Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change of inflammatory transcripton factor
研究概览
简要总结
The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.
详细描述
Royal jelly (RG) is considered a superfood that has been used in traditional medicine and dietary supplementation due to its antioxidant, anti-inflammatory, immunomodulatory, and regenerative properties. The antioxidant and anti-inflammatory effects of GR highlight its potential as a natural supplement for the prevention and management of several health conditions. Although in vitro and animal model data are promising, clinical studies are still needed to validate the effects of royal jelly in human populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stage 1 hypertension
- •Regular treatment for more than 6 months
- •No changes in medication doses during the last 3 months
排除标准
- •Autoimmune diseases
- •Infectious diseases
- •Chronic kidney disease
- •Liver disease
- •Pregnant women
- •Use of catabolic drugs or antibiotics
- •Use of antioxidant vitamin supplements, prebiotics, probiotics, or synbiotics
- •Habitual intake of royal jelly
- •Allergy to bee stings
- •Acute myocardial infarction (AMI)
- •Stroke (CVA)
研究组 & 干预措施
Placebo Group
The placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months.
干预措施: Placebo (Dietary Supplement)
Royal Jelly Group
Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).
干预措施: Royal Jelly (Dietary Supplement)
结局指标
主要结局
Change of inflammatory transcripton factor
时间窗: Baseline and 8 weeks
Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.
次要结局
- Change in interleukin-6 (IL-6) levels(Baseline and 8 weeks)
- Change in Nrf2 expression(Baseline and 8 weeks)
- Change in C-reactive protein (CRP) levels(Baseline and 8 weeks)
- Change in tumor necrosis factor-alpha (TNF-α) levels(Baseline and 8 weeks)
- Change in antioxidant enzyme activity(Baseline and 8 weeks)