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NCT Number: NCT04739371

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

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.

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Key information

Conditions

Insulin Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin, Regular, Human

Drug

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: Novolin R

Placebo

Drug

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: Saline

Primary outcomes

  1. Change in caloric intake

    Time frame: 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.

  2. Change in ingestive behavior constructs

    Time frame: 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 outcomes

  1. Number of participants who are APOE e4 carriers versus noncarriers

    Time frame: Through study completion, an average of 1 year

    APOE genotype (i.e. APOE e4 carriers versus noncarriers) will be identified via blood assay.

  2. Characterize AD family history (via a questionnaire)

    Time frame: 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.

  3. Amount of adiposity (i.e. DXA) per participant

    Time frame: Day 4

    Adiposity will be quantified via a DXA scan.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • Nutrition Obesity Research Center

Registry information

Official study title

Food Intake and Intra-Nasal Insulin for African American Adults

Acronym: FIINAAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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