Healthy ParticipantsPRESETNCT03894670
Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
A study testing Standard mixed breakfast meal and SmartBar™ in people with Healthy Participants, run by Kristine Færch at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Standard mixed breakfast meal and SmartBar™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Oct 2018to 24 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index: 18.5 to 24.9 kg/m2
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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:
- 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.
- Conditions
- Healthy Participants
- Being tested
- Standard mixed breakfast meal, SmartBar™
- Keywords
- Gastric emptying, Gastrointestinal transit, Food reward, Food preferences
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard mixed breakfast mealOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SmartBar™ | Active comparator | The wireless capsule technology, 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. Receives: Other: SmartBar™ |
| Standard mixed breakfast meal | Experimental | The SmartPill™ is ingested together with a standard mixed breakfast meal and the outcomes of interest will be compared with the SmartBar™ condition (reference). Receives: Other: Standard mixed breakfast meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)
Secondary outcomes (57)
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.
Measured: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
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.
Measured: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
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.
Measured: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
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.
Measured: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
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.
Measured: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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)).
Measured: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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
Measured: 0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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.
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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.
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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).
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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).
Measured: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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".
Measured: 0 minutes (fasting) and 15, 30, 45, 60, 90, 120, 180, 240 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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.
Measured: Answered during test days (0-240 minutes)
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.
Measured: Answered during test days (0-240 minutes)
Self-reported gastrointestinal symptoms (part 3)
Number of symptoms. Assessed from logs.
Measured: Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Self-reported autonomic symptoms
Assessed from the questionnaire COMPASS31
Measured: Answered during test days (0-240 minutes)
Body weight (kg)
Body weight is measured on a digital scale
Measured: At 0 minutes (fasting) at both visits
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m)
Measured: At 0 minutes (fasting) at both visits
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: At 0 minutes (fasting) at both visits
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry
Measured: At 0 minutes (fasting) at both visits
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: At 0 minutes (fasting) at both visits
Waist circumference (cm)
Measured using tape measure
Measured: At 0 minutes (fasting) at both visits
Hip circumference (cm)
Measured using tape measure
Measured: At 0 minutes (fasting) at both visits
Mean amplitude of glycaemic excursions (MAGE)
Measured using continous glucose monitoring
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Continuous overall net glycaemic action (CONGA)
Measured using continous glucose monitoring
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
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: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Mean glucose concentrations
Measured using continous glucose monitoring
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Standard deviation of glucose concentrations
Measured using continous glucose monitoring
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Variation coefficients of glucose concentrations
Measured using continous glucose monitoring
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Resting energy expenditure (kcal/day)
Measured by indirect calorimetry under resting and fasting conditions
Measured: At 0 minutes (fasting) at both visits
Substrate oxidation (respiratory exchange ratio)
Measured by indirect calorimetry under resting and fasting conditions
Measured: At 0 minutes (fasting) at both visits
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: At 0 minutes (fasting) at both visits
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: At 0 minutes (fasting) at both visits
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™).
Measured: At 0 minutes (fasting) at both visits
Heart rate response to standing up from the supine position
Measured by a handheld ECG measuring device (Vagus™).
Measured: At 0 minutes (fasting) at both visits
Heart rate response to inhalation and exhalation
Measured by a handheld ECG measuring device (Vagus™).
Measured: At 0 minutes (fasting) at both visits
Heart rate response to forced exhalation during rest (valsalva maneuver)
Measured by a handheld ECG measuring device (Vagus™).
Measured: At 0 minutes (fasting) at both visits
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.
Measured: One sample during 6 days after both visits
Physical activity (time spent at different intensities)
Sedentary time, light, moderate and vigorous intensity physical activity. Assessed from 24 h/day accelerometry
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Physical activity (counts/min)
Assessed from 24 h/day accelerometry
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Physical activity energy expenditure (kcal/day)
Assessed from 24 h/day accelerometry
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Physical activity (MET hours)
Assessed from 24 h/day accelerometry
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Timing of physical activity (hh:mm)
Assessed from activity logs and 24 h/day accelerometry
Measured: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Energy intake (kcal/day)
Assessed from diet records
Measured: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Macronutrient intake (energy percentage)
Assessed from diet records
Measured: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Timing of dietary intake (hh:mm)
Assessed from diet records
Measured: Assessed for 3 days after both visits (standard breakfast meal and the SmartBar™ conditions)
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
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Sleep duration (minutes)
Assessed from sleep logs and 24 h/day accelerometry
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Sleep variability (minutes)
Variability in bedtime, wake-up, sleep duration and sleep midpoint. Assessed from sleep logs and 24 h/day accelerometry
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Sleep onset latency (minutes)
Assessed from sleep logs and 24 h/day accelerometry
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Sleep efficiency (%)
Assessed from 24 h/day accelerometry
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Wakefulness (minutes)
Assessed from 24 h/day accelerometry
Measured: Assessed for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
HbA1c (mmol/mol and %)
Hemoglobin A1c
Measured: At 0 minutes at both visits
Insulin sensitivity (indices)
Including but not limited to the Matsuda index
Measured: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively
Insulin resistance (indices)
Including but not limited to Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: At 0 minutes (fasting) and 4 hours after consumption of the standard breakfast meal and the SmartBar™, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start16 Oct 2018
- Primary completion24 May 2019
- Study completion24 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristine Færch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, IMotions A/S, University of Leeds, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Kristine Færch, Steno Diabetes Center Copenhagen
- Investigators
- Kristine Færch, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894670
- Sponsor's protocol ID
- H-18026293
- Acronym
- PRESET
- Status last verified
- Jun 2019
- First submitted
- 12 Mar 2019
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.
