- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03632681
Effect of Intranasal Insulin on Cognitive Processes and Appetite
Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Birmingham, United Kingdom
- Univerisity of Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Insulin
In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated
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Intranasal insulin
Other Names:
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Placebo Comparator: Placebo
In this arm a single-dose intranasal placebo will be administrated
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Intranasal placebo manufactured to mimic smell of insulin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI brain response 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.
|
14 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay discount of food reward
Time Frame: 5 minutes
|
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
Time Frame: 5 minutes
|
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
Time Frame: 18 minutes
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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.
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18 minutes
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Recall pictures
Time Frame: 5 minutes
|
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)
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5 minutes
|
Recall words
Time Frame: 10 minutes
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Recall words.
The researcher will count the correct amount of words remembered in this task
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10 minutes
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Emotional categorisation
Time Frame: 10 minutes
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Accuracy of category and reaction time will be measured for dislike or like words
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10 minutes
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Emotional recall part 1
Time Frame: 4 minutes
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Recall words of liked and disliked words will be recorded in ECAT
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4 minutes
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Emotional recall part 1
Time Frame: 10 minutes
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Accuracy of previous exposed or not exposed words will be measured
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10 minutes
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Cookie intake
Time Frame: 10 minutes
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Amount (kcal and gram) of cookies eaten will be measured
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10 minutes
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fMRI neural network during inhibition to a food stimuli
Time Frame: 14 minutes
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Functional connectivity during correct inhibition food vs. non-food stimuli trail.
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14 minutes
|
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
|
14 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maartje SPetter, PhD, Univerisity of Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG_17-102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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