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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04677920
Acronym
HCES
Enrollment
24
Registered
2020-12-21
Start date
2020-09-07
Completion date
2026-12-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

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

Interventions

High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * Diabetes

Design outcomes

Primary

MeasureTime frameDescription
Changes in mitochondria functionWeek 0 to Week 2Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle
Changes in cardiolipin speciesWeek 0 to week 2Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Correlation of mitochondrial biology in blood and skeletal muscleWeek 0 and week 2Correlation of mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

Secondary

MeasureTime frameDescription
Changes in fasting fatty acid levelsWeek 0 to week 2Linoleic acid content of fasting blood samples
Correlation of fatty acids with mitochondrial function and cardiolipin speciesWeek 0 and week 2Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fatsWeek 0 and week 2Correlation 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
Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strengthWeek 0 and week 2Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026