Prebiotic Supplementation and Metabolic Endotoxemia and Modulation of the Gut Microbiota: Double-blind and Randomized Parallel Clinical Study of the Efficacy and Synergistical Effect of Cranberry Polyphenols and Inulin From Agaves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
研究概览
简要总结
The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
详细描述
It is now recognized that overweight individuals have altered microbiota which could lead to intestinal barrier defects and chronic inflammation disorders. Polyphenols such as Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable bacteria in the gut.
The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from cranberry extract with or without a supplement of inulin from agaves to reduce chronic inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight (BMI 25-39.9 kg/m2) or waist circumference ≥ 80 cm (women) and ≥94 cm (men)
- •fasting insulin over 60 pmol/L or fasting glucose 5.6 - 6.9 mmol/L
- •at least one of the following criteria: Tg ≥ 1.7 mmol/L; blood pressure ≥ 130/85 mmHg; HDL < 0,9 mmol/L; hsCRP 1-10 mg/L
- •non-smoking
- •eating fruits and vegetables less then 5 portions/day
排除标准
- •chronic disease
- •taking drugs or natural health products that could affect glucose or lipid metabolism
- •taking anti-inflammatory, antiacids
- •taking pre or probiotics
- •inflammatory bowel disease
- •antibiotics in the past 3 months
- •allergy or intolerance to cranberries or agaves
- •Major surgery in the past 3 months
结局指标
主要结局
Change in metabolic endotoxemia: Measure concentration of Lipopolysaccharides (LPS) and Lipopolysaccharide Binding Protein (LBP) in plasma
时间窗: At the beginning and the end of treatment (10 weeks)
effect of the supplements on variation in plasma concentration of LPS and LBP
次要结局
- Change in intestinal permeability: Measure concentration of zonulin in plasma(At the beginning and the end of treatment (10 weeks))
- Change in microbiota diversity: growth of Akkermancia muciniphila, Lactobacillus, Prevotella, Bifdobacterium and inhibition of Clostridium perfringens, C. difficile, Bacteroides spp.)(At the beginning and the end of treatment (10 weeks))
- Change in inflammation state of the tissue: Measure concentration of calprotectin and lactoferrin in feces(At the beginning and the end of treatment (10 weeks))
- Change in systemic inflammation: Measure concentration of inflammation biomarkers in the serum(At the beginning and the end of treatment (10 weeks))
- Change in glucose serum concentration(At the beginning and the end of treatment (10 weeks))
- Change in insulin and C-peptide serum concentration(At the beginning and the end of treatment (10 weeks))