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

NCT04739371 | Completed Phase 1 FDA Drug

• 1 other identifier: PBRC 2020-047
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulin

Keywords

Intranasal Insulin; Food Intake; APOE; Cognition; African American

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of participants who are APOE e4 carriers versus noncarriers

  Through study completion, an average of 1 year

• Characterize AD family history (via a questionnaire)

  Day 1

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

  Day 4

Study Arms (2)

Insulin

EXPERIMENTAL

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

Drug: Insulin, Regular, Human

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: Novolin R

Insulin

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.

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as African American
• are aged 45 years to 65 years old
• are willing to provide written informed consent
• speak and read English

You may not qualify if:

• diagnosed with type 1 or 2 diabetes
• pregnant or attempting to become pregnant
• have a history of sensitivity to glutaraldehyde

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Nutrition Obesity Research Center: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Insulin, Regular, Human; Insulin; Sodium Chloride

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Owen T Carmichael, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 4, 2021
• Study Start: June 17, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available after the primary results of the study have been published.
• Access Criteria: By request

Locations

US (1)