Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Insulin 40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch. |
Drug: Insulin, Regular, Human
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.
Other Names:
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| Placebo Comparator: Placebo 40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch. |
Drug: Placebo
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in caloric intake [30 minutes post intranasal insulin administration]
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.
- Change in ingestive behavior constructs [30 minutes post intranasal insulin administration]
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.
Secondary Outcome Measures
- Number of participants who are APOE e4 carriers versus noncarriers [Through study completion, an average of 1 year]
APOE genotype (i.e. APOE e4 carriers versus noncarriers) will be identified via blood assay.
- Characterize AD family history (via a questionnaire) [Day 1]
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.
- Amount of adiposity (i.e. DXA) per participant [Day 4]
Adiposity will be quantified via a DXA scan.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pennington Biomedical Research Center | Baton Rouge | Louisiana | United States | 70808 |
Sponsors and Collaborators
- Pennington Biomedical Research Center
- Nutrition Obesity Research Center
Investigators
- Principal Investigator: Owen T Carmichael, Ph.D., Pennington Biomedical Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PBRC 2020-047