The Omnibus Satiety Metric (OmniSaM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Ad libitum energy consumption
研究概览
简要总结
Designing food and drink that maximizes satiety has long been an ambition of industry and public health.
For obvious reasons, foods that fill faster and for longer are desirable to consumers for controlling their weight, and to public health programs that are designed to prevent obesity.
Current methods for measuring satiety have weak predictive value, commonly fail to replicate, and are yet to be validated with respect to energy consumption in everyday life.
The investigators propose to overcome this deficiency by developing the Omnibus Satiety Metric (OmniSaM).
OmniSaM is proposed as a multi-modal metric that targets the full spectrum of processes underlying the satiety cascade, composing brain, blood, mind and behavior of consumers.
As a proof-of-concept, subjects (normal BMI) will undergo a preload ad libitum paradigm, with a 2-parameter factorial design comparing milk based products differing in levels of caloric load and protein-to-carbohydrate ratio.
The investigators will acquire 1. high-resolution neuroimaging data, whilst 2. simultaneously recording appetitive hormones, 3. blood metabolite composition, 4. subjective sensory indices of appetite and 4. behavioral metrics of consumption.
详细描述
The overarching strategy is to give subjects preload foods of variable combinations of protein-to-carbohydrate ratios (two levels) and caloric load (two levels), testing the effect this has on ad libitum consumption, using neuroimaging, sensory and endocrine metrics as predictor variables.
The investigators will conduct a repeated measures cross-over study, meaning that all subjects will be exposed to all four combinations of protein-to-carbohydrate ratio and caloric loads.
A total of 25 subjects will complete the study. Subjets will consume a shake preload drink outside the Magnetic Resonance-scanner (MR-scanner) and after a wait time of 4 hours during which scanning, endocrine and sensory measures are obtained, the subjects will eat an ad libitum meal consisting of standardized prepared spaghetti bolognese.
Endocrine and sensory measures will continue until one hour after intake of the ad libitum meal. All subjects will undergo four test days of ~5 hours in the Danish Research Centre for Magnetic Resonance (DRCMR), Hvidovre Hospital, a maximum of one test day per week because of blood loss considerations.
On study days the participants will arrive at 11:30am having fasted since 22:00 the previous evening with a fixed consumption of 200 ml of water in the morning 2 hours before the test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The study is a repeated measures design. It is double blinded in the sense that the participant, brain imager and endocrinologist are masked from the preload condition. One technician is unblinded as to the preload type. The participant is not aware of the possible ways in which the preload can vary, or even that it could vary over testdays.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male
- •Aged 20-40 years old
- •Normal hematology, kidney and liver function
- •Normal weight (BMI 18.5-24.9)
- •Weight stable defined as +/- 5 kg within 3 months prior to test start
- •Liking milk
- •Liking spaghetti bolognaise
排除标准
- •Suffer or have suffered from any metabolic disorders
- •Suffer or have suffered from any psychiatric disorders
- •Suffer or have suffered from any neurological disorders
- •Restrained eating behavior or caloric restriction
- •Claustrophobia
- •Implanted with pacemakers or other implanted electronic devices
- •Concentration of hemoglobin <8mMol/L,
- •Alanintransaminase >70 U/L
- •Alkaline phosphatase >105 U/L
- •Bilirubin >25 micromol/L
- •Coagulationfactors (INR) >1.2
- •eGFR <60 ml/min
- •hba1c >48 mmol/mol
研究组 & 干预措施
Full group
There is only one arm in this study. The group of 25 subjects all undergo a repeated measures 2 x 2 factorial design, fully crossed such that all subjects are tested under all four combinations of factors.
The intervention "Preload" amounts to two factors, caloric load and protein to carbohydrate ratio of the preload, both of which can take on two levels high or low.
干预措施: Preload (Dietary Supplement)
结局指标
主要结局
Ad libitum energy consumption
时间窗: 3 hours after the preload
The energy content in calories of the spaghetti consumed under ad libitum conditions
次要结局
未报告次要终点
研究者
Derek Victor Byrne
Professor
University of Aarhus