Dietary Oil to Improve Sleep Quality: SNACk Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Changes in activity during waking and sleeping hours using an actigraph
研究概览
简要总结
The purpose of this study is to identify if healthy cookies high in linoleic acid can change sleep quality and sleep architecture, blood fatty acid composition and be consumed with high compliance after eight weeks of consumption. The hypothesis is that consumption of healthy cookies for 8 weeks will improve sleep quality, increase linoleic acid in the blood and be consumed with greater than 80% compliance.
详细描述
Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, but is not clear if linoleic acid consumption can influence sleep quality.
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following specific aims
Aim 1) To determine the effect of healthy cookies made with linoleic acid-rich oil on measures of sleep quality and sleep architecture in overweight adults
Aim 2) To determine the effect on plasma fatty acid composition and markers of circadian rhythm in peripheral blood mononuclear cells (PBMC) after four and eight weeks of consuming one healthy cookie per day
Aim 3) To measure the effect of healthy cookies made with LA-oil on change of lipidomic profiles of plasma and PBMC after four and eight weeks of consumption
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight (BMI ≥25 and <38)
- •Nonsmoker
- •Insomnia severity index score ≥8
排除标准
- •Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer
- •Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
- •Food Allergy or Intolerance
- •Any dietary restriction where consumption of these healthy cookies or any ingredient would be contraindicated
- •Use of medications where consuming the healthy cookies would be contraindicated
- •Usage of sleep aid (prescription medication(s)) for insomnia
- •Pregnancy
结局指标
主要结局
Changes in activity during waking and sleeping hours using an actigraph
时间窗: Week 0, week 4 and week 8
Changes in activity during waking and sleeping hours each day will be measured using actigraphy
Changes in sleep quality using the Pittsburgh Sleep quality index, PROMIS Sleep questionnaire, and insomnia severity index questionnaire
时间窗: Week 0, week 4 and week 8
Changes in global sleep quality scores using the Pittsburgh sleep quality index PROMIS Sleep questionnaire, and insomnia severity index measurements
Changes in blood fatty acids
时间窗: Week 0, week 4 and week 8
Changes in linoleic acid levels in the blood
Changes in markers of circadian rhythm
时间窗: Week 0, week 4 and week 8
Changes in mRNA expression of genes related to circadian rhythm in peripheral blood mononuclear cells
Changes in blood lipidomic profiles
时间窗: Week 0, week 4 and week 8
Changes in linoleic acid oxylipins in plasma and cardiolipin in peripheral blood mononuclear cells
Feasibility of daily healthy cookie consumption
时间窗: Week 8
Percent of healthy cookies consumed
Changes in sleep electroencephalography (EEG)
时间窗: Week 0, week 4 and week 8
Changes in sleep EEG will be measured to determine sleep efficiency, arousal index, total sleep time
次要结局
- Changes in body shape using body mass index (calculated using height and weight) and abdominal thickness(Week 0 and week 8)
- Changes in markers of muscle function using gait speed and grip strength(Week 0 and week 8)
- Changes in marker of glycemia(Week 0, week 4 and week 8)
- Changes in markers of inflammation(Week 0, week 4 and week 8)
研究者
Martha Belury
Associate Professor
Ohio State University