The Omnibus Satiety Metric: Predicting Satiety in Humans Through Brain, Blood, and Subjective Data

NCT03900130 | Completed

• 1 other identifier: H-17007959
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Satiation; Appetite; Behavior; Hunger

Keywords

hunger, satiety, satiety cascade, satiating capacity

Outcome Measures

Primary Outcomes (1)

• Ad libitum energy consumption

  The energy content in calories of the spaghetti consumed under ad libitum conditions

  3 hours after the preload

Study Arms (1)

Full group

EXPERIMENTAL

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.

Dietary Supplement: Preload

Interventions

Preload DIETARY_SUPPLEMENT

In the 2 x 2 factorial design we vary two factors: 1. caloric load of the preload such that it is either high calorie or low. 2. protein to carbohydrate ratio of the preload such that it is either high or low

Full group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Derek Victor Byrne: lead
• University of Copenhagen: collaborator
• Danish Research Centre for Magnetic Resonance: collaborator

Study Sites (1)

Oliver Hulme

København S, Region Sjælland, 2300, Denmark

Location

MeSH Terms

Conditions

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Repeated measures, fully crossed, factorial design with caloric load and protein to carbohydrate ratio of preload as 2-level factors.

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 2, 2019
• Study Start: October 18, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

DK (1)