Healthy AdultsNCT02841618
The Healthy Cookie Study: Understanding How Healthy Cookies Affect Fat in the Blood,
A study testing High Linoleic Acid Healthy Cookies and High Oleic Acid Healthy Cookies in people with Healthy Adults, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- High Linoleic Acid Healthy Cookies and High Oleic Acid Healthy Cookies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 1 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nonsmokers
Who cannot join
- Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer.
- Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
- Food Allergy or Intolerance \& Bee allergy
- 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
- Use of supplements/oils high in linoleic acid in the past 4 weeks prior to enrolling
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Human Nutrition Laboratory
Columbus, Ohio
About this study
The purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.
Read the detailed description
Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin. It is therefore imperative to develop foods products that allow for Americans to easily increase their intake of linoleic acid. It's also important to understand the mechanism in which linoleic acid exerts these positive health effects, particularly in states of muscle mass and quality loss associated with mitochondria dysfunction.
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims
Aim 1: To determine the extent to which cookies, made with grapeseed oil , increase linoleic acid in plasma, red blood cells (RBCs), and peripheral blood mononuclear cells (PBMCs) fraction of blood after two weeks consumption
Aim 2: To determine the extent to which cookies, made with grapeseed oil, increase cardiolipin and linoleic acid content of cardiolipin in PBMCs after two weeks of consumption
Aim 3: To determine and compare the acceptability of consuming cookies made with grapeseed oil or high oleic safflower oil every day for two weeks
- Conditions
- Healthy Adults
- Being tested
- High Linoleic Acid Healthy Cookies, High Oleic 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 Oleic Acid Healthy CookiesOther
| Study group | Role | What they receive |
|---|---|---|
| High Linoleic Acid Healthy Cookies | Experimental | High Linoleic Acid Healthy Cookies (10g grapeseed oil) 1 per day for 2 weeks Phase 1: N=39 adults single arm Phase 2: N=42 adults Receives: Other: High Linoleic Acid Healthy Cookies |
| High Oleic Acid Healthy Cookies | Placebo comparator | High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults Receives: Other: High Oleic Acid Healthy Cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fasting fatty acid levels
Linoleic acid content of fasting blood samples
Measured: Baseline through Week 02
Changes in cardiolipin
Cardiolipin content in fasting blood samples
Measured: Baseline through Week 02
Acceptability of Cookies
9-point sensory evaluation of healthy cookies
Measured: Baseline through Week 02
Secondary outcomes (7)
Correlation of linoleic acid in the blood with body strength
grip strength measurement
Measured: Baseline through Week 02
Correlation of linoleic acid in the blood with body movement
gait speed measurement
Measured: Baseline through Week 02
Correlation of linoleic acid in blood with body size
Body Mass Index measurement
Measured: Baseline through Week 02
Correlation of linoleic acid in blood with body shape
Abdominal thickness measurement
Measured: Baseline through Week 02
Correlation of linoleic acid in blood with sleep
Sleeping questionnaire
Measured: Baseline through Week 02
Correlation of linoleic acid in blood with physical activity
Physical Activity questionnaire
Measured: Baseline through Week 02
Correlation of fatty acids in blood with diet
omega-3 fat intake questionnaire
Measured: Baseline through Week 02
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two Phases: Phase 1: Single arm, grapeseed oil cookie (N=39 adults) Phase 2: Triple masked, grapeseed or safflower oil cookie (N=84 adults)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
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
- NCT02841618
- Sponsor's protocol ID
- 2015H0209
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2016
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 Study: Understanding How Healthy Cookies Affect Fat in the Blood,
- ClinicalTrials.gov ID
- NCT02841618
- Acronym / sponsor ID
- 2015H0209
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- 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 purpose of this study is to understand how consuming healthy cookies every day for two weeks will affect different types of fat in the blood. Specifically, the overall goal of this study is to find out if the healthy cookies can increase a polyunsaturated fat called linoleic acid in plasma, red blood cells and white blood cells.
Detailed description
Overall, linoleic acid has many health benefits including altering body composition and energy metabolism, possibly through its impact on cardiolipin. It is therefore imperative to develop foods products that allow for Americans to easily increase their intake of linoleic acid. It's also important to understand the mechanism in which linoleic acid exerts these positive health effects, particularly in states of muscle mass and quality loss associated with mitochondria dysfunction.
The investigators plan to test the central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims
Aim 1: To determine the extent to which cookies, made with grapeseed oil , increase linoleic acid in plasma, red blood cells (RBCs), and peripheral blood mononuclear cells (PBMCs) fraction of blood after two weeks consumption
Aim 2: To determine the extent to which cookies, made with grapeseed oil, increase cardiolipin and linoleic acid content of cardiolipin in PBMCs after two weeks of consumption
Aim 3: To determine and compare the acceptability of consuming cookies made with grapeseed oil or high oleic safflower oil every day for two weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two Phases: Phase 1: Single arm, grapeseed oil cookie (N=39 adults) Phase 2: Triple masked, grapeseed or safflower oil cookie (N=84 adults)
| Arm | Type | Receives |
|---|---|---|
| High Linoleic Acid Healthy Cookies | Experimental | Other: High Linoleic Acid Healthy CookiesHigh Linoleic Acid Healthy Cookies (10g grapeseed oil) 1 per day for 2 weeks Phase 1: N=39 adults single arm Phase 2: N=42 adults |
| High Oleic Acid Healthy Cookies | Placebo comparator | Other: High Oleic Acid Healthy CookiesHigh Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nonsmokers
Key exclusion criteria (7 listed)
- Current or previous diagnosis of diabetes, heart (including stroke or heart attack), kidney, liver or circulatory diseases and/or current treatment for cancer.
- Gastrointestinal diseases or disorders (including pancreatic) or gastric bypass surgery
- Food Allergy or Intolerance \& Bee allergy
- 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 Cookies | Other | High Linoleic Acid Healthy Cookies |
| High Oleic Acid Healthy Cookies | Other | High Oleic Acid Healthy Cookies |
Primary outcome
Changes in fasting fatty acid levels
Time frame: Baseline through Week 02
Linoleic acid content of fasting blood samples
Changes in cardiolipin
Time frame: Baseline through Week 02
Cardiolipin content in fasting blood samples
Acceptability of Cookies
Time frame: Baseline through Week 02
9-point sensory evaluation of healthy cookies
7 secondary outcomes
Correlation of linoleic acid in the blood with body strength
Time frame: Baseline through Week 02
Correlation of linoleic acid in the blood with body movement
Time frame: Baseline through Week 02
Correlation of linoleic acid in blood with body size
Time frame: Baseline through Week 02
Correlation of linoleic acid in blood with body shape
Time frame: Baseline through Week 02
Correlation of linoleic acid in blood with sleep
Time frame: Baseline through Week 02
Correlation of linoleic acid in blood with physical activity
Time frame: Baseline through Week 02
Correlation of fatty acids in blood with diet
Time frame: Baseline through Week 02
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 and High Oleic 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 7 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. Some participants in this study may receive a placebo. 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 fasting fatty acid levels (time frame: Baseline through Week 02). 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.