跳至主要内容
临床试验/NCT05337007
NCT05337007已完成不适用

Impact of Protein Content of Ultraprocessed Foods on the Regulation of Energy Balance (ad Libitum Energy Intake and Energy Expenditure)

University of Kiel1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
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.

  1. 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
  2. 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))

研究组 & 干预措施

dietary intervention, high protein diet

Experimental

commercially available high protein ultraprocessed food items (30% protein content), cross-over design, all subjects receive all interventions

干预措施: high protein diet (Other)

dietary intervention, moderate protein diet

Active Comparator

commercially available moderate protein ultraprocessed food items (13% protein content), cross-over design, all subjects receive all interventions

干预措施: moderate protein diet (Other)

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

  • 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))
  • macronutrient oxidation(24 hours)
  • gastric emptying(5 hours after breakfast on first day of each intervention; intervals 15 min)
  • appetite regulating hormone - ghrelin(5 hours after breakfast on second day of each intervention; intervals 30 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Dr. Anja Bosy-Westphal

Prof. Dr. Dr. Anja Bosy-Westphal

University of Kiel

研究点 (1)

Loading locations...

相似试验