High Linoleic Acid Healthy Cookies for Healthy Adults

(HCES Trial)

Overseen By Martha Belury, Ph.D., RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Blood thinners

Disqualifiers: Gastrointestinal diseases, Food allergy, Pregnancy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you do not take anticoagulant, antiplatelet, or other blood thinner medications. If your current medications would make eating the healthy cookies unsafe, you may need to stop them.

What data supports the effectiveness of the treatment High Linoleic Acid Healthy Cookies for healthy adults?

Research suggests that linoleic acid, a type of fat found in many foods, does not significantly increase inflammation in healthy people, which is a positive sign for its safety. Additionally, omega-3 fatty acids, which are related to linoleic acid, have been shown to benefit heart health, suggesting that similar fatty acids might also have health benefits. ^{1 2 3 4 5}

Is it safe to consume high linoleic acid cookies?

The research does not provide specific safety data for high linoleic acid cookies, but it does mention that linoleic acid, an omega-6 fatty acid, was not associated with high blood pressure in a study on dietary fats. ^{6 7 8 9 10}

How do High Linoleic Acid Healthy Cookies differ from other treatments for health maintenance?

High Linoleic Acid Healthy Cookies are unique because they incorporate linoleic acid, a common polyunsaturated fatty acid found in many foods, into a convenient snack form. Unlike traditional dietary sources, these cookies offer a novel way to increase linoleic acid intake, which is a key component in maintaining healthy cell membranes and potentially influencing inflammation and cardiovascular health. ^{1 9 11 12 13}

Eligibility Criteria

This trial is for healthy adults who don't smoke and aren't on any medications that clash with the cookies' ingredients. People with gastrointestinal issues, those who are pregnant, have food allergies or intolerances, take blood thinners, or have diabetes can't participate.

Inclusion Criteria

I do not smoke.

Exclusion Criteria

I don't have dietary restrictions that prevent me from eating certain ingredients in healthy cookies.

I have a food allergy or intolerance.

I am not on medications that react badly with certain foods.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants consume 1 healthy cookie rich in linoleic acid each day

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• High Linoleic Acid Healthy Cookies

Trial Overview The study is testing if eating one 'healthy cookie' rich in linoleic acid daily for two weeks can boost mitochondrial function in white blood cells and muscle tissue. It's a short-term intervention to see if these cookies could be beneficial.

Participant Groups

Group I: Healthy Cookie Group Experimental Treatment 1 Intervention

All participants in the study

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

Replacing traditional soybean and canola oils with high-oleic varieties can lead to increased intake of monounsaturated fatty acids (MUFAs) while decreasing saturated fatty acids (SFAs) and polyunsaturated fatty acids (PUFAs), including essential fatty acids (EFAs) like α-linolenic acid (ALA) and linoleic acid (LA).

Modeling scenarios suggest that replacing 25-50% of traditional oils with high-oleic oils may put certain adult age and sex groups at risk of not meeting the Adequate Intake levels for LA and ALA, highlighting a potential nutritional concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeled replacement of traditional soybean and canola oil with high-oleic varieties increases monounsaturated fatty acid and reduces both saturated fatty acid and polyunsaturated fatty acid intake in the US adult population. Raatz, SK., Conrad, Z., Jahns, L., et al.[2023]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

The health implications of changing linoleic acid intakes. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of dietary linoleic acid on markers of inflammation in healthy persons: a systematic review of randomized controlled trials. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Buglossoides Arvensis Oil Increases Circulating n-3 Polyunsaturated Fatty Acids in a Dose-Dependent Manner and Enhances Lipopolysaccharide-Stimulated Whole Blood Interleukin-10-A Randomized Placebo-Controlled Trial. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Extending the cardiovascular benefits of omega-3 Fatty acids. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids and lipoprotein associated phospholipase A(2) in healthy older adult males and females. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Effect of shortening replacement with flaxseed oil on physical, sensory, fatty acid and storage characteristics of cookies. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Modeled replacement of traditional soybean and canola oil with high-oleic varieties increases monounsaturated fatty acid and reduces both saturated fatty acid and polyunsaturated fatty acid intake in the US adult population. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Labeling of trans fatty acid content in food, regulations and limits-the FDA view. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary linolenic acid is associated with a lower prevalence of hypertension in the NHLBI Family Heart Study. [2022]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of the storage-associated changes in the fatty acid profile of oat-based gluten-free cookies prepared with different fats. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Dietary intakes and food sources of n-6 and n-3 PUFA in French adult men and women. [2019]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of antiatherosclerotic diet, containing polyunsaturated fatty acids of the omega-3 family from flax oil, on fatty acid composition of cell membranes of patients with ischemic heart disease. Hypertensive disease and hyperlipoproteinemia]. [2006]

13. United States pubmed.ncbi.nlm.nih.gov

Distribution of omega-3 fatty acids in tissues of rabbits fed a flaxseed-supplemented diet. [2013]