Breakfast for Female Adolescent - NewStart
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Body composition (DXA scan) 1
研究概览
简要总结
Investigators will test the long-term health effects of eating a dairy-based protein-rich breakfast and/or performing regular physical training for 12 weeks in 100 previous 'breakfast skipping' young overweight women (2 x 2 factorial design). Measurements of body composition, physical fitness, metabolic health parameters, faeces (microbiota activity and composition), satiety and daily energy intake will be collected.
详细描述
The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to skip breakfast or eat high-protein yoghurt products (300g/day) and to either exercise 3x per week or maintain habitual physical activity for 12 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention period.
The primary outcome will be fat mass and fat free mass. The investigators will also measure effects on weigth, waiste, health-related blood paramenters, muscle function, metabolites in urine and blood, and gut microflora and pH.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •exercising < 1 h 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
Body composition (DXA scan) 1
时间窗: 12 weeks
Fat mass in grams
Body composition (DXA scan) 2
时间窗: 12 weeks
Fat free mass in grams
次要结局
- Height(12 weeks)
- Feaces pH(12 weeks)
- Blood metabolites(12 weeks)
- Urine metabolites(12 weeks)
- LDL(12 weeks)
- Fitness(12 weeks)
- BMI(12 weeks)
- HbA1c(12 weeks)
- HDL(12 weeks)
- Muscle strength(12 weeks)
- maximal jump height(12 weeks)
- weight(12 weeks)
- Health related blood parameter 1(12 weeks)
- Health related blood parameter 2(12 weeks)
- Health related parameter(12 weeks)
- Food log(12 weeks)
- Gut microflora(12 weeks)
研究者
Mette Hansen
Associate professor
University of Aarhus