Cottonseed Oil for High Cholesterol

Overseen By Jamie Cooper, PhD

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

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications, including those affecting digestion, metabolism, lipid-lowering medications, diabetes medications, steroid/hormone therapies, or current antibiotic cycles. If you are on any of these, you may need to stop taking them to participate.

What data supports the effectiveness of the treatment Cottonseed Oil for high cholesterol?

Research shows that a diet rich in cottonseed oil can lower total cholesterol and LDL (bad cholesterol) levels in both men and women, without affecting HDL (good cholesterol). This suggests that cottonseed oil may be effective in improving cholesterol profiles and reducing cardiovascular disease risk. ^{1 2 3 4 5}

Is cottonseed oil safe for human consumption?

Cottonseed oil is generally considered safe for human consumption when used within established limits for contaminants like gossypol and heavy metals. It has been used safely in cosmetic formulations and did not show toxicity in animal studies. However, it is important to ensure that the oil is free from harmful substances. ^{1 3 5 6 7}

How does the treatment Cottonseed Oil differ from other treatments for high cholesterol?

Cottonseed Oil is unique because it is a dietary oil rich in polyunsaturated fats, which can lower total and LDL cholesterol levels without affecting HDL cholesterol. Unlike some other treatments, it is consumed as part of a diet rather than as a medication, and it has shown promising results in improving cholesterol profiles in a short period. ^{1 2 3 5 8}

What is the purpose of this trial?

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. The specific aims are: * Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. * Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: * Consume provided meal replacement shakes daily for 28-days. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials, * Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.

Research Team

Jamie A Cooper, Ph.D.

Principal Investigator

University of Georgia

Eligibility Criteria

This trial is for individuals with obesity or high cholesterol who are interested in testing the effects of cottonseed oil (CSO) on their health. Participants will use meal replacement shakes and attend regular visits for blood draws and measurements. Those with cardiovascular risk factors may benefit.

Inclusion Criteria

Overweight/obesity defined by body mass index >25 kg/m²

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

My cholesterol levels are high or borderline in two or more categories.

Exclusion Criteria

Fasting blood glucose levels >126 mg/dL

I am taking medications that affect digestion, metabolism, or hormones.

I have a chronic disease like asthma, lung, or kidney disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-intervention

Participants undergo baseline measurements including anthropometrics and fasting blood draw

1 week

1 visit (in-person)

Dietary Intervention

Participants consume daily meal replacement shakes for 28 days and attend weekly visits for fasting blood draws and body measurements

4 weeks

3 weekly visits (in-person), 2 longer testing visits (in-person)

Post-intervention

Participants undergo post-intervention measurements similar to pre-intervention to assess changes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Cottonseed Oil
• Matched PUFA Diet

Trial Overview The study compares the impact of CSO to a matched polyunsaturated fatty acid (PUFA) diet on lipid metabolism and chronic disease markers. It involves daily shakes, weekly check-ins, and two longer visits for detailed assessments over a 28-day period.

Participant Groups

Group I: MATCHED PUFA DIET Experimental Treatment 1 Intervention

Participants are given a daily shake enriched with a mixture of oils with a similar fatty acid profile to CSO and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

Group II: COTTONSEED OIL Experimental Treatment 1 Intervention

Participants are given a daily shake enriched with cottonseed oil and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

Group III: CONTROL Active Control 1 Intervention

Participants are given a daily shake enriched with a mixture of oils that match the fatty acid profile of the average American diet, and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Findings from Research

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]

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]

Cottonseed oil (CS-O) is a valuable source of vitamin E and has a unique fatty acid profile, making it beneficial for antioxidant activities, anti-inflammatory effects, and cardiovascular protection.

CS-O can be extracted using various methods, and despite some loss of tocopherols during processing, it remains a versatile oil with applications in cooking, biofuels, cosmetics, and agriculture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cottonseed oil: A review of extraction techniques, physicochemical, functional, and nutritional properties. Riaz, T., Iqbal, MW., Mahmood, S., et al.[2023]

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]

Cottonseed Oil and its derivatives, including Hydrogenated Cottonseed Oil, are generally safe for use in cosmetics, showing no significant toxicity in animal studies and no irritation in clinical formulations.

While Cottonseed Oil can have some adverse effects, such as increased mammary tumors in certain studies, it also demonstrated protective effects against tumor incidence when compared to sunflower oil, suggesting a complex safety profile that requires careful monitoring of contaminants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Final report on the safety assessment of Hydrogenated Cottonseed Oil, Cottonseed (Gossypium) Oil, Cottonseed Acid, Cottonseed Glyceride, and Hydrogenated Cottonseed Glyceride. [2019]

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]

Dietary cottonseed protein has been shown to effectively lower plasma cholesterol levels in rabbits and rats compared to casein, suggesting it may be beneficial for cholesterol metabolism.

In humans, replacing animal proteins with cottonseed protein may lead to a small decrease in serum cholesterol levels, although more research is needed to confirm this effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cottonseed protein and cholesterol metabolism. Beynen, AC., Liepa, GU.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Consumption of a diet rich in cottonseed oil (CSO) lowers total and LDL cholesterol in normo-cholesterolemic subjects. [2021]

2. United States 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. [2019]

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

The effect of cottonseed oil on lipids/lipoproteins: a systematic review and plasma cholesterol predictive equations estimations. [2023]

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

Cottonseed oil: A review of extraction techniques, physicochemical, functional, and nutritional properties. [2023]

5. United States 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. [2023]

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

Final report on the safety assessment of Hydrogenated Cottonseed Oil, Cottonseed (Gossypium) Oil, Cottonseed Acid, Cottonseed Glyceride, and Hydrogenated Cottonseed Glyceride. [2019]

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

A cottonseed oil-enriched diet improves liver and plasma lipid levels in a male mouse model of fatty liver. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Dietary cottonseed protein and cholesterol metabolism. [2019]