Skip to main content
OpenTrials
Completed

NCT Number: NCT03632681

Effect of Intranasal Insulin on Cognitive Processes and Appetite

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Univerisity of Birmingham

Birmingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal insulin

Drug

Intranasal insulin

Other names: Insulin, Actrapid

Intranasal placebo

Drug

Intranasal placebo manufactured to mimic smell of insulin

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. fMRI brain activity in food picture task

    Time frame: 18 minutes

    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.

  4. 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)

  5. Recall words

    Time frame: 10 minutes

    Recall words. The researcher will count the correct amount of words remembered in this task

  6. Emotional categorisation

    Time frame: 10 minutes

    Accuracy of category and reaction time will be measured for dislike or like words

  7. Emotional recall part 1

    Time frame: 4 minutes

    Recall words of liked and disliked words will be recorded in ECAT

  8. Emotional recall part 1

    Time frame: 10 minutes

    Accuracy of previous exposed or not exposed words will be measured

  9. Cookie intake

    Time frame: 10 minutes

    Amount (kcal and gram) of cookies eaten will be measured

  10. fMRI neural network during inhibition to a food stimuli

    Time frame: 14 minutes

    Functional connectivity during correct inhibition food vs. non-food stimuli trail.

  11. 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

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Queen Elizabeth Hospital NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2018
Registry last updated
May 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.