Effect of Intranasal Insulin on Cognitive Processes and Appetite

U

University of Birmingham

Status

Completed

Conditions

Obesity

Treatments

Drug: Intranasal Insulin
Drug: Intranasal Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03632681
RG_17-102

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

64 participants in 2 patient groups, including a placebo group

Insulin
Active Comparator group
Description:
In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated
Treatment:
Drug: Intranasal Insulin
Placebo
Placebo Comparator group
Description:
In this arm a single-dose intranasal placebo will be administrated
Treatment:
Drug: Intranasal Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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