An interventional study of Break-Lunch time in Eating Behavior, Hunger and Inhibition, sponsored by University of Birmingham. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by University of Birmingham · Not applicable, Interventional, and Basic science
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.
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).
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's enrollment of 31 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
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On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Her subjects will first have a break, then undergo all measurement and at the end of the study-day they will receive their lunch
Other: Break-Lunch time
Her subjects will first receive their lunch, then perform all the tasks and last will have a break
Other: Break-Lunch time
The time for the break and lunch will be contrary, depending on their visit/session
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
Time frame: 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.
Time frame: 14 minutes
fMRI neural network during inhibition to a food stimuli
Functional connectivity during correct inhibition food vs. non-food stimuli trail.
Time frame: 14 minutes
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)
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 18 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Apr 2018, 9 months.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 9 months is below that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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