The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,
- Conditions
- Healthy Adults
- Interventions
- Other: High Oleic Acid Healthy CookiesOther: High Linoleic Acid Healthy Cookies
- Registration Number
- NCT02841618
- Lead Sponsor
- Ohio State University
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 123
- Nonsmokers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Oleic Acid Healthy Cookies 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 High Linoleic Acid Healthy Cookies 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
- Primary Outcome Measures
Name Time Method Changes in fasting fatty acid levels Baseline through Week 02 Linoleic acid content of fasting blood samples
Changes in cardiolipin Baseline through Week 02 Cardiolipin content in fasting blood samples
Acceptability of Cookies Baseline through Week 02 9-point sensory evaluation of healthy cookies
- Secondary Outcome Measures
Name Time Method Correlation of linoleic acid in the blood with body strength Baseline through Week 02 grip strength measurement
Correlation of linoleic acid in the blood with body movement Baseline through Week 02 gait speed measurement
Correlation of linoleic acid in blood with physical activity Baseline through Week 02 Physical Activity questionnaire
Correlation of linoleic acid in blood with body size Baseline through Week 02 Body Mass Index measurement
Correlation of linoleic acid in blood with body shape Baseline through Week 02 Abdominal thickness measurement
Correlation of linoleic acid in blood with sleep Baseline through Week 02 Sleeping questionnaire
Correlation of fatty acids in blood with diet Baseline through Week 02 omega-3 fat intake questionnaire
Trial Locations
- Locations (1)
The Ohio State University Human Nutrition Laboratory
🇺🇸Columbus, Ohio, United States
The Ohio State University Human Nutrition Laboratory🇺🇸Columbus, Ohio, United States