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Completed

NCT Number: NCT03894670

Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study

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.

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Key information

Conditions

Healthy Participants Behavior Feeding Behavior Food Preferences

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2810, Denmark

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index: 18.5 to 24.9 kg/m2

Exclusion criteria

  • Unable to understand the informed consent and the study procedures;
  • Self-reported history of an eating disorder in the past three years
  • Self-reported weight change (>5 kg) within three months prior to inclusion
  • HbA1c: ≥5.7 % (≥39 mmol/mol)
  • Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, GI or psychiatric disease; diabetes or other endocrine disease; immunosuppression
  • Current treatment with medication or medical devices which affect GI motility and transit time (prokinetics, antidiarrheals, laxatives)
  • Current treatment with medication which affect glucose metabolism or appetite
  • Current treatment with beta blockers or peroral steroids
  • Current treatment with non-steroidal anti-inflammatory drugs, tricyclic antidepressants, selective serotonin re-uptake inhibitors or opioids
  • Bariatric surgery
  • GI symptoms or diseases such as regular (weekly) abdominal pain, dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, celiac disease, Crohn's disease, ulcerative colitis or proctitis
  • Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion
  • Pregnant or lactating women
  • Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices
  • Concomitant participation in other research studies

Treatment and study plan

Standard mixed breakfast meal

Other

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

SmartBar™

Other

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.

Primary outcomes

  1. Gastric emptying time (minutes)

    Time frame: Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)

    Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual gastric emptying time.

Secondary outcomes

  1. Small bowel transit time (minutes)

    Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

    Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual transit time.

  2. Large bowel transit time (minutes)

    Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

    Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual transit time.

  3. Total gastrointestinal transit time (minutes)

    Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

    Measured by the SmartPill™ technique. The SmartPill™ is ingested at both visits in combination with the standard breakfast meal and SmartBar™, respectively. The time frame depends on the individual transit time.

  4. Motility index (arbitrary unit)

    Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)

    Calculated based on amplitudes and number of contractions measured using the SmartPill™ technique. The greater the motility index the greater the gastrointestinal motility (i.e. more frequent and stronger contractions). A higher motility index has been observed among healthy participants compared to patients with diabetic gastroparesis indicating that a higher index is favorable.

  5. Metabolites

    Time frame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Concentrations of metabolites (including but not limited to: glucose, lipids, cholesterol, free-fatty acids, and amino acids. Measured at both visits in the fasting state and for 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively.

  6. Hormones

    Time frame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Concentrations of hormones related to regulation of appetite, glucose and lipid metabolism (including but not limited to: insulin, glucagon, ghrelin, glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and peptide YY (PYY), leptin, fibroblast growth factor 19 (FGF-19), fibroblast growth factor 21 (FGF-21), growth differentiation factor 15 (GDF-15)).

  7. Attention measured using eye tracking

    Time frame: 0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Eye tracking metrics including gaze duration bias, gaze direction bias, fixations, saccades, pupil size/dilation, distance to screen, ocular vergence and blinks to measure attention in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  8. Arousal measured using galvanic skin response

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Changes in conductivity of skin (galvanic skin response) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  9. Emotions measured using facial expression analysis

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Facial expression analyses using computer-vision algorithms (AFFDEX) to measure emotions in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire

  10. Food choice

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.

  11. Implicit wanting

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time.

  12. Explicit liking

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this food right now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

  13. Explicit wanting

    Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the computerized Leeds Food Preference Questionnaire. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).

  14. Subjective appetite

    Time frame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)

    Rated using visual analogue scales and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, and sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before".

  15. Self-reported gastrointestinal symptoms (part 1)

    Time frame: Answered during test days (0-240 minutes)

    Assessed from the questionnaire the Gastrointestinal Symptom Rating Scale (GSRS). Rated on 7-point likert scales. Range: 1 = absence of symptoms to 7 = very severe symptoms.

  16. Self-reported gastrointestinal symptoms (part 2)

    Time frame: Answered during test days (0-240 minutes)

    Assessed from the Gastrointestinal Symptom Score (PAGI-SYM). Rated on 6-point likert scales. Range: 1 = absence of symptoms to 6 = very severe symptoms.

  17. Self-reported gastrointestinal symptoms (part 3)

    Time frame: Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Number of symptoms. Assessed from logs.

