C. Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Dietary 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/day

Dietary 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/day

Dietary Supplement

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

Plasebo

Other

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

Primary outcomes

  1. Mini-Mental State Examination

    Time frame: Day 0

    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.

  2. Mini-Mental State Examination

    Time frame: Day 28

    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.

  3. Alzheimer's Disease Assessment Scale-Cognitive subscale

    Time frame: Day 0

    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.

  4. Alzheimer's Disease Assessment Scale-Cognitive subscale

    Time frame: Day 28

    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.

Secondary outcomes

  1. Geriatric Depression Scale

    Time frame: Day 0

    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.

  2. Geriatric Depression Scale

    Time frame: Day 28

    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.

  3. Serum Interleukin-1β Level

    Time frame: Day 0

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  4. Serum Interleukin-1β Level

    Time frame: Day 28

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  5. Serum Interleukin-6 Level

    Time frame: Day 0

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  6. Serum Interleukin-6 Level

    Time frame: Day 28

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  7. Serum Interleukin-10 Level

    Time frame: Day 0

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  8. Serum Interleukin-10 Level

    Time frame: Day 28

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  9. Serum Tumor Necrosis Factor-α Level

    Time frame: Day 0

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  10. Serum Tumor Necrosis Factor-α Level

    Time frame: Day 28

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  11. Serum Transforming Growth Factor-β Level

    Time frame: Day 0

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

  12. Serum Transforming Growth Factor-β Level

    Time frame: Day 28

    Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 8, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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