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

NCT06404203 | Completed DMC

• 1 other identifier: E-95961207-604.01.01-5745
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cognitive Change; Cytokine Levels; Neuroinflammation

Keywords

Cognitive aging; cytokines; neuroinflammation; randomized controlled trial; royal jelly

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Geriatric Depression Scale

  Day 0

• Geriatric Depression Scale

  Day 28

• Serum Interleukin-1β Level

  Day 0

• Serum Interleukin-1β Level

  Day 28

• Serum Interleukin-6 Level

  Day 0

Study Arms (4)

Royal Jelly 500 mg

EXPERIMENTAL

30 volunteer

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

Royal Jelly 1000 mg

EXPERIMENTAL

30 volunteer

Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day

Royal Jelly 1500 mg

EXPERIMENTAL

30 volunteer

Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day

Placebo

PLACEBO COMPARATOR

30 volunteer

Other: Plasebo

Interventions

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.

Royal Jelly 1000 mg

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.

Royal Jelly 1500 mg

Plasebo OTHER

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

Placebo

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.

Royal Jelly 500 mg

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

T.C. Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuroinflammatory Diseases

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employed a rigorous quadruple-blind design, successfully blinding 120 participants, clinicians, laboratory personnel, and statisticians to systematically isolate bias. To prevent unblinding from the active supplement's (LRJ) distinct organoleptic properties, strict masking was applied; active and placebo capsules were manufactured to be identical in appearance, weight, and texture. Additionally, daily capsule counts and administration timings were standardized across all dose groups to prevent dosage guessing. Allocation codes were strictly concealed until database lock and completion of primary analyses, minimizing observer bias. An emergency code-breaking protocol was established but remained unused. Collectively, these stringent procedures ensured high internal validity and methodological robustness.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of Principal Investigator

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: May 8, 2024
• Study Start: July 1, 2024
• Primary Completion: January 10, 2026
• Study Completion: January 15, 2026
• Last Updated: March 16, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)