Effect of Prebiotic Fibre and Polyunsaturated Fatty Acid (PUFA) on the Gut Microbiota and Metabolic Risk Markers in a Metabolically Challenged Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in gut microbiota composition
研究概览
简要总结
The main objective of this study is to investigate in detail how a high-(prebiotic)fibre diet and a high-PUFA diet affect the gut microbiota composition in a metabolic challenged population, and if the diet-induced modulation of the gut microbiota mediates changes in metabolic risk markers.
Intake of both experimental diets over 4 weeks are expected to induce beneficial changes in the gut microbiota composition and to affect markers for insulin sensitivity, lipid metabolism and inflammation. The investigators hypothesize that the effect of both interventions on the metabolic risk markers will be partly mediated by the diet-induced changes in the gut microbiota composition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI: 25-40 kg/m2
- •Non-smoking
- •Indices of the Metabolic Syndrome defined by the International Diabetes Federation (IDF 2006):
- •Central obesity (waist circumference; men: ≥94 cm and women: ≥80 cm) + any one of the following; raised triglyceride level (≥1.7 mmol/L), reduced HDL cholesterol (men: <1.03 mmol/L, women: <1.29 mmol/L), raised BP (systolic ≥130 mm Hg or diastolic ≥85 mm Hg) or raised fasting plasma glucose (≥5.6 mmol/L).
排除标准
- •Use of antibiotics
- •Weight change >3 kg 2 months prior to study start
- •Intensive physical training/ elite athlete
- •Medication for dyslipidemia, type 2 diabetes or elevated blood pressure
- •Dietary supplements with pro/prebiotics, dietary fibre or fish oil supplement
- •Lactation, pregnancy or planning of pregnancy during the study
- •Gastro intestinal and liver disorders
- •Chronic inflammatory disorders
- •Diagnosed psychiatric disorder including treatment required depression
- •Surgical treatment of obesity and abdominal surgery
结局指标
主要结局
Change in gut microbiota composition
时间窗: Week 0, 4, 8, 12
Gut microbiota composition will be analyzed by use of fecal samples.
次要结局
- Faecal SCFA and bile acid composition(Week 0, 4, 8, 12)
- Change in markers for lipid metabolism(Week 0, 4, 8, 12)
- Change in markers for insulin sensitivity(Week 0, 4, 8, 12)
- Change in markers for inflammation(Week 0, 4, 8, 12)
- Lipidomics(Week 0, 4, 8, 12)
- Metabolomics(Week 0, 4, 8, 12)
研究者
Arne Astrup
Professor, Dr.Med.
University of Copenhagen