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

Insulin Clinical Trial

— FIINAAL  

Official title:

Food Intake and Intra-Nasal Insulin for African American Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739371
• Other study ID #: PBRC 2020-047
• Status: Completed
• Phase: Phase 1
• Start date: June 17, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Nutrition Obesity Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Amount of adiposity (i.e. DXA) per participant	Adiposity will be quantified via a DXA scan.	Day 4