Healthy AdultsHCESNCT04677920
The Healthy Cookie Energy Study: Understanding How Healthy Cookies Affect Mitochondrial Biology
A study testing High Linoleic Acid Healthy Cookies in people with Healthy Adults, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- High Linoleic Acid Healthy Cookies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2020to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Adults
- Being tested
- High Linoleic Acid Healthy Cookies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Linoleic Acid Healthy CookiesOther
High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy Cookie Group | Experimental | All participants in the study Receives: Other: High Linoleic Acid Healthy Cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mitochondria function
Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle
Measured: Week 0 to Week 2
Changes in cardiolipin species
Cardiolipin species in peripheral blood mononuclear cells and skeletal muscle
Measured: 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
Measured: Week 0 and week 2
Secondary outcomes (4)
Changes in fasting fatty acid levels
Linoleic acid content of fasting blood samples
Measured: 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
Measured: 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
Measured: 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
Measured: Week 0 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start7 Sep 2020
- Primary completion1 Dec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Belury, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677920
- Sponsor's protocol ID
- 2020H0352
- Acronym
- HCES
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE HEALTHY COOKIE ENERGY STUDY: Understanding How Healthy Cookies Affect Mitochondrial Biology
- ClinicalTrials.gov ID
- NCT04677920
- Acronym / sponsor ID
- HCES / 2020H0352
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Cookie Group | Experimental | Other: High Linoleic Acid Healthy CookiesAll participants in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nonsmoker
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Linoleic Acid Healthy CookiesHigh Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks | Other | Healthy Cookie Group |
Primary outcome
Changes in mitochondria function
Time frame: Week 0 to Week 2
Mitochondria function measured in peripheral blood mononuclear cells and skeletal muscle
Changes in cardiolipin species
Time frame: Week 0 to week 2
Cardiolipin species 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
4 secondary outcomes
Changes in fasting fatty acid levels
Time frame: Week 0 to week 2
Correlation of fatty acids with mitochondrial function and cardiolipin species
Time frame: Week 0 and week 2
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 with body mass index, sagittal diameter (abdominal thickness), walking speed and grip strength
Time frame: Week 0 and week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Linoleic Acid Healthy Cookies in people with Healthy Adults, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mitochondria function (time frame: Week 0 to Week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.