Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nutrition Obesity Research Center | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | Experimental | 40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch. |
|
| Placebo | Placebo Comparator | 40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Owen T Carmichael, Ph.D. | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
The study data will be available upon request with the appropriate data transfer agreements established.
Not provided
The data will be available after the primary results of the study have been published.
By request
Not provided
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061386 | Insulin, Regular, Human |
| D007328 | Insulin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |