Food Intake and Intra-Nasal Insulin for African American Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in ingestive behavior constructs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identify as African American
- •are aged 45 years to 65 years old
- •are willing to provide written informed consent
- •speak and read English
排除标准
- •diagnosed with type 1 or 2 diabetes
- •pregnant or attempting to become pregnant
- •have a history of sensitivity to glutaraldehyde
研究组 & 干预措施
Insulin
40 participants will receive 40 IUs of intranasal insulin about 30 minutes before consuming an ad libitum lunch.
干预措施: Insulin, Regular, Human (Drug)
Placebo
40 participants will receive 40 IUs of intranasal saline about 30 minutes before consuming an ad libitum lunch.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in ingestive behavior constructs
时间窗: 30 minutes post intranasal insulin administration
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.
Change in caloric intake
时间窗: 30 minutes post intranasal insulin administration
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.
次要结局
- Characterize AD family history (via a questionnaire)(Day 1)
- Amount of adiposity (i.e. DXA) per participant(Day 4)
- Number of participants who are APOE e4 carriers versus noncarriers(Through study completion, an average of 1 year)
研究者
Owen Carmichael
Principal Investigator
Pennington Biomedical Research Center