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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mini-Mental State Examination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 55 and 70,
- •Male or female,
排除标准
- •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.
研究组 & 干预措施
Royal Jelly 500 mg
30 volunteer
干预措施: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 500 mg/day (Dietary Supplement)
Royal Jelly 1000 mg
30 volunteer
干预措施: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1000 mg/day (Dietary Supplement)
Royal Jelly 1500 mg
30 volunteer
干预措施: Balparmak Apitera Royal Jelly Herbal Capsule Food Supplement 1500 mg/day (Dietary Supplement)
Placebo
30 volunteer
干预措施: Plasebo (Other)
结局指标
主要结局
Mini-Mental State Examination
时间窗: 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
时间窗: 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.
Mini-Mental State Examination
时间窗: 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.
Alzheimer's Disease Assessment Scale-Cognitive subscale
时间窗: 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.
次要结局
- Serum Interleukin-10 Level(Day 28)
- Serum Tumor Necrosis Factor-α Level(Day 28)
- Serum Interleukin-1β Level(Day 28)
- Serum Transforming Growth Factor-β Level(Day 28)
- Serum Interleukin-6 Level(Day 28)
- Geriatric Depression Scale(Day 0)
- Geriatric Depression Scale(Day 28)
- Serum Interleukin-1β Level(Day 0)
- Serum Interleukin-6 Level(Day 0)
- Serum Interleukin-10 Level(Day 0)
- Serum Tumor Necrosis Factor-α Level(Day 0)
- Serum Transforming Growth Factor-β Level(Day 0)
研究者
Muhammet Ali Behesti BAYLAN
Assistant of Principal Investigator
Medipol University