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

Healthy Participants Clinical Trial

— PRESET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03894670
• Other study ID #: H-18026293
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: May 24, 2019

Study information

• Verified date: June 2019
• Source: Steno Diabetes Center Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Other:
• Standard mixed breakfast meal
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™
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.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Gentofte

Sponsors (5)

Lead Sponsor	Collaborator
Kristine Færch	Aalborg University Hospital, iMotions A/S, University of Copenhagen, University of Leeds

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying time (minutes)	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.	Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)
Secondary	Small bowel transit time (minutes)	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.	Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Secondary	Large bowel transit time (minutes)	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.	Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Secondary	Total gastrointestinal transit time (minutes)	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.	Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Secondary	Motility index (arbitrary unit)	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.	Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Secondary	Metabolites	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.	0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Hormones	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)).	0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Attention measured using eye tracking	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	0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Arousal measured using galvanic skin response	Changes in conductivity of skin (galvanic skin response) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Emotions measured using facial expression analysis	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	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Food choice	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.	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Implicit wanting	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.	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Explicit liking	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).	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Explicit wanting	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).	0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Subjective appetite	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".	0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Secondary	Self-reported gastrointestinal symptoms (part 1)	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.	Answered during test days (0-240 minutes)
Secondary	Self-reported gastrointestinal symptoms (part 2)	Assessed from the Gastrointestinal Symptom Score (PAGI-SYM). Rated on 6-point likert scales. Range: 1 = absence of symptoms to 6 = very severe symptoms.	Answered during test days (0-240 minutes)
Secondary	Self-reported gastrointestinal symptoms (part 3)	Number of symptoms. Assessed from logs.	Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Self-reported autonomic symptoms	Assessed from the questionnaire COMPASS31	Answered during test days (0-240 minutes)
Secondary	Body weight (kg)	Body weight is measured on a digital scale	At 0 minutes (fasting) at both visits
Secondary	Body mass index (kg/m^2)	Calculated from body weight (kg) and height (m)	At 0 minutes (fasting) at both visits
Secondary	Fat mass (kg)	Measured by Dual-energy X-ray Absorptiometry	At 0 minutes (fasting) at both visits
Secondary	Fat percentage (%)	Measured by Dual-energy X-ray Absorptiometry	At 0 minutes (fasting) at both visits
Secondary	Fat free mass (kg)	Measured by Dual-energy X-ray Absorptiometry	At 0 minutes (fasting) at both visits
Secondary	Waist circumference (cm)	Measured using tape measure	At 0 minutes (fasting) at both visits
Secondary	Hip circumference (cm)	Measured using tape measure	At 0 minutes (fasting) at both visits
Secondary	Mean amplitude of glycaemic excursions (MAGE)	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Continuous overall net glycaemic action (CONGA)	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	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)	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Mean glucose concentrations	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Standard deviation of glucose concentrations	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Variation coefficients of glucose concentrations	Measured using continous glucose monitoring	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Resting energy expenditure (kcal/day)	Measured by indirect calorimetry under resting and fasting conditions	At 0 minutes (fasting) at both visits
Secondary	Substrate oxidation (respiratory exchange ratio)	Measured by indirect calorimetry under resting and fasting conditions	At 0 minutes (fasting) at both visits
Secondary	Systolic blood pressure (mmHg)	Measured under resting and fasting conditions	At 0 minutes (fasting) at both visits
Secondary	Diastolic blood pressure (mmHg)	Measured under resting and fasting conditions	At 0 minutes (fasting) at both visits
Secondary	Heart rate (bpm)	Measured under resting and fasting conditions during measurements of blood pressure and in the supine position by a handheld ECG measuring device (Vagus™).	At 0 minutes (fasting) at both visits
Secondary	Heart rate response to standing up from the supine position	Measured by a handheld ECG measuring device (Vagus™).	At 0 minutes (fasting) at both visits
Secondary	Heart rate response to inhalation and exhalation	Measured by a handheld ECG measuring device (Vagus™).	At 0 minutes (fasting) at both visits
Secondary	Heart rate response to forced exhalation during rest (valsalva maneuver)	Measured by a handheld ECG measuring device (Vagus™).	At 0 minutes (fasting) at both visits
Secondary	Microbiome content and diversity	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.	One sample during 6 days after both visits
Secondary	Physical activity (time spent at different intensities)	Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Physical activity (counts/min)	Assessed from 24 h/day accelerometry	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Physical activity energy expenditure (kcal/day)	Assessed from 24 h/day accelerometry	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Physical activity (MET hours)	Assessed from 24 h/day accelerometry	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Timing of physical activity (hh:mm)	Assessed from activity logs and 24 h/day accelerometry	Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Energy intake (kcal/day)	Assessed from diet records	Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Macronutrient intake (energy percentage)	Assessed from diet records	Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Timing of dietary intake (hh:mm)	Assessed from diet records	Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Sleep timing (hh:mm)	Including bedtime, sleep onset, wake-up, time out of bed, sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Sleep duration (minutes)	Assessed from sleep logs and 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Sleep variability (minutes)	Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Sleep onset latency (minutes)	Assessed from sleep logs and 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Sleep efficiency (%)	Assessed from 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	Wakefulness (minutes)	Assessed from 24 h/day accelerometry	Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Secondary	HbA1c (mmol/mol and %)	Hemoglobin A1c	At 0 minutes at both visits
Secondary	Insulin sensitivity (indices)	Including but not limited to the Matsuda index	At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively
Secondary	Insulin resistance (indices)	Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively