Effects of Almond Consumption on Innate Myeloid and Lymphoid Cells Composition and Activity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Changes in innate myeloid and lymphoid cells
研究概览
简要总结
Almonds are a rich matrix of different nutrients with demonstrated benefits on immune system. This proposal examines the effect of regular consumption of almonds on innate and adaptive immune system in healthy individuals with overweight regularly consuming a Western-style diet and unhealthy snacks.
详细描述
In the last months, with the whole world grappling with COVID-19 and because like in many other diseases, the host immune system determines the progress of COVID-19 and the severity, there is a frantic race for finding treatment strategies based on current knowledge until effective vaccine is developed. Therefore, the modulation of inflammatory response and cytokine production using immunonutrition makes more sense than ever.
The almond is a tree nut, rich in fiber, vitamin E, biotin, minerals such as magnesium and phytonutrients, specifically flavonoids, plant sterols, phenolic acids and could have a potential beneficial role in immune system. However, beyond its beneficial role and down-lowering specific circulating cytokines in low-grade chronic inflammatory diseases, the role of almond on both innate and adaptive immune system has not been explored.
The investigators hypothesize that regular consumption of almonds will contribute to strengthening the immune system through the modulation of specific circulating miRNAs.
The primary objective is to evaluate the effect of almond consumption on the maturation of innate lymphoid cells (ILCs).
Secondarily, the insvestigators aims to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25.0-34.9 Kg/m2
- •Western-style diet
- •Unhealthy snacks other than nuts (i.e. potato chips, crackers, corn puffs, pretzels, pastries, cookies, candies) >1 serving/day
排除标准
- •Regular smokers (≥ 10 cigarettes/day)
- •Diagnoses of type 2 diabetes
- •Cardiovascular disease, chronic kidney disease, liver disease, active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption, cancer - active malignant cancer or history of malignancy within the last 5 years, psychiatric disorders
- •Use of anti-inflammatory or antioxidants drugs
- •Not stable medication in the last 3 months
- •Regular alcohol consumption above of the national recommendations or drug abuse
- •Frequent consumption of nuts
- •Allergy to the intervention products or other severe allergies and food intolerances
- •Dietary patterns interfering with the study protocol (e.g. vegetarian, vegan, low carbohydrate dieters, high fat dieters) two months prior inclusion, during the study or plans to initiate during the study
- •Daily use of multivitamin or mineral supplements
- •Bad dentures, implying difficulty to chew nut
- •Pregnancy or lactation, pregnancy within the past 12 month or plans to become pregnant during the study
- •Consumption of probiotics or prebiotics in the last 3 months and laxatives
结局指标
主要结局
Changes in innate myeloid and lymphoid cells
时间窗: These outcomes will be assessed at baseline and at 8 weeks
CD45+, CD103+, CD56+, CD14+,CD16+, CD8+, CD19+, CD4+, CD3+, CD36+, CD44+, ROR γ t, NKp46+, FoxP3+ will be assessed by means of flow cytometry in cryopreserved cells.
次要结局
- Changes in immune cells activity assessed by adaptor molecules(These outcomes will be assessed at baseline and at 8 weeks)
- Changes in inflammatory markers and related molecules in plasma/serum(These outcomes will be assessed at baseline and at 8 weeks)
- Changes in lymphocyte subsets(These outcomes will be assessed at baseline and at 8 weeks)
- Changes in immune cells activity assessed by citokyne production(These outcomes will be assessed at baseline and at 8 weeks)