Eating BehaviorNCT03472703
Effect of Consumption on Cognitive Processes
A study testing Break-Lunch time in people with Eating Behavior and Hunger, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
To get a better understanding of the interaction between metabolism, neural responses, cognitive processes and appetite the investigaters will examine the effect of food consumption on cognitive processes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Hunger, Inhibition
- What is being tested?
- Break-Lunch time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2017to 10 Apr 2018
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Age 18-45 years at start of the study
- Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- Ability to give informed consent
- Fluent English speaking
- Willingness to be informed about chance findings of pathology
Who cannot join
- Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Pathological hearing ability or an increased sensitivity to loud noises
- Lack of ability to give informed consent
- Operation less than three months ago
Show all 17Show fewer
- Acute illness or infection during the last 4 weeks
- Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome)
- Moderate or severe head injury
- Eating disorders
- No metabolic (e.g. metabolic disorder, diabetes, insulin resistance), psychological (e.g. depression) or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases.
- Current weight loss regimens, or more then 5kg weight loss in the last 3 months
- Smoking
- Current pregnancy or breastfeeding
- Current or past history of drug or alcohol dependency - alcohol consumption exceeding 12 units a week
- Food allergies (e.g. peanut allergy lactose and gluten intolerance) or vegetarian/vegan diet
- Disliking the study lunch
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Birmingham School of Psychology
Birmingham, Midlands, B15 2TT
About this study
To get a better understanding of the interaction between metabolism, neural responses, cognitive processes and appetite the investigaters will examine the effect of food consumption on cognitive processes. The investigaters will look at the effect of satiation on cognitive performance on both a behavioural and neuronal level. In this study participants will undergo functional magnetic resonance imaging (fMRI) measurements while performing a food reward and inhibition task, and in addition perform a memory, working memory and delay discount task, once when hungry and once when full.
Read the detailed description
Human eating behaviour is a very complex process. It has been well established that food intake and choice are influences by nutritional composition of the food and their reward values. However recent work suggests that cognitive processes such as memory, attention, and inhibition influence food choices. Thinking about food can lead to increased attention to food cues, which can result in a greater chance of actual food consumption. Additional manipulation of attention effects memory and snack intake. It has been suggested that memory inhibition plays a critical role in suppression of food-related information when satiated to prevent overeating. These results underpin the interaction between cognitive processes and internal state and its effect on appetite. Although it has been widely studied what the effect of satiation is on reward and even which brain regions are associated with food intake, for both homeostatic and hedonic eating, the direct effect of consumption on cognitive processes and the related brain processes are rather unknown.
In this study participants will be asked to come to a research facility twice (within-design). Once the particpant will undergo all the tasks when hungry and receive a lunch at the end of the study-day (hungry session), and once the subject will first receive a lunch and then perform all the tasks (satiated session). Upon arrival subjects will fill in their appetite and mood ratings, followed by a break or a lunch (depending on the session). After the 25-min break/lunch the subject will be placed in the scanner. First the particpants neural responses will be measure while performing an inhibition task, here subjects will complete a go-no/go task; the particpant either has to go (press) when seeing a toiletry or stationary item, or not go (withhold pressing) when seeing a food or sports item. Second a resting state fMRI measurement will be performed. Third subjects will see food and non-food items, which the particpant has to rate on their appeal. Last an anatomical scan will be run. When out of the scanner subjects will undergo several cognitive computerized tasks, a word recall task, a working memory task (measuring the top-down guidance of attention to food stimuli via working memory) and a delay discount task. At last subjects will get lunch (when receiving a break at the start) or a break (when consuming food at arrival).
- Being tested
- Break-Lunch time
- Keywords
- fMRI, Cognitive processes, Inhibition, Food reward, Appetite
- Medical subject headings
- Feeding Behavior, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Break-Lunch timeOther
The time for the break and lunch will be contrary, depending on their visit/session
| Study group | Role | What they receive |
|---|---|---|
| Hungry | Other | Her subjects will first have a break, then undergo all measurement and at the end of the study-day they will receive their lunch Receives: Other: Break-Lunch time |
| Satiated | Other | Her subjects will first receive their lunch, then perform all the tasks and last will have a break Receives: Other: Break-Lunch time |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI brain responses during inhibition
- Neural activation correct No-Go vs. Go trail. Subjects neural activation when they are instructed to go (press) when seeing toiletry or stationary items and react correctly compared to when subjects are instructed not to go (no press) when seeing a food or sport and withhold correctly
Measured: 14 minutes
fMRI brain repsonse during inhibition to a food stimuli
Neural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.
Measured: 14 minutes
fMRI neural network during inhibition to a food stimuli
Functional connectivity during correct inhibition food vs. non-food stimuli trail.
Measured: 14 minutes
Secondary outcomes (5)
Word recall
Recall accuracy. The researchers will count the correct amount of words remembered in this task and calculate % of words remembered in total, and differentiate between the three categories (food/neutral/emotional)
Measured: 10 minutes
Delay discount of food reward
- Area under the curve for delay of choosing a food item. Subjects have to choice between a certain amount of food now, or more (which varies between 1-20 pieces) food later (which will vary from 1 day, 1 months and 1 year).
Measured: 10 minutes
Delay discount of money reward
- Area under the curve for delay of choosing a amount of money. Subjects have to choice between a certain amount of money now, or more (which varies between 1-100 pound) money later (which will vary from 1 day, 1 months and 1 year).
