The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,

Study Overview
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Brief Summary
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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
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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

Conditions
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Healthy Adults

Intervention / Treatment
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* Other: High Linoleic Acid Healthy Cookies
* Other: High Oleic Acid Healthy Cookies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsmokers Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two Phases: Phase 1: Single arm, grapeseed oil cookie (N=39 adults) Phase 2: Triple masked, grapeseed or safflower oil cookie (N=84 adults)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Linoleic Acid Healthy Cookies<br>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 | Other: High Linoleic Acid Healthy Cookies<br> <br> |
| Placebo Comparator: High Oleic Acid Healthy Cookies<br>High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults | Other: High Oleic Acid Healthy Cookies<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting fatty acid levels | Linoleic acid content of fasting blood samples | Baseline through Week 02 | 
| Changes in cardiolipin | Cardiolipin content in fasting blood samples | Baseline through Week 02 | 
| Acceptability of Cookies | 9-point sensory evaluation of healthy cookies | Baseline through Week 02 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of linoleic acid in the blood with body strength | grip strength measurement | Baseline through Week 02 | 
| Correlation of linoleic acid in the blood with body movement | gait speed measurement | Baseline through Week 02 | 
| Correlation of linoleic acid in blood with body size | Body Mass Index measurement | Baseline through Week 02 | 
| Correlation of linoleic acid in blood with body shape | Abdominal thickness measurement | Baseline through Week 02 | 
| Correlation of linoleic acid in blood with sleep | Sleeping questionnaire | Baseline through Week 02 | 
| Correlation of linoleic acid in blood with physical activity | Physical Activity questionnaire | Baseline through Week 02 | 
| Correlation of fatty acids in blood with diet | omega-3 fat intake questionnaire | Baseline through Week 02 |