A Blinded Placebo-controlled Human Pilot Study for the Investigation of the Role of Bilberry and Olive Bioactives on Oxidative Stress Parameters and Inflammatory Markers. Relevance in European Population
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Numerous plant-based foods contain bioactive compounds, in particular polyphenols, which have antioxidant, anti-inflammatory, and metabolic regulatory effects. These so-called food bioactives (FB) are converted in the human organism, in particular by the gut microbiota and microsomal (liver/intestinal) metabolism, into numerous metabolites, which often represent the actual biologically active molecules. As part of the European HORIZON-MSCA Doctoral Network "BioTransform," two such food models are being studied as examples: 1. Olive products (Olea europaea L.) - representative of the Mediterranean diet, rich in secoiridoids and phenylethanols (especially hydroxytyrosol and tyrosol). 2.
Bilberry /blueberry (Vaccinium myrtillus L.) - representative of the Central European diet, rich in anthocyanosides. Two parallel human intervention studies will be conducted, one in Graz (WP1, DC5) and one in Athens (WP1, DC3). These pilot studies will generate biological samples (blood, urine, stool) and investigate the extent to which taking these standardized dietary supplements influences glucose metabolism and markers of oxidative stress and low-grade inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-50 years old,
- •BMI> 25 kg/m2
- •prediabetic stage
- •hsCRP> 2mg/ L
- •HbA1c 5,7-6,4%
- •Impaired fasting glucose (IFG)
- •Caucasian
排除标准
- •No signed informed consent
- •Supplementation or probiotic usage in the past 8 weeks
- •Chronic gastrointestinal, inflammatory or metabolic diseases
- •Alcohol misuse
- •Pregnancy or breastfeeding
- •Acute infection during the past month
研究组 & 干预措施
INTERVENTION WITH OLIVE OIL EXTRACTS
Group of 20 people will receive olive oil extract supplements and after the washout period will receive placebo.
干预措施: supplementation, food (Dietary Supplement)
INTERVENTION WITH BILBERRY
Group of 20 participants will receive bilberry extract supplements and after the washout period a placebo phase.
干预措施: supplementation, food (Dietary Supplement)
研究者
Nikolaos Tentolouris
Professor of Medicine
National and Kapodistrian University of Athens
