Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The wireless motility capsule technology, SmartPill™, can be used to assess gastric emptying
      and gastrointestinal (GI) transit time. The SmartPill is usually ingested together with a
      SmartBar™ which is a snack bar with a nutrient composition that differs substantially from a
      normal western diet. The primary aim of the present study is to compare effects of a
      SmartBar™ and a standard mixed meal on gastric emptying and GI motility.
    

Detailed description: 
      Background: The wireless motility capsule technology, SmartPill™, can be used to assess GI
      transit time including gastric emptying and small and large bowel transit time based on
      measurements of pH, pressure and temperature. The SmartPill™ allows for GI motility
      measurements under free-living conditions without radiation. The SmartPill is usually
      ingested together with a SmartBar™ which is a snack bar with a nutrient composition that
      differs substantially from a normal western diet. GI motility in response to meals plays an
      important role in regulation of e.g. appetite and glucose metabolism. Changes in appetite and
      metabolism in response to interventions are often assessed using a meal test and GI motility
      is assessed at the research facilities. The use of SmartPill™ in combination with a meal test
      would allow for assessment of GI motility under subsequent free-living conditions and improve
      our understanding of the effects of interventions on the integrative relationship between
      food intake, GI motility and metabolism. Most of our daily decisions and actions affecting
      energy intake are driven by the non-conscious processes; however, appetite is often assessed
      from participants' self-report which is associated with limitations such as desire to report
      socially desirable answers. Little is known about the complex interrelationship between
      biological markers of appetite e.g. GI hormones and subjective and objective measures of food
      related behavior under fasting and fed conditions.

      The PRESET study has the following objectives:

        1. To compare effects of a SmartBar™ and a standard mixed breakfast meal on gastric
           emptying and GI transit time measured using the SmartPill™ in normal-weight individuals.

        2. To compare effects of a SmartBar™ and a standard mixed breakfast meal on concentrations
           of metabolites and pancreatic and GI hormones, and subjective and objective measures of
           appetite, food reward and food related behavior assessed from biometric responses
           (facial expression, galvanic skin response and eye tracking) to visual food stimuli
           varying in fat content and taste during the computerized Leeds Food Preference
           Questionnaire (LFPQ) in normal-weight individuals.

        3. To assess potential associations between gastric emptying and GI motility, biological
           markers of appetite and subjective appetite and objective measures of food related
           behavior from biometric responses to visual food stimuli during the LFPQ in the fasting
           state and in response to meals in normal-weight individuals.

      Testing includes assessments in the fasting state and in response to consumption of the
      SmartBar™ and a standard mixed meal (4-hour meal tests and subsequent 6-days free-living
      assessment period) on two separate test days.
    

Intervention name(s): Standard mixed breakfast meal; SmartBar™
Intervention type(s): Other; Other
Intervention description(s): The standard mixed breakfast meal consists of:
150 g yoghurt, 20 g muesli; 50 g wheat bun; 22 g rye bread; 25 g cheese; 25 g marmalade; 8 g butter; Total energy content: 500 kcal Macronutrient composition: 34 E% fat, 17 E% protein, 49 E% carbohydrate; SmarBar™ (Medtronic, North Haven, MA, USA). Weight: 72 g; Total energy content: 260 kcal Macronutrient composition: 7 E% fat, 19 E% protein, 74 E% carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a randomized cross-over study including 15 healthy normal-weight individuals. On two separate test days participants ingest the SmartPill™ in combination with a SmartBar™ (standard procedure, reference) or a standard mixed breakfast meal.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric emptying; Gastrointestinal transit; Food reward; Food preferences