Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- ad libitum energy intake
研究概览
简要总结
Aim of the study is to investigate the effects of high-protein, ultraprocessed foods on the regulation of energy balance in a metabolic chamber. The primary outcome parameter of the study is the energy balance (ad libitum energy intake and energy expenditure).
详细描述
Each of the two study weeks starts with a 3-day run-in period with controlled diet at home, following 48 hours in a metabolic chamber. On the day the participants leave the metabolic chamber, they keep a food record over the rest of the day at home.
- week: meals containing 30 % protein (80 % ultraprocessed high-protein foods), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake
- week: meals containing 13 % protein (80 % ultraprocessed foods with moderate protein content), physical activity level (PAL) 1.45, 2 intervention days in the metabolic chamber: ad libitum energy intake
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 19-29 kg/m2
- •low-medium habitual physical activity
- •women with regular menstrual cycle (during intervention in follicular phase)
排除标准
- •chronic illnesses (e.g. renal dysfunction)
- •regular intake of medication
- •food allergies / intolerances
- •vegans and vegetarians
- •regular high physical activity (exercise >1 hour/d)
- •current weight loss diet / weight loss of >5 kg in the last 3 months
- •pregnant / lactating women
- •persons incapable of giving informed legal consent
- •restraint eaters (according to the German version of the 'Three-Factor-Eating-Questionnaire', Stunkard und Messick (1985))
结局指标
主要结局
ad libitum energy intake
时间窗: 24 hours
ad libitum energy intake (kcal/day) of the foods consumed (breakfast, lunch, dinner, snacks)
energy expenditure
时间窗: 24 hours
measured with indirect calorimetry in a metabolic chamber (kcal/day)
次要结局
- macronutrient oxidation(24 hours)
- gastric emptying(5 hours after breakfast on first day of each intervention; intervals 15 min)
- appetite regulating hormone - GLP-1(5 hours after breakfast on second day of each intervention; intervals 30 min)
- appetite regulating hormone - PYY(5 hours after breakfast on second day of each intervention; intervals 30 min)
- appetite control - subjective feelings of hunger(5 hours after breakfast on first day of each intervention; intervals 30 min)
- glycemia - glucose AUC(24 hours)
- eating rate(3 x 30 per 24 hours (during main meals))
- oral processing behaviour (chewing)(3 x 30 per 24 hours (during main meals))
- appetite regulating hormone - ghrelin(5 hours after breakfast on second day of each intervention; intervals 30 min)
研究者
Prof. Dr. Dr. Anja Bosy-Westphal
Prof. Dr. Dr. Anja Bosy-Westphal
University of Kiel