Cottonseed Oil for Dyslipidemia

Overseen By Jamie A Cooper, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Must not be taking: Thyroid meds, Lipid-lowering, Diabetes meds, Steroid/hormone

Disqualifiers: Familial hypercholesterolemia, Pregnancy, Chronic diseases, Cancer, others

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

Compensation: Varies

Number of Visits: 6

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different amounts of cottonseed oil (CSO) in the diet might affect cholesterol levels and other health markers related to heart disease. Participants will consume foods enriched with varying levels of CSO to determine its effects on cholesterol, blood sugar, and inflammation. This trial suits adults who have struggled with high cholesterol or are overweight and at risk for heart disease. Participants will replace some regular meals with study foods and attend visits for blood tests and measurements. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on heart health.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes people using medications that affect digestion, metabolism, lipid levels, diabetes, and certain hormone therapies.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cottonseed oil (CSO) can improve blood fat levels, which are important for heart health. Studies have found that CSO is high in beneficial fats called omega-6 polyunsaturated fatty acids, which can enhance cholesterol levels.

Regarding safety, previous studies have incorporated CSO into diets without major issues. Most participants tolerated it well and did not report significant side effects. So far, these studies have not reported serious negative effects from using CSO.

Overall, research suggests that CSO is safe for consumption. It has been tested in various groups, including both young and older adults. For those considering joining this trial, current evidence indicates that CSO is safe and may improve cholesterol and heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cottonseed oil (CSO) for treating dyslipidemia because it offers a natural alternative to traditional medications like statins, which can sometimes cause side effects. Unlike other treatments that directly lower cholesterol through chemical means, CSO is integrated into the diet through enriched foods, making it a more lifestyle-friendly option. The study explores different levels of CSO (LOW, MID, HIGH), which could provide insights into optimizing its effectiveness. Additionally, CSO's potential to maintain caloric balance while altering lipid profiles is another exciting feature that differentiates it from existing options.

What evidence suggests that this trial's treatments could be effective for dyslipidemia?

This trial will evaluate the effects of different levels of cottonseed oil (CSO) on cholesterol levels. Participants will be assigned to one of several treatment arms: CSO HIGH, CSO MID, and CSO LOW, where they will consume foods enriched with varying amounts of cottonseed oil. Another group will receive a CONTROL oil mix.

Studies have shown that adding cottonseed oil to the diet can improve cholesterol levels. In one study, participants who ate a diet rich in CSO for 56 days had lower total cholesterol and lower LDL cholesterol, often called "bad" cholesterol. Other research found that a high-fat diet with CSO lowered cholesterol and triglycerides (fats in the blood) more effectively than olive oil in healthy men. Additionally, a trial with healthy adults showed that after just one week of consuming CSO, both total cholesterol and LDL levels dropped significantly. These findings suggest that CSO might help improve heart health by lowering bad cholesterol levels. ^{1 2 3 6 7}

Who Is on the Research Team?

Jamie A Cooper, Ph.D.

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

Adults aged 25-75 with an increased risk for cardiovascular disease, defined by either high cholesterol levels or being overweight/obese (BMI of 25 kg/m2 or higher), can join this trial. Exclusions include those with digestion issues, heavy alcohol use, metabolic diseases, excessive exercise habits, recent weight fluctuations, and certain medical conditions like uncontrolled blood pressure.

Inclusion Criteria

My BMI indicates I am overweight or obese.

I am between 25-75 years old and at risk for heart disease due to high cholesterol or being overweight.

You are considered overweight or obese based on your body mass index (BMI).

Exclusion Criteria

I have very high cholesterol and a family history of early heart attacks.

You use tobacco or nicotine products.

You have a body mass index (BMI) less than 18.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-intervention

Participants undergo baseline measurements and a high-saturated-fat meal challenge

1 day

1 visit (in-person)

Dietary Intervention

Participants consume provided breakfast shakes and snacks daily for 28 days, with weekly visits for fasting blood draws and body measurements

4 weeks

3 weekly short visits (in-person)

Post-intervention

Participants repeat baseline measurements and meal challenge to assess changes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CONTROL
• CSO HIGH
• CSO LOW
• CSO MID

Trial Overview

The study is testing the effects of different doses of cottonseed oil (CSO) on cholesterol profiles and other health markers related to heart disease risk. Participants will consume CSO at low, medium or high amounts or a control oil blend in their diet for 28 days while undergoing regular health checks.

How Is the Trial Designed?

Group I: CSO MID Experimental Treatment 1 Intervention

Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.

Group II: CSO LOW Experimental Treatment 1 Intervention

Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.

Group III: CSO HIGH Experimental Treatment 1 Intervention

Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.

Group IV: CONTROL Active Control 1 Intervention

Participants are given foods enriched with a mixture of oils and instructed on how to substitute study foods into their diet to maintain caloric balance.

CSO HIGH is already approved in United States, European Union for the following indications:

Approved in United States as Cottonseed Oil for:

• Cardiovascular disease prevention
• Cholesterol management

Approved in European Union as Cottonseed Oil for:

• Cardiovascular disease prevention
• Cholesterol management

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Cotton Incorporated

Collaborator

Trials

3

Recruited

240+

Published Research Related to This Trial

In a study using mice on a high-fat diet, those fed cottonseed oil (CSO) showed significantly lower levels of total cholesterol, free cholesterol, triglycerides, and LDL compared to the high-fat control group, indicating CSO's potential to improve lipid profiles in fatty liver disease.