Measured: 10 minutes
Reaction time to target
Particpants have to hold a food or non-food image in working memory for later retrieval. Subsequently, particpants have to respond to a target and ignore a distracter, both paired with an image. As a outcome there are three reaction time critical conditions (i) valid trials, when the memorized item appeared next to the search target; (ii) invalid trials, when the memorized item appeared next to a distracter in the search display; (iii) neutral trials in which the memorized item did not re-appear in the search display. The
Measured: 25 minutes
fMRI brain activity in food picture task
- Brain responses for food stimuli compared to non-food stimuli. We will measure this by showing subjects food and non-food images while preforming and fMRI-scan and subtract activity during non-food images from the activity pattern when looking at food images.
Measured: 18 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start1 Jul 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We will use a counter-balanced, crossover, within-subject design
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maartje S Spetter, PhD, Principal investigator, UoB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472703
- Sponsor's protocol ID
- ERN_10-0014AP7
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption on Cognitive Processes
- ClinicalTrials.gov ID
- NCT03472703
- Acronym / sponsor ID
- ERN_10-0014AP7
- Keywords
- fMRI, Cognitive processes, Inhibition, Food reward, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 21 Mar 2018 (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.
To get a better understanding of the interaction between metabolism, neural responses, cognitive processes and appetite the investigaters will examine the effect of food consumption on cognitive processes. The investigaters will look at the effect of satiation on cognitive performance on both a behavioural and neuronal level. In this study participants will undergo functional magnetic resonance imaging (fMRI) measurements while performing a food reward and inhibition task, and in addition perform a memory, working memory and delay discount task, once when hungry and once when full.
Detailed description
Human eating behaviour is a very complex process. It has been well established that food intake and choice are influences by nutritional composition of the food and their reward values. However recent work suggests that cognitive processes such as memory, attention, and inhibition influence food choices. Thinking about food can lead to increased attention to food cues, which can result in a greater chance of actual food consumption. Additional manipulation of attention effects memory and snack intake. It has been suggested that memory inhibition plays a critical role in suppression of food-related information when satiated to prevent overeating. These results underpin the interaction between cognitive processes and internal state and its effect on appetite. Although it has been widely studied what the effect of satiation is on reward and even which brain regions are associated with food intake, for both homeostatic and hedonic eating, the direct effect of consumption on cognitive processes and the related brain processes are rather unknown.
In this study participants will be asked to come to a research facility twice (within-design). Once the particpant will undergo all the tasks when hungry and receive a lunch at the end of the study-day (hungry session), and once the subject will first receive a lunch and then perform all the tasks (satiated session). Upon arrival subjects will fill in their appetite and mood ratings, followed by a break or a lunch (depending on the session). After the 25-min break/lunch the subject will be placed in the scanner. First the particpants neural responses will be measure while performing an inhibition task, here subjects will complete a go-no/go task; the particpant either has to go (press) when seeing a toiletry or stationary item, or not go (withhold pressing) when seeing a food or sports item. Second a resting state fMRI measurement will be performed. Third subjects will see food and non-food items, which the particpant has to rate on their appeal. Last an anatomical scan will be run. When out of the scanner subjects will undergo several cognitive computerized tasks, a word recall task, a working memory task (measuring the top-down guidance of attention to food stimuli via working memory) and a delay discount task. At last subjects will get lunch (when receiving a break at the start) or a break (when consuming food at arrival).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will use a counter-balanced, crossover, within-subject design
| Arm | Type | Receives |
|---|---|---|
| Hungry | Other | Other: Break-Lunch timeHer subjects will first have a break, then undergo all measurement and at the end of the study-day they will receive their lunch |
| Satiated | Other | Other: Break-Lunch timeHer subjects will first receive their lunch, then perform all the tasks and last will have a break |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy subjects
- Age 18-45 years at start of the study
- Right-handedness (including left-handers could bias the results because of the laterality of brain functions)
- Ability to give informed consent
- Fluent English speaking
Key exclusion criteria (17 listed)
- Subjects who have a non-removable metal object in or at their body, such as, for example: Heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Tattoos, that are older than 15 years
- Claustrophobia
- Pathological hearing ability or an increased sensitivity to loud noises
- Lack of ability to give informed consent
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 |
|---|---|---|
| Break-Lunch timeThe time for the break and lunch will be contrary, depending on their visit/session | Other | Hungry, Satiated |
Primary outcome
fMRI brain responses during inhibition
Time frame: 14 minutes
- Neural activation correct No-Go vs. Go trail. Subjects neural activation when they are instructed to go (press) when seeing toiletry or stationary items and react correctly compared to when subjects are instructed not to go (no press) when seeing a food or sport and withhold correctly
fMRI brain repsonse during inhibition to a food stimuli
Time frame: 14 minutes
Neural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.
fMRI neural network during inhibition to a food stimuli
Time frame: 14 minutes
Functional connectivity during correct inhibition food vs. non-food stimuli trail.
5 secondary outcomes
Word recall
Time frame: 10 minutes
Delay discount of food reward
Time frame: 10 minutes
Delay discount of money reward
Time frame: 10 minutes
Reaction time to target
Time frame: 25 minutes
fMRI brain activity in food picture task
Time frame: 18 minutes
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 3 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
Maartje S Spetter, PhD principal investigator
UoB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Break-Lunch time in people with Eating Behavior and Hunger, run by University of Birmingham at 1 site in United Kingdom.
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 6 inclusion and 17 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 3 May 2018. 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 United Kingdom. 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?
fMRI brain responses during inhibition (time frame: 14 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.