THE HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ohio State University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Changes in cardiolipin species
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Healthy Cookie Group
All participants in the study
Intervention: High Linoleic Acid Healthy Cookies (Other)
Outcomes
Primary Outcomes
Changes in cardiolipin species
Time Frame: Week 0 to week 2
Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Changes in mitochondria function
Time Frame: Week 0 to Week 2
Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle
Correlation of mitochondrial biology in blood and skeletal muscle
Time Frame: Week 0 and week 2
Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Secondary Outcomes
- Changes in fasting fatty acid levels(Week 0 to week 2)
- Correlation of fatty acids with mitochondrial function and cardiolipin species(Week 0 and week 2)
- Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats(Week 0 and week 2)
- Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength(Week 0 and week 2)
Investigators
Martha Belury
Associate Professor
Ohio State University