Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)

Study Overview
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Brief Summary
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The purpose of this research study is to investigate brain insulin's relationship with food intake in African Americans. Facilitating insulin's entrance into the brain through a nasal spray is currently being studied as a way to prevent or treat Alzheimer's disease. However, brain insulin may also have an impact on food intake. This study is designed to help researchers understand how different factors related to Alzheimer's disease (i.e. APOE genotype and cognitive functioning) influence brain insulin's relationship with food intake.

Detailed Description
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The investigators will utilize a double-blind, placebo-controlled, randomized crossover design comparing a single acute dose of intranasal insulin to a single acute dose of a saline placebo. The primary aim will consist of exploring the differences in ingestive behaviors constructs (i.e. hunger, satiety, and fullness) and ad libitum lunch caloric intake between acute administration of either a dose of intranasal insulin or saline placebo. The hypothesis is that acute intranasal insulin will result in the consumption of fewer calories, greater feelings of satiety and fullness, and less hunger compared to acute saline. A secondary aim of this investigation will be to analyzing differences in food intake by APOE genotype, adiposity, and AD family history.

Official Title
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Food Intake and Intra-Nasal Insulin for African American Adults

Conditions
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Insulin

Intervention / Treatment
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* Drug: Insulin, Regular, Human
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-identify as African American are aged 45 years to 65 years old are willing to provide written informed consent speak and read English Exclusion Criteria: diagnosed with type 1 or 2 diabetes pregnant or attempting to become pregnant have a history of sensitivity to glutaraldehyde

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch. | Drug: Insulin, Regular, Human<br>* The spray will last a few seconds and then the participant will be asked to sniff to aid the drug into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.<br>* Other names: Novolin R;|
| Placebo Comparator: Placebo<br>40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch. | Drug: Placebo<br>* The spray will last a few seconds and then the participant will be asked to sniff to aid the saline into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caloric intake | Caloric intake will be quantified by measuring the amount of the ad libitum lunch that is consumed. Caloric intake will be compared between insulin and placebo conditions to determine if caloric intake has increased or decreased. | 30 minutes post intranasal insulin administration | 
| Change in ingestive behavior constructs | Ingestive behavior constructs (e.g. hunger, satiety, fullness, etc.) will be quantified through the use of visual analogue scales that have a positive and negative rating at each end attached to a specific question to address each construct separately. Ingestive behavior outcomes will be compared between insulin and placebo conditions to determine if there are greater or lesser feelings of ingestive behavior constructs. | 30 minutes post intranasal insulin administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who are APOE e4 carriers versus noncarriers | APOE genotype (i.e. APOE e4 carriers versus noncarriers) will be identified via blood assay. | Through study completion, an average of 1 year | 
| Characterize AD family history (via a questionnaire) | AD family history, via a questionnaire, will be quantified by asking participants to identify immediate biological family members that have suffered from AD or dementia. | Day 1 | 
| Amount of adiposity (i.e. DXA) per participant | Adiposity will be quantified via a DXA scan. | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intranasal Insulin, APOE, Food Intake, Cognition, African American