Dairy Lipids, Proteins, and the Metabolic Syndrome - "DairyHealth"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Postprandial triglyceride response
研究概览
简要总结
Dairy food contains a large amount of long-chain saturated fat, which traditionally has been linked to increased risk of cardiovascular disease (CVD). However, recent data indicates a more neutral role. Milk fat contains large amounts of medium-chain saturated fatty acids (MC-SFA), which may have beneficial effects on human health. In addition, milk proteins and in particular whey proteins have been shown to have a beneficial effect on glucose disposal as well as anti-inflammatory properties. Therefore dairy products have a potential role in the treatment of the metabolic abnormalities of metabolic syndrome (MeS). However, human data from intervention studies are lacking.
Aims of this project is to explore and understand the influence on human health of both medium-chain saturated fatty acids from milk fat and bioactive milk proteins per se as well as their interaction and potential positive synergy on the MeS.
The investigators hypothesize that whey protein and medium-chain saturated fatty acids improve insulin sensitivity, postprandial lipid metabolism, blood pressure and inflammatory stress in humans and that they possess preventive effects on the risk of developing CVD and type 2 diabetes mellitus (T2DM).
A total of 64 people with MeS or abdominal obesity will be included. The design is a randomized double-blinded, controlled parallel diet-intervention trial.
Subjects are assigned one of four experimental diets for 12 weeks. The diets consist of either a diet with low levels of MC-SFA + whey protein (LF + whey), a diet high in MC-SFA + whey protein (HF + whey), a diet high in MC-SFA + casein protein (HF + casein) or a diets with low levels of MC-SFA + casein protein (LF + casein). The subjects are advised how to integrate the test foods in their habitual diet, which also continues unchanged. The subjects' energy intake is matched so they are kept weight stable throughout the study.
详细描述
See above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic syndrome
- •Central obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
- •with two or more of the following
- •Fasting triglyceride > 1.7 mmol/l
- •HDL-cholesterol; male < 1.03 mmol/l, female < 1.29 mmol/l
- •BP ≥ 130/85
- •Fasting plasma glucose ≥ 5,6 mmol/l (but not diabetes)
- •Or abdominal obesity (Waist: female ≥ 80 cm; male ≥ 94 cm)
排除标准
- •Significant cardiovascular, renal or endocrine disease
- •Psychiatric history
- •Treatment with steroids
- •Alcohol- or drug-addiction
- •Pregnancy or lactation
结局指标
主要结局
Postprandial triglyceride response
时间窗: Change from week 0 to week 12
Compare the changes in mean difference of 6 hours incremental area under the curve (iAUC) (week 12 - week 0) between the groups and the intervention components.
次要结局
- 24 hour blood pressure (BP)(Change from week 0 to week 12)
- Indirect calorimetry(Change from week 0 to week 12)
- Dexa-scan (body composition)(Change from week 0 to week 12)
- Weight(Change from week 0 to week 12)
- Biomarkers in blood samples(Change from week 0 to week 12)
- Waist and hip circumference(Change from week 0 to week 12)
- Fat tissue biopsy(Change from week 0 to week 12)
- Biomarkers in urine(Change from week 0 to week 12)
- Glucose tolerance(Change from week 0 to week 12)
- Dietary compliance(Change from week 0 to week 12)
- Postprandial apolipoprotein-48 (apoB-48), 6 hour(Change from week 0 to week 12)