Healthy ParticipantsPRESETNCT03986619
Evaluation of Methods for Measuring Food Reward and Food-related Behavior in Healthy Individuals
An observational study of Healthy Participants, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Most of the decisions and actions affecting energy balance are driven by implicit and explicit motivational processes. In modern obesogenic environment where highly palatable and energy-dense foods are easily available, it is of great interest to increase the understanding of both implicit and explicit processes of… 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
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Oct 2018to 29 Aug 2019
- Phase
- Observational
- 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
Study population: Normal-weight individuals
Who may be able to join
- Age: from ≥30 to ≤70 years of age
- BMI: from 18.5 to 24.9 kg/m2
Who cannot join
- Unable to understand the informed consent and the study procedures;
- Allergic to the food items included in the taste test
- Self-reported history of an eating disorder in the past three years
- Self-reported weight change (>5 kg) within three months prior to inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Methods for Measuring Food Reward and Food-related Behavior in Healthy Individuals - a Substudy of the PRESET Study
Most of the decisions and actions affecting energy balance are driven by implicit and explicit motivational processes. In modern obesogenic environment where highly palatable and energy-dense foods are easily available, it is of great interest to increase the understanding of both implicit and explicit processes of food-related behavior.
The aim of the present study is to examine whether biometric signatures in response to visual food stimuli during the already validated Leeds Food Preference Questionnaire (LFPQ) correlate with liking, wanting, food choice, or subsequent ad libitum food intake of those foods as assessed by the LFPQ and an ad libitum buffet meal.
Read the detailed description
Human behaviour including food reward plays a pivotal role in appetite regulation and the type and amount of food eaten. Food reward is a driver of eating behaviour and is defined as the momentary value of a food to the individual at the time of ingestion. Food reward contains the components of liking and wanting that can exist both with (explicit) and without (implicit) conscious awareness. Most of the daily decisions and actions affecting energy balance are driven by the non-conscious mind. Non-conscious processes are characterised by being unintentional and without awareness of the effects of triggering stimuli, e.g. food items. Contrary, conscious processes are typically assessed through participants' self-reports but limited by accuracy and desire to provide socially desirable answers. In a world of plenty where foods are always easily available with an overtly representation of highly palatable and energy-dense foods it is of great interest to understand the role of the non-conscious mind as a driver of food choice and intake. Intake of highly palatable and energy-dense foods is related to excess energy intake, high body mass index and weight gain. A possible explanation for this is that these foods are overall more rewarding and as a result of this, palatable.
A few previous studies have applied the use of innovative biometric measures, i.e. eye tracking, galvanic skin response, and facial expression to examine behavioural aspects of food intake that are without conscious awareness. However, there is a lack of studies examining how biometric responses to different food groups varying in energy density and palatability correlate with outcomes related to components of food reward and food intake. Therefore, in the present explorative study the above-mentioned biometric measurements will be combined with an existing validated method, the Leeds Food Preference Questionnaire (LFPQ), developed to examine both non-conscious and conscious components of food reward. The LFPQ assess four factors related to food reward within four combined food categories: food choice, implicit and explicit wanting, and explicit liking for high-fat sweet foods, low-fat sweet foods, high-fat savoury foods, and low-fat savoury foods. Biometric measurements of eye tracking can provide measures of attention, measurements of galvanic skin response can provide measures of arousal, and facial expressions analyses can provide information on emotional responses in response to selected stimuli, which in this study constitute pictures of food items. Furthermore, the study will include a taste task including an ad libitum intake of test foods in order to examine responses to actual food intake and to compare these responses to biometric responses to visual food stimuli.
- Conditions
- Healthy Participants
- Keywords
- Food preferences, Food reward
- Medical subject headings
- Food Preferences
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaze duration bias (ratio)
A measure of attention measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.
Gaze duration bias is calculated as the average gaze duration (ms) to a specific food image relative to the average gaze duration to all images.
A bias score ˃0.5 indicates maintained attention towards a food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates maintained attention towards the other food images.
Measured: 0 minutes (fasting)
Secondary outcomes (33)
Attention
Measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.
Includes the following parameters: Gaze: Time spent (ms and %) and revisits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score ˃0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.
Measured: 0 minutes (fasting)
Arousal
Measured as galvanic skin response (changes in conductivity of the skin) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.
Includes the following parameters: Presence of a peak (yes/no), peak count (n), peaks/min, peak (ms), peak amplitude (μS), peak onset (ms), peak offset (ms), duration (ms), tonic signal (μS).
The presence of a peak, the magnitude of the peak as well as the duration of the peak are measures of arousal (includes all the parameters listed above). The greater the response the higher the arousal.
