Cognitive ChangeNCT06404203
The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
A study testing Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day, Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day and Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day in people with Cognitive Change and Cytokine Levels, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Cytokine Levels, Neuroinflammation
- What is being tested?
- Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day, Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day and Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 55 and 70,
- Male or female,
Who cannot join
- 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,
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Cognitive Change, Cytokine Levels, Neuroinflammation
- Being tested
- Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day, Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day, Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day, Plasebo
- Keywords
- Cognitive aging, cytokines, neuroinflammation, randomized controlled trial, royal jelly
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Royal Jelly 500 mg | Experimental | 30 volunteer Receives: Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day |
| Royal Jelly 1000 mg | Experimental | 30 volunteer Receives: Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day |
| Royal Jelly 1500 mg | Experimental | 30 volunteer Receives: Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day |
| Placebo | Placebo comparator | 30 volunteer Receives: Other: Plasebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28
Secondary outcomes (12)
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.
Measured: 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.
Measured: Day 28
Serum Interleukin-1β Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: Day 0
Serum Interleukin-1β Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: Day 28
Serum Interleukin-6 Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: Day 0
Serum Interleukin-6 Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: Day 28
Serum Interleukin-10 Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: Day 0
Serum Interleukin-10 Level
Measurement of serum levels will be done with the standard measurement method for the evaluation of inflammatory processes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Jan 2024
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Ali Behesti BAYLAN, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404203
- Sponsor's protocol ID
- E-95961207-604.01.01-5745
- Status last verified
- Oct 2026
- First submitted
- 9 Jul 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06404203
- Acronym / sponsor ID
- E-95961207-604.01.01-5745
- Conditions
- Cognitive Change, Cytokine Levels, Neuroinflammation
- Keywords
- Cognitive aging, cytokines, neuroinflammation, randomized controlled trial, royal jelly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Royal Jelly 500 mg | Experimental | Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day30 volunteer |
| Royal Jelly 1000 mg | Experimental | Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day30 volunteer |
| Royal Jelly 1500 mg | Experimental | Dietary Supplement: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day30 volunteer |
| Placebo | Placebo comparator | Other: Plasebo30 volunteer |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 55 and 70,
- Male or female,
Key exclusion criteria (13 listed)
- History of allergy to bee products
- Known history of lactose allergy
- Diagnosed dementia,
- MMSE score below 21,
- ADAS-Cog score of 12 and above,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/dayVolunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 500 mg/day for 4 weeks. | Dietary supplement | Royal Jelly 500 mg |
| Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/dayVolunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 1000 mg/day for 4 weeks. | Dietary supplement | Royal Jelly 1000 mg |
| Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/dayVolunteers will receive Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement in a dose of 1500 mg/day for 4 weeks. | Dietary supplement | Royal Jelly 1500 mg |
| PlaseboVolunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks. | Other | Placebo |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Geriatric Depression Scale
Time frame: Day 0
Geriatric Depression Scale
Time frame: Day 28
Serum Interleukin-1β Level
Time frame: Day 0
Serum Interleukin-1β Level
Time frame: Day 28
Serum Interleukin-6 Level
Time frame: Day 0
Serum Interleukin-6 Level
Time frame: Day 28
Serum Interleukin-10 Level
Time frame: Day 0
Serum Interleukin-10 Level
Time frame: Day 28
Serum Tumor Necrosis Factor-α Level
Time frame: Day 0
Serum Tumor Necrosis Factor-α Level
Time frame: Day 28
Serum Transforming Growth Factor-β Level
Time frame: Day 0
Serum Transforming Growth Factor-β Level
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day, Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day and Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day in people with Cognitive Change and Cytokine Levels, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.