Clinical trial NCT04677920: The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
Official title: The HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in mitochondria function
timeFrame: Week 0 to Week 2
measure: Changes in cardiolipin species
timeFrame: Week 0 to week 2
measure: Correlation of mitochondrial biology in blood and skeletal muscle
timeFrame: Week 0 and week 2
Secondary outcomes:
measure: Changes in fasting fatty acid levels
timeFrame: Week 0 to week 2
measure: Correlation of fatty acids with mitochondrial function and cardiolipin species
timeFrame: Week 0 and week 2
measure: Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats
timeFrame: Week 0 and week 2
measure: Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength
timeFrame: Week 0 and week 2
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: