Obesity Clinical Trial
Official title:
Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin
NCT number | NCT03632681 |
Other study ID # | RG_17-102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 23, 2018 |
Est. completion date | April 1, 2019 |
Verified date | August 2018 |
Source | University of Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | April 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy female subjects - Age 18-65 years at start of the study - Body Mass Index (BMI) between 18 and 25 kg/m2 for the lean group and between 30 and 40 kg/m2 for the obese group - 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 Exclusion Criteria: - 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 - Limited temperature perception and/or increased sensitivity to warming of the body - Pathological hearing ability or an increased sensitivity to loud noises - Lack of ability to give informed consent - Operation less than three months ago - Simultaneous participation in other studies that involve drugs intake or blood spending - 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. - Intake of any medication that can interfere with the drug or measurements. - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Univerisity of Birmingham | Birmingham |
Lead Sponsor | Collaborator |
---|---|
University of Birmingham | Queen Elizabeth Hospital NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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). | 5 minutes | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Recall words | Recall words. The researcher will count the correct amount of words remembered in this task | 10 minutes | |
Secondary | Emotional categorisation | Accuracy of category and reaction time will be measured for dislike or like words | 10 minutes | |
Secondary | Emotional recall part 1 | Recall words of liked and disliked words will be recorded in ECAT | 4 minutes | |
Secondary | Emotional recall part 1 | Accuracy of previous exposed or not exposed words will be measured | 10 minutes | |
Secondary | Cookie intake | Amount (kcal and gram) of cookies eaten will be measured | 10 minutes | |
Secondary | fMRI neural network during inhibition to a food stimuli | Functional connectivity during correct inhibition food vs. non-food stimuli trail. | 14 minutes | |
Secondary | 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 |
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