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, others

Disqualifiers: Familial hypercholesterolemia, Pregnancy, Chronic diseases, others

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether consuming cottonseed oil three times a week can improve cholesterol levels and reduce cardiovascular disease risks. Participants will consume meal shakes and snacks with varying amounts of cottonseed oil to assess its effects on blood lipids and other health markers. The trial seeks individuals with high cholesterol or those who are overweight. Participants should not have significant health issues or planned lifestyle changes that could interfere with the study. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially enhance personal health outcomes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, especially those affecting digestion, absorption, or metabolism, as well as lipid-lowering medications, diabetes medications, and steroid/hormone therapies.

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

Research has shown that adding cottonseed oil (CSO) to the diet can improve cholesterol levels in healthy adults. In one study, participants who used CSO for eight weeks experienced significant improvements in their blood fats. Another study found that a high-fat diet with CSO improved cholesterol and triglycerides more than a diet with olive oil in healthy men over five days.

These results suggest that CSO is generally well-tolerated. However, some studies indicate a slight increase in total and LDL cholesterol levels with CSO. Overall, the evidence supports the safety of including CSO as part of a balanced diet. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about intermittent cottonseed oil consumption for high cholesterol because it introduces a novel dietary approach rather than relying on traditional medications like statins or cholesterol absorption inhibitors. Unlike standard treatments that often come in pill form and may have side effects, cottonseed oil is a natural food product that can be integrated into one's diet. This treatment focuses on maintaining caloric balance while potentially providing cardiovascular benefits, making it an appealing alternative for those seeking a more natural and lifestyle-focused solution to managing cholesterol levels.

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

Research has shown that cottonseed oil (CSO) can improve blood fats, such as cholesterol and triglycerides. In this trial, participants will join different treatment arms to assess CSO's effects. One study found that diets with 20% and 30% CSO improved fasting blood fats in adults at risk for heart disease. Another study showed that diets high in CSO significantly lowered total cholesterol and triglycerides. These findings suggest that adding CSO to the diet might improve cholesterol levels and reduce heart disease risk factors. ^{1 5 6 7 8}

Who Is on the Research Team?

Jamie Cooper, PhD

Principal Investigator

University of Georgia

Are You a Good Fit for This Trial?

This trial is for individuals with high cholesterol, obesity, or diabetic dyslipidemia interested in improving their nutrition. Participants should be willing to consume meal replacement shakes and snacks three times a week and attend bi-weekly visits for blood draws and measurements. They must also be available for two longer testing visits.

Inclusion Criteria

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

Elevated cholesterol profiles defined as 'Borderline High' and/or 'at risk' in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or 'High' in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL)

Exclusion Criteria

Fasting blood glucose levels greater than 126 mg/dL

I have been on hormone replacement therapy for less than 2 years.

Pregnant women

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 including anthropometrics and fasting blood draws

1 day

1 visit (in-person)

Dietary Intervention

Participants consume meal replacement shakes and snacks 3 times per week for 56 days, with bi-weekly visits for fasting blood draws and body measurements

8 weeks

3 bi-weekly visits (in-person)

Post-intervention

Participants undergo final measurements including anthropometrics and fasting blood draws

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in health outcomes and markers of chronic disease risk

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Cottonseed Oil Consumption

Trial Overview The study tests the effects of intermittent cottonseed oil (CSO) consumption on fasting/postprandial lipids and chronic disease markers. It compares two doses of CSO (30g and 20g), taken three times weekly, against a control group with no oil over 56 days.

How Is the Trial Designed?

Group I: CSO-30 Experimental Treatment 1 Intervention

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

Group II: CSO-20 Experimental Treatment 1 Intervention

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

Group III: Control Placebo Group 1 Intervention

Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

Cotton Incorporated

Collaborator

Trials

3

Recruited

240+

Citations

1. jn.nutrition.org jn.nutrition.org/article/S0022-3166(25)00702-3/fulltext

Dose Response Effects of Cottonseed Oil on Blood Lipid ... Enriching diets with 10%, 20%, and 30% CSO improved fasting blood lipids in CVD at-risk adults with the best results in the 20% and 30% doses.

2. 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).

3. journals.physiology.org journals.physiology.org/doi/full/10.1152/ajpregu.00052.2022

A cottonseed oil-enriched diet improves liver and plasma ... The CSO group had lower plasma total cholesterol (−56 ± 6%, P < 0.01), free cholesterol (−53 ± 7%, P < 0.01), triglycerides (−61 ± 14%, P < 0.01), and LDL (−42 ...

4. liebertpub.com liebertpub.com/doi/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 ...

5. mdpi.com mdpi.com/2072-6643/4/7/602

Consumption of a Diet Rich in Cottonseed Oil (CSO) ... Animal data indicates that dietary cottonseed oil (CSO) may lower cholesterol; however, the effects of a CSO-rich diet have not been evaluated in humans.

6. nutrition.org nutrition.org/cottonseed-oil-a-possible-nutritional-therapeutic-for-adults-with-hypercholesterolemia/

Cottonseed oil: A possible nutritional therapeutic for adults ... Study results showed that consumption of a diet enriched with cottonseed oil for 8 weeks resulted in significant improvements in blood lipids ...

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

The effect of cottonseed oil on lipids/lipoproteins: a systematic ... Compared with the healthy eating pattern, incorporating 27 g of CSO was predicted to increase TC and LDL-C levels by 2.4 mg/dL. Conclusion.

8. usda.gov usda.gov/about-usda/news/blog/healthier-frying-withcottonseed-oil

Healthier Frying with…Cottonseed Oil Oleic acid is commonly used for preventing heart disease and reducing cholesterol. According to Jay Shockey, plant geneticist with SRRC's ...