The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology

Study Overview
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Brief Summary
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The proposed research is an intervention and feasibility pilot trial designed to determine if short-term consumption of healthy cookies made with an oil rich in linoleic acid can influence mitochondria biology in white blood cells and muscle. The hypothesis of the study is that consuming 1 healthy cookie rich in linoleic acid each day for two weeks will improve mitochondrial biology in white blood cells and muscle.

Detailed Description
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Linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin and mitochondria. The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following four specific aims Aim 1) To assess muscle biopsy yield with a micro biopsy needle Aim 2) To determine the amount of peripheral blood mononuclear cells (PBMC) and muscle needed to measure mitochondria function Aim 3) To assess the feasibility of measuring mitochondria function on fresh PBMC and muscle samples Aim 4) To determine the effect of short-term healthy cookies made with linoleic acid rich oil on measures of mitochondrial function in white blood cells and muscle as well as their relationship to lipid composition of the blood, markers of metabolic health and markers of mitochondria biogenesis

Official Title
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THE HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology

Conditions
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Healthy Adults

Intervention / Treatment
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* Other: High Linoleic Acid Healthy Cookies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsmoker Exclusion Criteria: Allergy/intolerance to lidocaine 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 Pregnancy Use of anticoagulant, antiplatelet, or other blood thinner medications Diabetes

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Cookie Group<br>All participants in the study | Other: High Linoleic Acid Healthy Cookies<br>* High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mitochondria function | Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle | Week 0 to Week 2 | 
| Changes in cardiolipin species | Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle | Week 0 to week 2 | 
| Correlation of mitochondrial biology in blood and skeletal muscle | Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle | Week 0 and week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fasting fatty acid levels | Linoleic acid content of fasting blood samples | Week 0 to week 2 | 
| Correlation of fatty acids with mitochondrial function and cardiolipin species | Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle | Week 0 and week 2 | 
| Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats | Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of sleep quality using the Pittsburgh Sleep Quality Index, physical activity using the Epic Physical activity short questionnaire and dietary omega-3 intake using the Omega-3 Checklist | Week 0 and week 2 | 
| Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength | Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed | Week 0 and week 2 |