Healthy Cookies for Blood Fat Levels in Healthy Adults

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Diabetes, Heart disease, Cancer, others

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

123 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if your medications would conflict with eating the healthy cookies.

What evidence supports the effectiveness of the treatment High Linoleic Acid Healthy Cookies and High Oleic Acid Healthy Cookies for managing blood fat levels in healthy adults?

Research suggests that linoleic acid, a type of polyunsaturated fatty acid found in many foods, can help reduce the risk of cardiovascular disease by influencing blood fat levels. However, there is no direct evidence from the provided studies specifically linking these cookies to improved blood fat levels in healthy adults. ^{1 2 3 4 5}

Is it safe for humans to consume cookies with high linoleic or oleic acid?

Research on similar substances like alpha-linolenic acid (ALA) suggests it is safe for humans, as studies found no adverse effects in blood tests or urinalysis when consumed in controlled amounts. However, specific safety data for high linoleic or oleic acid cookies is not directly available. ^{6 7 8 9 10}

How do Healthy Cookies for Blood Fat Levels differ from other treatments?

The Healthy Cookies for Blood Fat Levels are unique because they use high linoleic and high oleic acid, which are types of fats found in certain oils, to potentially influence blood fat levels in healthy adults. Unlike traditional treatments that might focus on medications or supplements, this approach uses specially formulated cookies as a dietary intervention. ^{1 6 7 11 12}

Eligibility Criteria

This trial is for healthy adults who don't smoke and have no food or bee allergies, dietary restrictions that conflict with cookie ingredients, gastrointestinal diseases, or a history of major illnesses like diabetes, heart disease, kidney or liver issues. Pregnant individuals and those on certain medications are also excluded.

Inclusion Criteria

You do not smoke.

Exclusion Criteria

I have or had diabetes, heart, kidney, liver, circulatory diseases, or am being treated for cancer.

You are pregnant.

You have a food allergy or intolerance, and/or an allergy to bees.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume healthy cookies daily for two weeks to assess changes in blood fatty acids

2 weeks

Daily consumption, 1 visit (in-person) at the end of the phase

Follow-up

Participants are monitored for changes in blood fatty acids and other health metrics after treatment

4 weeks

Treatment Details

Interventions

• High Linoleic Acid Healthy Cookies
• High Oleic Acid Healthy Cookies

Trial Overview The study aims to see if eating 'healthy cookies' rich in linoleic acid or oleic acid every day for two weeks can increase levels of these fats in the blood. It's testing whether these cookies could be beneficial for health by affecting blood fat content.

Participant Groups

Group I: High Linoleic Acid Healthy Cookies Experimental Treatment 1 Intervention

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

Group II: High Oleic Acid Healthy Cookies Placebo Group 1 Intervention

High Oleic Acid Healthy Cookies (10g safflower oil) 1 per day for 2 weeks Matched for Phase 2: N=42 adults

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

References

1. 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]

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

[Changes in the fatty acid composition of erythrocyte and platelet membranes after diet therapy in patients with hyperlipoproteinemia type II]. [2006]

3. Scotland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Polyunsaturated fatty acids and coronary heart disease. [2019]

5. 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]

6. 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]

7. Japan pubmed.ncbi.nlm.nih.gov

Antihypertensive effect and safety of dietary alpha-linolenic acid in subjects with high-normal blood pressure and mild hypertension. [2019]

8. 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]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Fat induced hypertension in rabbits: the effects of dietary linoleic and linolenic acid. [2019]

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

Is there a beneficial effect of gamma-linolenic acid supplementation on body fat in postmenopausal hypertensive women? A prospective randomized double-blind placebo-controlled trial. [2021]

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

[Polyunsaturated fatty acids in the diagnosis of cardiovascular diseases]. [2006]

12. England pubmed.ncbi.nlm.nih.gov

Effect of a monounsaturated diet vs. a polyunsaturated fatty acid-enriched diet on blood pressure in normotensive women and men. [2019]