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Effect of Intranasal Insulin on Cognitive Processes and Appetite

Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03632681
Enrollment
64
Registered
2018-08-15
Start date
2018-04-23
Completion date
2019-04-01
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Cognitive processes, Reward processes, fMRI, Insulin

Brief summary

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.

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.

Interventions

DRUGIntranasal Insulin

Intranasal insulin

DRUGIntranasal Placebo

Intranasal placebo manufactured to mimic smell of insulin

Sponsors

Queen Elizabeth Hospital NHS Foundation Trust
CollaboratorOTHER
University of Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
fMRI brain response during inhibition to a food stimuli14 minutesNeural activation during correct inhibition food vs. non-food stimuli trail. Comparing the brain response when subjects correctly withhold for food vs a sports item.

Secondary

MeasureTime frameDescription
Delay discount of food reward5 minutesArea 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).
fMRI brain activity in food picture task18 minutesBrain 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.
Recall pictures5 minutesRecall 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)
Recall words10 minutesRecall words. The researcher will count the correct amount of words remembered in this task
Delay discount of money reward5 minutesArea 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).
Emotional recall part 14 minutesRecall words of liked and disliked words will be recorded in ECAT
Cookie intake10 minutesAmount (kcal and gram) of cookies eaten will be measured
fMRI neural network during inhibition to a food stimuli14 minutesFunctional connectivity during correct inhibition food vs. non-food stimuli trail.
fMRI brain responses during inhibition14 minutesNeural 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
Emotional categorisation10 minutesAccuracy of category and reaction time will be measured for dislike or like words

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026