Measured: 0 minutes (fasting)
Emotions
Emotions including anger, sadness, disgust, joy, surprise, fear, contempt as well as facial expression metrics (actions units) are determined by facial expression analysis using computer-vision algorithms (AFFDEX) in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire.
Results represent the probability the emotions and facial expression metrics were expressed (range: 0-100; 0=it was not expressed, 100=it was expressed, 50=50% likelihood that it was expressed).
Measured: 0 minutes (fasting)
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)
Reaction time (ms)
Reaction time during forced 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.
Measured: 0 minutes (fasting)
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 (a frequency-weighted algorithm).
In this frequency-weighted algorithm a positive score indicates a more rapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm is used so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixed min-max value)
Measured: 0 minutes (fasting)
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)
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)
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)
Body weight (kg)
Body weight is measured on a digital scale
Measured: 0 minutes (fasting)
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m)
Measured: 0 minutes (fasting)
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: 0 minutes (fasting)
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry
Measured: 0 minutes (fasting)
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry
Measured: 0 minutes (fasting)
Waist circumference (cm)
Measured using tape measure
Measured: 0 minutes (fasting)
Hip circumference (cm)
Measured using tape measure
Measured: 0 minutes (fasting)
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: 0 minutes (fasting)
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions
Measured: 0 minutes (fasting)
Heart rate (bpm)
Measured under resting and fasting conditions
Measured: 0 minutes (fasting)
HbA1c (mmol/mol and %)
Hemoglobin A1c
Measured: 0 minutes (fasting)
Sleep quality
Assessed using the Pittsburgh Sleep Quality Index. The questionnaire covers sleep quality and sleep disturbances over the preceding month and includes 19 individual items that generate seven scores weighted on a 0-3 scale. The sum of the component scores yields a total score of 0-21, and the higher the score, the poorer the sleep quality. The questionnaire also covers bedtime (hh:mm), sleep onset latency (minutes/night), wake-up (hh:mm); sleep duration (hours and minutes per night).
Measured: 0 minutes (fasting)
Sleepiness
Assessed using the Epworth Sleepiness Scale. The questionnaire describes eight different situations of everyday life, and participants are asked to rate how likely they would doze off or fall asleep in each situation on a 0-3 scale. The sum of the scores yields a total score of 0-24, with higher scores indicative of greater daytime sleepiness.
Measured: 0 minutes (fasting)
Self-reported health
Assessed using the Short Form Health Survey (SF-36). The questionnaire covers self-reported health status and the response format is a Likert-type scale e.g. question regarding overall health from 1=excellent to 5=poor and binary scales (yes/no) e.g. "difficulties performing daily tasks".
Measured: 0 minutes (fasting)
Physical activity
Assessed using the Recent Physical Activity Questionnaire. The questionnaire covers physical activity during work and in transport and leisure-time domains. The response format is a Likert-type scale e.g. 1=never and 5=always and participants are also asked about distance to work and typical mode of transportation. The time spent (minutes/day) on different modes of transportation or work-related or leisure-time physical activities and exercise as well as intensity (sedentary, light, moderate, vigorous) of the activities can be calculated.
Measured: Minimum 6 hours after test day
Chronotype
Assessed using the Munich Chronotype Questionnaire. The primary outcome is sleep midpoint (hh:mm) calculated based on participants' registration of habitual bedtime (hh:mm), sleep onset (hh:mm), sleep onset latency (minutes), wake-up (hh:mm), time from wake-up to out of bed (minutes). The questionnaire also covers use of sleep medicine and intake of alcohol and coffee/tea (units/day, units/ week, units/months), type of transportation to work (car/bus/train, walking/bicycling or work from home) and duration of transportation (minutes/day).
Measured: 0 minutes (fasting)
Night eating
Assessed using the Night Eating Questionnaire. The questionnaire covers hunger and craving for foods at different times during the day and night. The response format is a Likert-type scale ranging from e.g. 0=not at all to 4=very much.
Measured: Minimum 6 hours after test day
Eating behavior
Assessed using the Dutch Eating Behavior Questionnaire. The questionnaire consists of 33 questions and assess restrained (10 items), emotional (13 item), and external (10 items) eating behavior. The response format is a Likert-type scale ranging from 1=never to 5= very often. The greater the total score within each category the greater degree of e.g. dietary restraint.
Measured: Minimum 6 hours after test day
Control over eating
Assessed using the Control Over Eating Questionnaire. Control of eating and the degree of food cravings are assessed using the 21-item questionnaire which includes questions related to food cravings, control of eating, appetite and overall mood. Based on the previous 7 days, participants are asked to rate 20 questions on a 100 mm visual analogue scale (VAS). One question is open-ended. The VAS range is 0-100 and each end represent the extremes e.g. "how difficult is it to control eating": "Not difficult at all" to "It has never been more difficult".
