The Omnibus Satiety Metric: Predicting Satiety in Humans Through Brain, Blood, and Subjective Data (NCT03900130) | Clinical Trial Compass
CompletedNot Applicable
The Omnibus Satiety Metric: Predicting Satiety in Humans Through Brain, Blood, and Subjective Data
Denmark24 participantsStarted 2017-10-18
Plain-language summary
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.
Who can participate
Age range
20 Years – 40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.