The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Changes in fasting fatty acid levels
研究概览
简要总结
The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.
详细描述
Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin. It is therefore imperative to develop foods products that allow for Americans to easily increase their intake of linoleic acid. It's also important to understand the mechanism in which linoleic acid exerts these positive health effects, particularly in states of muscle mass and quality loss associated with mitochondria dysfunction.
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims
Aim 1: To determine the extent to which cookies, made with grapeseed oil , increase linoleic acid in plasma, red blood cells (RBCs), and peripheral blood mononuclear cells (PBMCs) fraction of blood after two weeks consumption
Aim 2: To determine the extent to which cookies, made with grapeseed oil, increase cardiolipin and linoleic acid content of cardiolipin in PBMCs after two weeks of consumption
Aim 3: To determine and compare the acceptability of consuming cookies made with grapeseed oil or high oleic safflower oil every day for two weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nonsmokers
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 & Bee allergy
- •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
- •Use of supplements/oils high in linoleic acid in the past 4 weeks prior to enrolling
- •Pregnancy
研究组 & 干预措施
High Linoleic Acid Healthy Cookies
High Linoleic Acid Healthy Cookies (10g grapeseed oil) 1 per day for 2 weeks Phase 1: N=39 adults single arm Phase 2: N=42 adults
干预措施: High Linoleic Acid Healthy Cookies (Other)
High Oleic Acid Healthy Cookies
High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults
干预措施: High Oleic Acid Healthy Cookies (Other)
结局指标
主要结局
Changes in fasting fatty acid levels
时间窗: Baseline through Week 02
Linoleic acid content of fasting blood samples
Changes in cardiolipin
时间窗: Baseline through Week 02
Cardiolipin content in fasting blood samples
Acceptability of Cookies
时间窗: Baseline through Week 02
9-point sensory evaluation of healthy cookies
次要结局
- Correlation of linoleic acid in the blood with body strength(Baseline through Week 02)
- Correlation of linoleic acid in the blood with body movement(Baseline through Week 02)
- Correlation of linoleic acid in blood with body size(Baseline through Week 02)
- Correlation of linoleic acid in blood with body shape(Baseline through Week 02)
- Correlation of linoleic acid in blood with sleep(Baseline through Week 02)
- Correlation of linoleic acid in blood with physical activity(Baseline through Week 02)
- Correlation of fatty acids in blood with diet(Baseline through Week 02)
研究者
Martha Belury
Professor
Ohio State University