When both CSO and olive oil (OO) diets were reduced in calories, both groups lost weight, but CSO was more effective in reducing liver and plasma lipids, suggesting that CSO may be a better dietary option for managing lipid levels in obesity-related fatty liver conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cottonseed oil-enriched diet improves liver and plasma lipid levels in a male mouse model of fatty liver. Son, Y., Shockey, J., Dowd, MK., et al.[2023]

A 5-day high-fat diet rich in cottonseed oil (CSO) significantly improved lipid profiles in normal-weight men, lowering total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides, while increasing high-density lipoprotein (HDL) cholesterol.

In contrast, a diet rich in olive oil (OO) did not result in any significant changes in blood lipid levels, highlighting the potential cardiovascular benefits of CSO over OO in a short-term dietary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 5-day high-fat diet rich in cottonseed oil improves cholesterol profiles and triglycerides compared to olive oil in healthy men. Polley, KR., Oswell, NJ., Pegg, RB., et al.[2019]

Cottonseed oil (CSO) may improve lipid profiles by significantly lowering fasting low-density lipoprotein cholesterol (LDL-C) and triglycerides compared to olive oil, based on a systematic review of 2 trials with 58 participants.

Incorporating CSO into a healthy dietary pattern is predicted to lower total cholesterol and LDL-C levels without significantly affecting high-density lipoprotein cholesterol, suggesting it can be a beneficial addition to diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of cottonseed oil on lipids/lipoproteins: a systematic review and plasma cholesterol predictive equations estimations. Hart, TL., Petersen, KS., Kris-Etherton, PM.[2023]

In a study involving 38 healthy adults consuming a cottonseed oil-rich diet for one week, total cholesterol and LDL levels were significantly reduced, indicating potential cholesterol-lowering effects of dietary cottonseed oil.

The reduction in total cholesterol was particularly notable in female participants, while levels of HDL and triglycerides remained unchanged, suggesting that cottonseed oil may be a safe dietary option for lowering cholesterol without negatively impacting beneficial HDL levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of a diet rich in cottonseed oil (CSO) lowers total and LDL cholesterol in normo-cholesterolemic subjects. Davis, KE., Prasad, C., Imrhan, V.[2021]

In a study comparing cottonseed oil (CSO) and corn oil (CO) in male rats, CSO led to lower levels of beneficial fatty acids like oleic acid and alpha-linolenic acid in serum, adipose tissue, and liver, suggesting it may not support optimal lipid status as effectively as CO.

The research indicates that while CSO affects the concentrations of saturated and monounsaturated fatty acids, it does not impact n-6 polyunsaturated fatty acids, highlighting the importance of oil choice in dietary fat composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fatty acid composition of serum, adipose tissue, and liver in rats fed diets containing corn oil or cottonseed oil. Radcliffe, JD., Czajka-Narins, DM., Imrhan, V.[2019]

An 8-week diet intervention with either cottonseed oil (CSO) or olive oil (OO) in 42 adults with untreated hypercholesterolemia showed no significant differences in inflammatory and coagulation markers, suggesting that both types of dietary fat do not promote inflammation.

This study provides further evidence that n-6 polyunsaturated fats, like those in CSO, may not be pro-inflammatory compared to monounsaturated fats, even in individuals at higher risk for cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No Observed Difference in Inflammatory and Coagulation Markers Following Diets Rich in n-6 Polyunsaturated Fat vs Monounsaturated Fat in Adults With Untreated Hypercholesterolemia: A Randomized Trial. Prater, MC., Scheurell, AR., Paton, CM., et al.[2023]

Total replacement of corn oil with cottonseed oil in the diets of growing male rats significantly lowered total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) levels, indicating a potential benefit for cholesterol management.

Partial replacement of corn oil with cottonseed oil (50% mixture) did not affect cholesterol status, suggesting that only complete substitution yields significant changes in cholesterol levels, possibly due to components in cottonseed oil's nonsaponifiable fraction rather than its fatty acid composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum and liver lipids in rats fed diets containing corn oil, cottonseed oil, or a mixture of corn and cottonseed oils. Radcliffe, JD., King, CC., Czajka-Narins, DM., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9449680/

Blood Lipid Responses to Diets Enriched with Cottonseed ...

Previous studies have shown that CSO-rich diets can improve cholesterol profiles in healthy, young adults (11, 12). In addition to a high PUFA content, CSO ...

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liebertpub.com

liebertpub.com/doi/full/10.1089/jmf.2024.0114

Is Cottonseed Oil the Next Healthy Oil?

A 5-day high-fat diet rich in cottonseed oil improves cholesterol profiles and triglycerides compared to olive oil in healthy men. Nutr Res 2018 ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37695308/

The effect of cottonseed oil on lipids/lipoproteins

In a 56-day trial, CSO lowered total cholesterol (TC; ≈ -14.8 mg/dL), LDL-C (≈ -14.0 mg/dL), and non-high-density lipoprotein cholesterol (≈ - ...

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trialx.com

trialx.com/clinical-trials/listings/280087/cottonseed-oil-dose-response/

Cottonseed Oil Dose Response - Overweight and Obesity

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and ...

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withpower.com

withpower.com/trial/phase-overweight-2023-44450

Cottonseed Oil for Dyslipidemia

In a study involving 38 healthy adults consuming a cottonseed oil-rich diet for one week, total cholesterol and LDL levels were significantly reduced, ...

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echemi.com

echemi.com/sds/fatty-acids-cottonseed-oil-pd180521116136.html

Fatty acids, cottonseed-oil Safety Data Sheets

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable ...

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academic.oup.com

academic.oup.com/nutritionreviews/article/82/8/1079/7268824

The effect of cottonseed oil on lipids/lipoproteins: a systematic ...

Cottonseed oil (CSO) is higher in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFAs) than many liquid plant oils.