Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change from Baseline Serum LDL Cholesterol at 8 weeks
研究概览
简要总结
The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.
详细描述
The investigators will conduct a randomized, double-blind, controlled, parallel, intervention study in dyslipidemic adults with abdominal obesity (n = 130). Participants will consume either a control dairy beverage (n = 65) or an MPL-rich dairy beverage (n = 65) for 8 weeks. The investigators plan to evaluate the following 4 specific objectives:
- Determine the effects of MPLs on serum lipid concentrations and other cardiometabolic risk factors.
- Evaluate the effects of MPLs on systemic biomarkers of low-grade inflammation.
- Examine the effects of MPLs on lipoprotein metabolism and lipoprotein particle characteristics.
- Evaluate the effects of MPLs on gut microbiota, gut permeability markers, and fecal lipids.
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
- Double (Participant, Investigator)
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
- •LDL-C ≥ 130 mg/dL
- •Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
- •Aged 18 to 70 years
排除标准
- •Renal disease
- •Liver disease
- •Heart disease
- •Eating disorders
- •Thyroid disease
- •Gut-associated pathologies
- •Autoimmune diseases
- •Chronic inflammatory diseases
- •Scleroderma
- •Gallbladder disease
- •Blood clotting disorders
- •Intravenous drug use
- •Fasting plasma/serum triglycerides >500 mg/dL
- •Fasting plasma/serum glucose >126 mg/d
- •Weight changes >10% over last 4 weeks
- •Oral antibiotics use up to 1 month prior to and during study
- •Allergy or intolerance to milk products
- •Taking lipid-lowering medications (e.g., statins, fibrates)
- •Taking anti-inflammatory medications (e.g., corticosteroids)
- •Taking medications which primarily affect blood clotting (e.g., warfarin).
研究组 & 干预措施
Control dairy powder
Daily consumption of 50 g of dairy powder containing <0.1 g MPL for 8 weeks
干预措施: Dairy Powder (Dietary Supplement)
MPL-rich dairy powder
Daily consumption of 50 g of dairy powder containing 6.5 g MPL for 8 weeks.
干预措施: Milk Polar Lipid-Rich Dairy Powder (Drug)
结局指标
主要结局
Change from Baseline Serum LDL Cholesterol at 8 weeks
时间窗: 8 weeks
Measurement of serum LDL cholesterol (mg/dL) at the beginning and end of 8-week intervention arm.
次要结局
未报告次要终点
研究者
Christopher Blesso
Associate Professor
University of Connecticut