PubMed 37315794
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Methods for Measuring Gastrointestinal Transit and Food Reward in Healthy Individuals - The PRESET Study
- ClinicalTrials.gov ID
- NCT03894670
- Acronym / sponsor ID
- PRESET / H-18026293
- Conditions
- Healthy Participants
- Keywords
- Gastric emptying, Gastrointestinal transit, Food reward, Food preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kristine FærchUniversity, hospital or other
- Collaborators
- University of Copenhagen, IMotions A/S, University of Leeds, Aalborg University Hospital
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 24 May 2019 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SmartBar™ | Active comparator | Other: SmartBar™The wireless capsule technology, 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. |
| Standard mixed breakfast meal | Experimental | Other: Standard mixed breakfast mealThe SmartPill™ is ingested together with a standard mixed breakfast meal and the outcomes of interest will be compared with the SmartBar™ condition (reference). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body mass index: 18.5 to 24.9 kg/m2
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard mixed breakfast mealThe 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 | Other | Standard mixed breakfast meal |
| 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. | Other | SmartBar™ |
Primary outcome
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.
57 secondary outcomes
Small bowel transit time (minutes)
Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Large bowel transit time (minutes)
Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Total gastrointestinal transit time (minutes)
Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
Motility index (arbitrary unit)
Time frame: Within 5 days after both visits (standard breakfast meal and SmartBar™, respectively)
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)
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)
Attention measured using eye tracking
Time frame: 0 minutes (fasting) at 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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)
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)
Food choice
Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Implicit wanting
Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Explicit liking
Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
Explicit wanting
Time frame: 0 minutes (fasting) and after 60 minutes (after consumption of the standard breakfast meal and SmartBar™, respectively)
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)
Self-reported gastrointestinal symptoms (part 1)
Time frame: Answered during test days (0-240 minutes)
Self-reported gastrointestinal symptoms (part 2)
Time frame: Answered during test days (0-240 minutes)
Self-reported gastrointestinal symptoms (part 3)
Time frame: Registered 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Self-reported autonomic symptoms
Time frame: Answered during test days (0-240 minutes)
Body weight (kg)
Time frame: At 0 minutes (fasting) at both visits
Body mass index (kg/m^2)
Time frame: At 0 minutes (fasting) at both visits
Fat mass (kg)
Time frame: At 0 minutes (fasting) at both visits
Fat percentage (%)
Time frame: At 0 minutes (fasting) at both visits
Fat free mass (kg)
Time frame: At 0 minutes (fasting) at both visits
Waist circumference (cm)
Time frame: At 0 minutes (fasting) at both visits
Hip circumference (cm)
Time frame: At 0 minutes (fasting) at both visits
Mean amplitude of glycaemic excursions (MAGE)
Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Continuous overall net glycaemic action (CONGA)
Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
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)
Mean glucose concentrations
Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Standard deviation of glucose concentrations
Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Variation coefficients of glucose concentrations
Time frame: Measured for 6 days after both visits (standard breakfast meal and the SmartBar™ conditions)
Resting energy expenditure (kcal/day)
Time frame: At 0 minutes (fasting) at both visits
Substrate oxidation (respiratory exchange ratio)
Time frame: At 0 minutes (fasting) at both visits
Systolic blood pressure (mmHg)
Time frame: At 0 minutes (fasting) at both visits
Diastolic blood pressure (mmHg)
Time frame: At 0 minutes (fasting) at both visits
Heart rate (bpm)
Time frame: At 0 minutes (fasting) at both visits
Heart rate response to standing up from the supine position
Time frame: At 0 minutes (fasting) at both visits
Heart rate response to inhalation and exhalation
Time frame: At 0 minutes (fasting) at both visits
Heart rate response to forced exhalation during rest (valsalva maneuver)
Time frame: At 0 minutes (fasting) at both visits
Microbiome content and diversity
Time frame: One sample during 6 days after both visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
- Derived from this study: PubMed 37315794Jensen MM, Pedersen HE, Clemmensen KKB, Ekblond TS, Ried-Larsen M, Faerch K, Brock C, Quist JS. Associations Between Physical Activity and Gastrointestinal Transit Times in People with Normal Weight, Overweight, and Obesity. J Nutr. 2024 Jan;154(1):41-48. doi: 10.1016/j.tjnut.2023.06.005. Epub 2023 Jun 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Færch, PhD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard mixed breakfast meal and SmartBar™ in people with Healthy Participants, run by Kristine Færch at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying time (minutes) (time frame: Within 24 hours from ingestion of the SmartPill™ at both visits (standard breakfast meal and SmartBar™, respectively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03894670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.