Effect of Dietary Flavonoids on Intestinal Microbiota, Intestinal Inflammation and Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fecal calprotectin
研究概览
简要总结
The investigators have hypothesized that dietary flavonoids reduce insulin resistance and subclinical inflammation secondary to reductions in intestinal inflammation and permeability and that these events are mediated through alterations in gut microbiota composition. To test this hypothesis, 30 overweight/obese men and women will be provided two well-controlled diets that are identical in macronutrient content (Protein, 17% en; Fat, 30% en; Carbohydrate, 53% en), but differ markedly in flavonoid content (Low Flavonoid Diet, 10 mg/1000 Kcals; High Flavonoid Diet, 340 mg/1000 Kcals). All meals for both diets will be prepared and fed for 6 weeks each in a randomized cross-over design with endpoints determined in duplicate during the last week of each diet period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •BMI between 25 and 35 kg/m2
排除标准
- •Documented presence of atherosclerotic disease;
- •Diabetes mellitus
- •Uncontrolled hypertension
- •Renal, hepatic, endocrine, gastrointestinal or other systemic disease
- •For women, pregnancy, breast feeding or postpartum < 6 months
- •History of drug or alcohol abuse
- •History of depression or mental illness requiring hospitalization within the last 12 months
- •Use of antibiotics within the last 6 months
- •Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
- •Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
- •Lifestyle or schedule incompatible with the study protocol
- •Other medical, psychiatric, or behavioral conditions that in the view of the principal investigator may present a safety hazard to the participant or interfere with study participation or the ability to follow the intervention protocol.
研究组 & 干预措施
Low Flavonoids then High Flavonoids
Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks.
干预措施: High Dietary Flavonoids (Other)
Low Flavonoids then High Flavonoids
Participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks.
干预措施: Low Dietary Flavonoids (Other)
High Flavonoids then Low Flavonoids
Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks.
干预措施: High Dietary Flavonoids (Other)
High Flavonoids then Low Flavonoids
Participants receive a prepared diet with High Dietary Flavonoids (340 mg of flavonoids/1000 Kcals) for six weeks. After a minimum washout period of 2 weeks, participants receive a prepared diet with Low Dietary Flavonoids (10 mg of flavonoids/1000 Kcals) for six weeks.
干预措施: Low Dietary Flavonoids (Other)
结局指标
主要结局
Fecal calprotectin
时间窗: 6 weeks
Primary endpoint for intestinal inflammation
Serum C-reactive protein
时间窗: 6 weeks
One of two primary endpoints for systemic inflammation
Serum soluble tumor necrosis factor receptor-1
时间窗: 6 weeks
One of two primary endpoints for systemic inflammation
Serum insulin
时间窗: 6 weeks
Primary endpoint for insulin resistance
次要结局
- Serum fasting glucose(6 weeks)
- Calculated Homeostatic Model Assessment-Insulin Resistance(6 weeks)
- Serum C-peptide(6 weeks)
- Plasma lipids(6 weeks)
- Blood pressure(6 weeks)
- Fecal microbiome composition(6 weeks)
- Fecal short chain fatty acids(6 weeks)
- Fecal eosinophil protein X(6 weeks)
- Fecal myeloperoxidase(6 weeks)
- Serum endotoxin(6 weeks)
- Serum interleukin-6(6 weeks)
- Intestinal permeability by four sugar differential absorption test(6 weeks)
- Serum soluble tumor necrosis factor receptor-2(6 weeks)