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NCT Number: NCT04677920

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Linoleic Acid Healthy Cookies

Other

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

Primary outcomes

  1. Changes in mitochondria function

    Time frame: Week 0 to Week 2

    Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle

  2. Changes in cardiolipin species

    Time frame: Week 0 to week 2

    Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

  3. 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

  1. Changes in fasting fatty acid levels

    Time frame: Week 0 to week 2

    Linoleic acid content of fasting blood samples

  2. Correlation of fatty acids with mitochondrial function and cardiolipin species

    Time frame: Week 0 and week 2

    Correlation of linoleic acid in blood with mitochondria function and cardiolipin species in peripheral blood mononuclear cells and skeletal muscle

  3. Correlation of cardiolipin with global sleep quality score, Cambridge physical activity index and dietary intake of omega-3 fats

    Time frame: Week 0 and week 2

    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

  4. Correlation of cardiolipin with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength

    Time frame: Week 0 and week 2

    Correlation of cardiolipin in peripheral blood mononuclear cells and skeletal muscle with measurements of body mass index, sagittal diameter, grip strength and gait speed

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: HCES

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 21, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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