Food Intake and Intra-Nasal Insulin for African American Adults (FIINAAL)
NCT ID: NCT04739371
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2021-06-17
2022-06-07
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Insulin
40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch.
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.
Placebo
40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* are aged 45 years to 65 years old
* are willing to provide written informed consent
* speak and read English
Exclusion Criteria
* pregnant or attempting to become pregnant
* have a history of sensitivity to glutaraldehyde
45 Years
65 Years
ALL
Yes
Sponsors
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Nutrition Obesity Research Center
OTHER
Pennington Biomedical Research Center
OTHER
Responsible Party
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Owen Carmichael
Principal Investigator
Principal Investigators
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Owen T Carmichael, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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Other Identifiers
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PBRC 2020-047
Identifier Type: -
Identifier Source: org_study_id