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

Food Intake and Intra-Nasal Insulin for African American Adults

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.

Study Overview

• Status: Completed
• Conditions: Insulin
• Intervention / Treatment: Drug: Insulin, Regular, Human; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Novolin R
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: Saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Nutrition Obesity Research Center
• Investigators: Principal Investigator: Owen T Carmichael, Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: African American; Cognition; Intranasal Insulin; Food Intake; APOE
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: PBRC 2020-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study data will be available upon request with the appropriate data transfer agreements established.
• IPD Sharing Time Frame: The data will be available after the primary results of the study have been published.
• IPD Sharing Access Criteria: By request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No