The Effect of Oral Use of Lyophilised Royal Jelly on Cognitive Functions and Immune System in Elderly Individuals
NCT ID: NCT06404203
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2024-07-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Royal Jelly 500 mg
30 volunteer
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.
Royal Jelly 1000 mg
30 volunteer
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.
Royal Jelly 1500 mg
30 volunteer
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
30 volunteer
Plasebo
Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.
Interventions
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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.
Plasebo
Volunteers will receive a soft vegan gelatin capsule containing lactose in a dose of 1500 mg/day for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Male or female,
Exclusion Criteria
* 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.
55 Years
70 Years
ALL
Yes
Sponsors
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Medipol University
OTHER
Responsible Party
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Muhammet Ali Behesti BAYLAN
Assistant of Principal Investigator
Central Contacts
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Other Identifiers
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E-95961207-604.01.01-5745
Identifier Type: -
Identifier Source: org_study_id
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