Breakfast for Young Females - the Importance of Breakfast Type
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in Fat mass in grams
研究概览
简要总结
Investigators will test the health effects of eating a dairy-based protein-rich breakfast or isocaloric breakfast and performing regular physical exercise training for 12 weeks in young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces and urine metabolites, and food diary will be collected.
详细描述
The study is a 2×2-factorial randomized controlled trial with 4 study arms. One-hundred (100) subjects will be randomly allocated to eat breakfast consisting of high-protein yoghurt (300g/day) with oats or an isocaloric breakfast consisting of bread, jam and juice matched for fat and fiber content and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline, half way (some parameters only) and at the end of the intervention period.
The primary outcome will be fat mass and fat free mass determined by DXA. The investigators will also measure effects on weight, waist, health-related blood parameters, muscle function, physical activity, habitual food intake and metabolites in faeces, urine and blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index > 25
- •Regular exercise < 1 hour per week
排除标准
- •illness and use of medication affecting the study outcomes
- •allergy towards milk and yoghurt
- •weightloss/gain >5kg the last 6 months
- •eating disorder
- •pregnancy
- •breast feeding
- •unable to speak and understand danish
结局指标
主要结局
Change in Fat mass in grams
时间窗: 12 weeks
Measured by dual energy x-ray absorptiometry (DXA)
次要结局
- Change in glucose(12 weeks)
- Change in glucose peak(12 weeks)
- Change in glucose tolerance (area under the curve)(12 weeks)
- Change in weight (kg)(12 weeks)
- Change in high density lipoprotein cholesterol (HDL cholesterol)(12 weeks)
- Change in maximal hand grip strength(12 weeks)
- Change in Fat free mass in grams(12 weeks)
- Change in Lean body mass in grams(12 weeks)
- Change in BMI (m^2/kg)(12 weeks)
- Change in HbA1c(12 weeks)
- Change in triacylglycerol (TG)(12 weeks)
- Change in insulin(12 weeks)
- Change in fitness (estimated VO2-max)(12 weeks)
- Change in systolic and diastolic blood pressure(12 weeks)
- Change in Waist circumference (cm)(12 weeks)
- Change in Height (cm)(12 weeks)
- Change in maximal arm strength(12 weeks)
- Change in maximal jump height(12 weeks)
- Change in low density lipoprotein cholesterol (LDL cholesterol)(12 weeks)
- Change in total cholesterol(12 weeks)