  18. Self-reported autonomic symptoms

    Time frame: Answered during test days (0-240 minutes)

    Assessed from the questionnaire COMPASS31

  19. Body weight (kg)

    Time frame: At 0 minutes (fasting) at both visits

    Body weight is measured on a digital scale

  20. Body mass index (kg/m^2)

    Time frame: At 0 minutes (fasting) at both visits

    Calculated from body weight (kg) and height (m)

  21. Fat mass (kg)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by Dual-energy X-ray Absorptiometry

  22. Fat percentage (%)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by Dual-energy X-ray Absorptiometry

  23. Fat free mass (kg)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by Dual-energy X-ray Absorptiometry

  24. Waist circumference (cm)

    Time frame: At 0 minutes (fasting) at both visits

    Measured using tape measure

  25. Hip circumference (cm)

    Time frame: At 0 minutes (fasting) at both visits

    Measured using tape measure

  26. Mean amplitude of glycaemic excursions (MAGE)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  27. Continuous overall net glycaemic action (CONGA)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  28. Daily time spent above different glucose concentrations (e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  29. Mean glucose concentrations

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  30. Standard deviation of glucose concentrations

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  31. Variation coefficients of glucose concentrations

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Measured using continous glucose monitoring

  32. Resting energy expenditure (kcal/day)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by indirect calorimetry under resting and fasting conditions

  33. Substrate oxidation (respiratory exchange ratio)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by indirect calorimetry under resting and fasting conditions

  34. Systolic blood pressure (mmHg)

    Time frame: At 0 minutes (fasting) at both visits

    Measured under resting and fasting conditions

  35. Diastolic blood pressure (mmHg)

    Time frame: At 0 minutes (fasting) at both visits

    Measured under resting and fasting conditions

  36. Heart rate (bpm)

    Time frame: At 0 minutes (fasting) at both visits

    Measured under resting and fasting conditions during measurements of blood pressure and in the supine position by a handheld ECG measuring device (Vagus™).

  37. Heart rate response to standing up from the supine position

    Time frame: At 0 minutes (fasting) at both visits

    Measured by a handheld ECG measuring device (Vagus™).

  38. Heart rate response to inhalation and exhalation

    Time frame: At 0 minutes (fasting) at both visits

    Measured by a handheld ECG measuring device (Vagus™).

  39. Heart rate response to forced exhalation during rest (valsalva maneuver)

    Time frame: At 0 minutes (fasting) at both visits

    Measured by a handheld ECG measuring device (Vagus™).

  40. Microbiome content and diversity

    Time frame: One sample during 6 days after both visits

    Determined from stool samples. Bacterial DNA and RNA will be purified from the stool samples and changes in the microbiome composition and function will be estimated based on sequencing of the microbiomes' DNA and RNA. Includes but is not limited to the Firmicutes/Bacteroidetes ratio.

  41. Physical activity (time spent at different intensities)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry

  42. Physical activity (counts/min)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from 24 h/day accelerometry

  43. Physical activity energy expenditure (kcal/day)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from 24 h/day accelerometry

  44. Physical activity (MET hours)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from 24 h/day accelerometry

  45. Timing of physical activity (hh:mm)

    Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from activity logs and 24 h/day accelerometry

  46. Energy intake (kcal/day)

    Time frame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from diet records

  47. Macronutrient intake (energy percentage)

    Time frame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from diet records

  48. Timing of dietary intake (hh:mm)

    Time frame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from diet records

  49. Sleep timing (hh:mm)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Including bedtime, sleep onset, wake-up, time out of bed, sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry

  50. Sleep duration (minutes)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from sleep logs and 24 h/day accelerometry

  51. Sleep variability (minutes)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry

  52. Sleep onset latency (minutes)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from sleep logs and 24 h/day accelerometry

  53. Sleep efficiency (%)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from 24 h/day accelerometry

  54. Wakefulness (minutes)

    Time frame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)

    Assessed from 24 h/day accelerometry

  55. HbA1c (mmol/mol and %)

    Time frame: At 0 minutes at both visits

    Hemoglobin A1c

  56. Insulin sensitivity (indices)

    Time frame: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively

    Including but not limited to the Matsuda index

  57. Insulin resistance (indices)

    Time frame: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively

    Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Sponsors and collaborators

Lead sponsor

Kristine Færch

Other

Collaborators

  • Aalborg University Hospital
  • IMotions A/S
  • University of Copenhagen
  • University of Leeds

Registry information

Acronym: PRESET

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2019
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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