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

Pennington Biomedical Research Center

Status and phase: Completed; Phase 1

Conditions: Insulin

Treatments: Drug: Insulin, Regular, Human; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04739371

PBRC 2020-047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Insulin

Experimental group

Description:

40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch.

Treatment:

Drug: Insulin, Regular, Human

Placebo

Placebo Comparator group

Description:

40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch.

Treatment:

Drug: Placebo