Measured: Minimum 6 hours after test day
Socioeconomic status
Assessed using a questionnaire assessing self-reported educational level (categorical), main occupation (categorical), civil status (categorical), ethnicity (categorical), living arrangement (categorical), children (n), personal income (DKK), household income (DKK), sex (male/female), and age (years).
Measured: 0 minutes (fasting)
Total energy intake (kcal or kJ)
Total energy intake during an ad libitum buffet meal provided after all basal assessments
Measured: 60 minutes after basal assessments
Energy intake from specific food categories (kcal or kJ)
Energy intake from different food categories (high fat-savoury, high fat-sweet, low fat-savoury, low fat-sweet) during an ad libitum buffet meal provided after all basal assessments
Measured: 60 minutes after basal assessments
Explicit liking
Explicit liking of 8 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined during an ad libitum buffet meal provided after all basal assessments. Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes. Question: "how pleasant is the taste of the food right now?" Answer: "not pleasant at all" (rated 0 on the 0-100 scale) to "very pleasant" (rated 100 on the 0-100 scale).
Measured: 60 minutes after basal assessments
Explicit wanting
Explicit wanting of 8 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined during ad libitum buffet meal provided after all basal assessments. Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes. Question: "How much more do you think you can eat of the food right now?" Answer: "nothing at all" (rated 0 on the 0-100 scale) to "very much" (rated 100 on the 0-100 scale).
Measured: 60 minutes after basal assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start16 Oct 2018
- Primary completion29 Aug 2019
- Study completion29 Aug 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, University of Leeds, Aalborg University Hospital, IMotions A/S
- Responsible party
- Sponsor
- Investigators
- Kristine Færch, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986619
- Sponsor's protocol ID
- H-18026293_substudy
- Acronym
- PRESET
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedersen H, Diaz LJ, Clemmensen KKB, Jensen MM, Jorgensen ME, Finlayson G, Quist JS, Vistisen D, Faerch K. Predicting Food Intake from Food Reward and Biometric Responses to Food Cues in Adults with Normal Weight Using Machine Learning. J Nutr. 2022 Jun 9;152(6):1574-1581. doi: 10.1093/jn/nxac053.
PubMed 35325189
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Methods for Measuring Food Reward and Food-related Behavior in Healthy Individuals - a Substudy of the PRESET Study
- ClinicalTrials.gov ID
- NCT03986619
- Acronym / sponsor ID
- PRESET / H-18026293_substudy
- Conditions
- Healthy Participants
- Keywords
- Food preferences, Food reward
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen, University of Leeds, Aalborg University Hospital, IMotions A/S
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 14 Jun 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.
Most of the decisions and actions affecting energy balance are driven by implicit and explicit motivational processes. In modern obesogenic environment where highly palatable and energy-dense foods are easily available, it is of great interest to increase the understanding of both implicit and explicit processes of food-related behavior.
The aim of the present study is to examine whether biometric signatures in response to visual food stimuli during the already validated Leeds Food Preference Questionnaire (LFPQ) correlate with liking, wanting, food choice, or subsequent ad libitum food intake of those foods as assessed by the LFPQ and an ad libitum buffet meal.
Detailed description
Human behaviour including food reward plays a pivotal role in appetite regulation and the type and amount of food eaten. Food reward is a driver of eating behaviour and is defined as the momentary value of a food to the individual at the time of ingestion. Food reward contains the components of liking and wanting that can exist both with (explicit) and without (implicit) conscious awareness. Most of the daily decisions and actions affecting energy balance are driven by the non-conscious mind. Non-conscious processes are characterised by being unintentional and without awareness of the effects of triggering stimuli, e.g. food items. Contrary, conscious processes are typically assessed through participants' self-reports but limited by accuracy and desire to provide socially desirable answers. In a world of plenty where foods are always easily available with an overtly representation of highly palatable and energy-dense foods it is of great interest to understand the role of the non-conscious mind as a driver of food choice and intake. Intake of highly palatable and energy-dense foods is related to excess energy intake, high body mass index and weight gain. A possible explanation for this is that these foods are overall more rewarding and as a result of this, palatable.
