Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Queen Elizabeth Hospital NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
This study investigates the effect of intranasal insulin on cognitive processes (behavioural and neural) in healthy lean and obese female adults. All subjects will receive a single-dose of intranasal insulin and/or placebo (on different days) before participating in several cognitive tasks.
It is well established that eating behaviour is affected by metabolic signals (e.g. insulin, ghrelin, serotonin) and is also modulated via food reward processes. However, in humans, eating behaviour is a complex process, which involves habits, long-term goals and social interaction. Thus, recently it has been proposed that higher cognitive processes such as inhibitory control, attention and memory also modulate eating.
Insulin seems to be involved in both metabolic processes and cognitive processes. In the last decade it has been shown that intranasal administration of insulin decreases food intake, especially in women, and enhances thermogenesis and memory. In addition intranasal insulin administration has been shown to affect brain areas related to homeostatic control, reward and memory.
In the proposed study the investigators will examine the effect of intranasal insulin administration on eating, and on metabolic, reward and cognitive processes and their potential interplay. The investigators will also study the effect of body weight on the actions of insulin on these processes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | Active Comparator | In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated |
|
| Placebo | Placebo Comparator | In this arm a single-dose intranasal placebo will be administrated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Insulin | Drug | Intranasal insulin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| fMRI brain response 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. | 14 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 hour to 1 year). | 5 minutes |
| Delay discount of money reward |
Not provided
Inclusion Criteria:
Exclusion Criteria:
based on self-representation of gender identity
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maartje SPetter, PhD | Univerisity of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity of Birmingham | Birmingham | United Kingdom |
The study protocol and data will be shared on Open Science Forum
The study protocol will be shared before including the first participant. The data will become available after the last participant has finished the study.
All researchers
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intranasal Placebo | Drug | Intranasal placebo manufactured to mimic smell of insulin |
|
|
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). |
| 5 minutes |
| fMRI brain activity in food picture task | Brain responses for food stimuli compared to non-food stimuli. The researchers 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. | 18 minutes |
| Recall pictures | Recall accuracy. The researchers will count the correct amount of pictures remembered in this task and calculate % of pictures remembered in total, and differentiate between the three categories (high caloric/low caloric/control) | 5 minutes |
| Recall words | Recall words. The researcher will count the correct amount of words remembered in this task | 10 minutes |
| Emotional categorisation | Accuracy of category and reaction time will be measured for dislike or like words | 10 minutes |
| Emotional recall part 1 | Recall words of liked and disliked words will be recorded in ECAT | 4 minutes |
| Emotional recall part 1 | Accuracy of previous exposed or not exposed words will be measured | 10 minutes |
| Cookie intake | Amount (kcal and gram) of cookies eaten will be measured | 10 minutes |
| fMRI neural network during inhibition to a food stimuli | Functional connectivity during correct inhibition food vs. non-food stimuli trail. | 14 minutes |
| 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 | 14 minutes |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |