Clinical trial NCT03894670: Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
Official title: Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Keywords: Gastric emptying
Gastrointestinal transit
Food reward
Food preferences
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: IMotions A/S
name: University of Leeds
name: Aalborg University Hospital
First posted: 2019-03-28
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gastric emptying time (minutes)
timeFrame: Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)
Secondary outcomes:
measure: Small bowel transit time (minutes)
timeFrame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
measure: Large bowel transit time (minutes)
timeFrame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
measure: Total gastrointestinal transit time (minutes)
timeFrame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
measure: Motility index (arbitrary unit)
timeFrame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
measure: Metabolites
timeFrame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Hormones
timeFrame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Attention measured using eye tracking
timeFrame: 0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Arousal measured using galvanic skin response
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Emotions measured using facial expression analysis
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Food choice
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Implicit wanting
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Explicit liking
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Explicit wanting
timeFrame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Subjective appetite
timeFrame: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
measure: Self-reported gastrointestinal symptoms (part 1)
timeFrame: Answered during test days (0-240 minutes)
measure: Self-reported gastrointestinal symptoms (part 2)
timeFrame: Answered during test days (0-240 minutes)
measure: Self-reported gastrointestinal symptoms (part 3)
timeFrame: Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Self-reported autonomic symptoms
timeFrame: Answered during test days (0-240 minutes)
measure: Body weight (kg)
timeFrame: At 0 minutes (fasting) at both visits
measure: Body mass index (kg/m^2)
timeFrame: At 0 minutes (fasting) at both visits
measure: Fat mass (kg)
timeFrame: At 0 minutes (fasting) at both visits
measure: Fat percentage (%)
timeFrame: At 0 minutes (fasting) at both visits
measure: Fat free mass (kg)
timeFrame: At 0 minutes (fasting) at both visits
measure: Waist circumference (cm)
timeFrame: At 0 minutes (fasting) at both visits
measure: Hip circumference (cm)
timeFrame: At 0 minutes (fasting) at both visits
measure: Mean amplitude of glycaemic excursions (MAGE)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Continuous overall net glycaemic action (CONGA)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: 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)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Mean glucose concentrations
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Standard deviation of glucose concentrations
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Variation coefficients of glucose concentrations
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Resting energy expenditure (kcal/day)
timeFrame: At 0 minutes (fasting) at both visits
measure: Substrate oxidation (respiratory exchange ratio)
timeFrame: At 0 minutes (fasting) at both visits
measure: Systolic blood pressure (mmHg)
timeFrame: At 0 minutes (fasting) at both visits
measure: Diastolic blood pressure (mmHg)
timeFrame: At 0 minutes (fasting) at both visits
measure: Heart rate (bpm)
timeFrame: At 0 minutes (fasting) at both visits
measure: Heart rate response to standing up from the supine position
timeFrame: At 0 minutes (fasting) at both visits
measure: Heart rate response to inhalation and exhalation
timeFrame: At 0 minutes (fasting) at both visits
measure: Heart rate response to forced exhalation during rest (valsalva maneuver)
timeFrame: At 0 minutes (fasting) at both visits
measure: Microbiome content and diversity
timeFrame: One sample during 6 days after both visits
measure: Physical activity (time spent at different intensities)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Physical activity (counts/min)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Physical activity energy expenditure (kcal/day)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Physical activity (MET hours)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Timing of physical activity (hh:mm)
timeFrame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Energy intake (kcal/day)
timeFrame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Macronutrient intake (energy percentage)
timeFrame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Timing of dietary intake (hh:mm)
timeFrame: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Sleep timing (hh:mm)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Sleep duration (minutes)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Sleep variability (minutes)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Sleep onset latency (minutes)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Sleep efficiency (%)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: Wakefulness (minutes)
timeFrame: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
measure: HbA1c (mmol/mol and %)
timeFrame: At 0 minutes at both visits
measure: Insulin sensitivity (indices)
timeFrame: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively
measure: Insulin resistance (indices)
timeFrame: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Kristine Færch, PhD
role: PRINCIPAL_INVESTIGATOR
References: