ObesityNCT03632681
Effect of Intranasal Insulin on Cognitive Processes and Appetite
A study testing Intranasal Insulin in people with Obesity, run by University of Birmingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intranasal Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Intranasal Insulin, Intranasal Placebo
- Keywords
- Cognitive processes, Reward processes, fMRI, Insulin
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
Also called Insulin, Actrapid
Intranasal insulin
Intranasal PlaceboDrug
Also called Placebo
Intranasal placebo manufactured to mimic smell of insulin
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Active comparator | In this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated Receives: Drug: Intranasal Insulin |
| Placebo | Placebo comparator | In this arm a single-dose intranasal placebo will be administrated Receives: Drug: Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 minutes
Secondary outcomes (11)
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).
Measured: 5 minutes
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).
Measured: 5 minutes
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.
Measured: 18 minutes
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)
Measured: 5 minutes
Recall words
Recall words. The researcher will count the correct amount of words remembered in this task
Measured: 10 minutes
Emotional categorisation
Accuracy of category and reaction time will be measured for dislike or like words
Measured: 10 minutes
Emotional recall part 1
Recall words of liked and disliked words will be recorded in ECAT
Measured: 4 minutes
Emotional recall part 1
Accuracy of previous exposed or not exposed words will be measured
Measured: 10 minutes
Cookie intake
Amount (kcal and gram) of cookies eaten will be measured
Measured: 10 minutes
fMRI neural network during inhibition to a food stimuli
Functional connectivity during correct inhibition food vs. non-food stimuli trail.
Measured: 14 minutes
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
Measured: 14 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start23 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Maartje SPetter, PhD, Principal investigator, Univerisity of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632681
- Sponsor's protocol ID
- RG_17-102
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and data will be shared on Open Science Forum
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Metabolic, Cognitive and Reward Processes in Appetite - Effects of Intranasal Administration of Insulin
- ClinicalTrials.gov ID
- NCT03632681
- Acronym / sponsor ID
- RG_17-102
- Conditions
- Obesity
- Keywords
- Cognitive processes, Reward processes, fMRI, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Queen Elizabeth Hospital NHS Foundation Trust
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Active comparator | Drug: Intranasal InsulinIn this arm a single-dose of (160 IU/1.6ml) intranasal insulin will be administrated |
| Placebo | Placebo comparator | Drug: Intranasal PlaceboIn this arm a single-dose intranasal placebo will be administrated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal InsulinAlso: Insulin, ActrapidIntranasal insulin | Drug | Insulin |
| Intranasal PlaceboAlso: PlaceboIntranasal placebo manufactured to mimic smell of insulin | Drug | Placebo |
Primary outcome
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.
11 secondary outcomes
Delay discount of food reward
Time frame: 5 minutes
Delay discount of money reward
Time frame: 5 minutes
fMRI brain activity in food picture task
Time frame: 18 minutes
Recall pictures
Time frame: 5 minutes
Recall words
Time frame: 10 minutes
Emotional categorisation
Time frame: 10 minutes
Emotional recall part 1
Time frame: 4 minutes
Emotional recall part 1
Time frame: 10 minutes
Cookie intake
Time frame: 10 minutes
fMRI neural network during inhibition to a food stimuli
Time frame: 14 minutes
fMRI brain responses during inhibition
Time frame: 14 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: Yes. The study protocol and data will be shared on Open Science Forum
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maartje SPetter, PhD principal investigator
Univerisity of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal Insulin in people with Obesity, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI brain response during inhibition to a food stimuli (time frame: 14 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.