Effect of High Cheese Consumption on Metabolic Syndrome Risk Factors in a Metabolically Vulnerable Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Changes in LDL cholesterol from baseline to post-intervention
研究概览
简要总结
The overall aim of the present research project is to examine whether consumption of high daily amounts of cheese, both high-fat and low-fat, affects risk markers of disease in a study population of men and women with metabolic syndrome risk factors.
It will be explored whether high-fat and/or low-fat cheese consumption can be regarded healthy to consume for at-risk populations (assessed by within-group comparisons from baseline values) and if low-fat or non-fat alternatives to high-fat cheese should continue to be recommended (assessed by between-group comparisons).
In addition, it will be assessed if cheese consumption affects women and men differently as suggested by observational data. The present research project will examine the health effects of cheese as a food product per se and not as a sum of single nutrients, knowing that the single components of cheese cannot be adequately placebo-matched. A relatively high daily intake of high-fat cheese will be compared to a similar intake of low-fat cheese and with a carbohydrate control.
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
- None
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
- •Men or women
- •Waist circumference > 80 cm for women / > 94 cm for men
- •Plus at least one additional established risk factor for the metabolic syndrome using the following criteria:
- •Elevated BP (Systolic BP > 130 mmHg and/or diastolic BP > 85 mmHg);
- •Elevated triglycerides (>1.7 mmol/l);
- •Reduced HDL-C (<1.0 mmol/l for men and < 1.3 mmol/l for women);
- •Elevated fasting glucose (> 5.6 mmol/l). BMI 18.5 - 35 kg/m2
排除标准
- •Chronic diseases (known diabetes; cardiovascular disease; other chronic diseases which could affect the results of the present study)
- •Milk allergy
- •Use of dietary supplements incl. multivitamins (2 months before and during the entire study period)
- •>10 hours of strenuous physical activity per week
- •Use of prescription medicine which could affect the results of the present study including systemic glucocorticoids or medicine which have interactions with the intervention products (safety)
- •Drug or alcohol abuse
- •Blood donation <1 month before study commencement and during study period
- •Simultaneous participation in other clinical studies
- •Pregnant or lactating women, or women who are planning to become pregnant within the next 6 months.
- •Inability to comply with the procedures required by the protocol
研究组 & 干预措施
High-fat cheese (HFC) group
The subjects in the HFC group will be supplied with equal amounts of two types of regular/high fat cheeses. The cheeses are normal-fat Danbo (Riberhus, 25% fat, Arla, DK) and normal-fat Cheddar (Sharp Cheddar, 32% fat, Cabot, US).
No further dairy and cheese consumption is allowed
干预措施: High-fat cheese (Dietary Supplement)
Low-fat cheese (LFC) group
The subjects in the LFC group will be supplied with equal amounts of two types of reduced/low fat cheeses. The cheeses are reduced-fat Danbo(Cheasy, 13% fat, Arla, DK) and reduced-fat Cheddar (Sharp Light Cheddar, 16% fat, Cabot, US). No further dairy/cheese consumption is allowed.
干预措施: Low-fat cheese (Dietary Supplement)
No-cheese/carbohydrate group (CTR)
For subjects in the CTR group, cheese is replaced by simple and starchy carbohydrates in jam and white bread, which will be supplied by the department. The daily energy and sodium contents will be matched to those of the cheese in the HFC group. No dairy/cheese consumption is allowed.
干预措施: No-cheese/carbohydrate (Dietary Supplement)
结局指标
主要结局
Changes in LDL cholesterol from baseline to post-intervention
时间窗: week 1 and week 12
fasting, mmol/l
次要结局
- Particle size(week 1 and week 12)
- Blood lipid concentrations(week 1 and week 12)
- Anthropometry(5 times during the 12-week intervention)
- Postprandial markers of lipid metabolism(week 12)
- Blood pressure (BP)(3 time during the 12-week intervention)
- Insulin sensitivity(week 1 and week 12)
- Inflammation(week 1 and week 12)
- Postprandial markers of glucose metabolism(week 12)
- Postprandial appetite sensation (by VAS)(week 12)
研究者
Arne Astrup
Prof., MD, Head of Department, Department of Nutrition, Exercise and Sports
University of Copenhagen