A few previous studies have applied the use of innovative biometric measures, i.e. eye tracking, galvanic skin response, and facial expression to examine behavioural aspects of food intake that are without conscious awareness. However, there is a lack of studies examining how biometric responses to different food groups varying in energy density and palatability correlate with outcomes related to components of food reward and food intake. Therefore, in the present explorative study the above-mentioned biometric measurements will be combined with an existing validated method, the Leeds Food Preference Questionnaire (LFPQ), developed to examine both non-conscious and conscious components of food reward. The LFPQ assess four factors related to food reward within four combined food categories: food choice, implicit and explicit wanting, and explicit liking for high-fat sweet foods, low-fat sweet foods, high-fat savoury foods, and low-fat savoury foods. Biometric measurements of eye tracking can provide measures of attention, measurements of galvanic skin response can provide measures of arousal, and facial expressions analyses can provide information on emotional responses in response to selected stimuli, which in this study constitute pictures of food items. Furthermore, the study will include a taste task including an ad libitum intake of test foods in order to examine responses to actual food intake and to compare these responses to biometric responses to visual food stimuli.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal-weight individuals
Key inclusion criteria (2 listed)
- Age: from ≥30 to ≤70 years of age
- BMI: from 18.5 to 24.9 kg/m2
Key exclusion criteria (4 listed)
- Unable to understand the informed consent and the study procedures;
- Allergic to the food items included in the taste test
- Self-reported history of an eating disorder in the past three years
- Self-reported weight change (>5 kg) within three months prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gaze duration bias (ratio)
Time frame: 0 minutes (fasting)
A measure of attention measured using eye tracking in response to looking at food pictures during the computerized Leeds Food Preference Questionnaire. Gaze duration bias is calculated as the average gaze duration (ms) to a specific food image relative to the average gaze duration to all images. A bias score ˃0.5 indicates maintained attention towards a food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates maintained attention towards the other food images.
33 secondary outcomes
Attention
Time frame: 0 minutes (fasting)
Arousal
Time frame: 0 minutes (fasting)
Emotions
Time frame: 0 minutes (fasting)
Food choice
Time frame: 0 minutes (fasting)
Reaction time (ms)
Time frame: 0 minutes (fasting)
Implicit wanting
Time frame: 0 minutes (fasting)
Explicit liking
Time frame: 0 minutes (fasting)
Explicit wanting
Time frame: 0 minutes (fasting)
Subjective appetite
Time frame: 0 minutes (fasting)
Body weight (kg)
Time frame: 0 minutes (fasting)
Body mass index (kg/m^2)
Time frame: 0 minutes (fasting)
Fat mass (kg)
Time frame: 0 minutes (fasting)
Fat percentage (%)
Time frame: 0 minutes (fasting)
Fat free mass (kg)
Time frame: 0 minutes (fasting)
Waist circumference (cm)
Time frame: 0 minutes (fasting)
Hip circumference (cm)
Time frame: 0 minutes (fasting)
Systolic blood pressure (mmHg)
Time frame: 0 minutes (fasting)
Diastolic blood pressure (mmHg)
Time frame: 0 minutes (fasting)
Heart rate (bpm)
Time frame: 0 minutes (fasting)
HbA1c (mmol/mol and %)
Time frame: 0 minutes (fasting)
Sleep quality
Time frame: 0 minutes (fasting)
Sleepiness
Time frame: 0 minutes (fasting)
Self-reported health
Time frame: 0 minutes (fasting)
Physical activity
Time frame: Minimum 6 hours after test day
Chronotype
Time frame: 0 minutes (fasting)
Night eating
Time frame: Minimum 6 hours after test day
Eating behavior
Time frame: Minimum 6 hours after test day
Control over eating
Time frame: Minimum 6 hours after test day
Socioeconomic status
Time frame: 0 minutes (fasting)
Total energy intake (kcal or kJ)
Time frame: 60 minutes after basal assessments
Energy intake from specific food categories (kcal or kJ)
Time frame: 60 minutes after basal assessments
Explicit liking
Time frame: 60 minutes after basal assessments
Explicit wanting
Time frame: 60 minutes after basal assessments
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 4 Sep 2019.
- Derived from this study: PubMed 35325189Pedersen H, Diaz LJ, Clemmensen KKB, Jensen MM, Jorgensen ME, Finlayson G, Quist JS, Vistisen D, Faerch K. Predicting Food Intake from Food Reward and Biometric Responses to Food Cues in Adults with Normal Weight Using Machine Learning. J Nutr. 2022 Jun 9;152(6):1574-1581. doi: 10.1093/jn/nxac053.
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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?
An observational study of Healthy Participants, run by Steno Diabetes Center Copenhagen 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 2 inclusion and 4 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 4 Sep 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?
Gaze duration bias (ratio) (time frame: 0 minutes (fasting)). 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 NCT03986619, 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 4 Sep 2019.