Healthy Diets With Plant Oils for Heart Health

Overseen By Stacey Meily

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Antihypertensives, Statins, Antidiabetics, others

Disqualifiers: Diabetes, Liver disease, Cardiovascular event, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different plant oils in a healthy diet impact heart and metabolic health. Participants will follow a diet including either cottonseed oil or other plant oils, and researchers will compare the effects. The goal is to determine which type of oil best improves health markers related to the heart and metabolism. Individuals with slightly elevated cholesterol levels and a relatively stable weight might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to healthier dietary recommendations.

Will I have to stop taking my current medications?

If you are taking anti-hypertensive, lipid-lowering, or glucose-lowering drugs, you will need to stop them to participate in this trial. Also, if you take supplements that affect the study's outcomes, you must be willing to stop them during the study.

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

Research shows that cottonseed oil (CSO) is generally safe for consumption. Studies have found that diets high in CSO can improve cholesterol levels without causing weight gain, indicating that CSO is well-tolerated by healthy adults.

Research highlights that unsaturated fats from plant oils with similar fatty acids are part of a healthy diet. They are considered safe and support heart health.

Additionally, studies confirm that replacing saturated fats with polyunsaturated fats (PUFA) is beneficial. It improves blood fat levels and reduces the risk of heart disease. This suggests that a diet with a balanced ratio of these fats is also well-tolerated.

In short, these plant oils have a strong record of safety and heart health benefits based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they focus on using plant oils to boost heart health, offering a natural alternative to typical heart-healthy diets. Unlike other treatments that often rely on medications or supplements, these approaches incorporate cottonseed oil and carefully selected plant oil blends directly into a healthy diet. The use of cottonseed oil and plant oils with matched fatty acid profiles or PUFA:SFA ratios could provide a unique way to manage heart health by leveraging the natural properties of these oils. This approach aims to maintain heart health through dietary changes rather than pharmacological interventions, which could appeal to those seeking more holistic or lifestyle-based solutions.

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

Research shows that cottonseed oil (CSO), which participants in this trial may receive as part of the Healthy Diet + Cottonseed Oil (CSOD) arm, can help improve cholesterol levels. One study found that healthy adults who consumed a diet high in CSO experienced significant drops in total cholesterol and LDL, often called "bad cholesterol." Similar heart health benefits have been observed when people replace saturated fats with plant oils. This trial will also test a Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD) arm and a Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD) arm. Studies indicate that swapping saturated fats for polyunsaturated fats (PUFAs) may lower cholesterol and reduce the risk of heart disease. These findings suggest that including these plant oils in the diet could benefit heart health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with a BMI of 25-40, stable weight in the last 6 months, fasting blood sugar under 126 mg/dL, triglycerides below 350 mg/dL, LDL cholesterol between 100 and ≤190 mg/dL, and blood pressure under 140/90 mmHg. It's not for those outside these ranges.

Inclusion Criteria

LDL-C ≥100 mg/dL and ≤190 mg/dL

Blood pressure <140/90 mmHg

Fasting blood glucose <126 mg/dL

Exclusion Criteria

Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period

Lactation within prior 6 months

Follows a vegetarian or vegan diet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a healthy diet containing different plant oils, including cottonseed oil, for 4 weeks in a randomized crossover design

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Dietary Pattern with Cottonseed Oil
• Healthy Dietary Pattern with Fatty Acid-Matched Plant Oils
• Healthy Dietary Pattern with PUFA:SFA Ratio-Matched Plant Oil

Trial Overview The study tests the effects of a healthy diet with different plant oils on heart and metabolic health over four weeks. Participants will consume diets with cottonseed oil or other plant oils matched by certain fatty acid contents.

How Is the Trial Designed?

Group I: Healthy Diet + Cottonseed Oil (CSOD) Experimental Treatment 1 Intervention

Healthy dietary pattern containing 40g/day/2000 kcal of cottonseed oil (CSO)

Group II: Healthy Diet + PUFA:SFA Ratio-Matched Plant Oil (P:S-MD) Active Control 1 Intervention

Healthy dietary pattern containing 40g/day/2000 kcal of plant oil that is lower in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFA) than the CSOD, but with a matched PUFA:SFA ratio and devoid of CSO.

Group III: Healthy Diet + Fatty Acid-Matched Plant Oils (FAMD) Active Control 1 Intervention

Healthy dietary pattern containing 40g/day/2000 kcal of a blend of plant oils comprising a fatty acid profile that matches the CSOD but devoid of CSO

Healthy Dietary Pattern with Cottonseed Oil is already approved in United States, European Union for the following indications:

Approved in United States as Cottonseed Oil for:

• Dietary Management of High Cholesterol
• Prevention of Cardiovascular Diseases

Approved in European Union as Cottonseed Oil for:

• General Health and Wellness
• Cardiovascular Health Support

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Cotton Incorporated

Collaborator

Trials

3

Recruited

240+

Published Research Related to This Trial

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]

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 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]

An 8-week diet intervention with olive oil (MUFA) significantly increased postprandial energy expenditure compared to a diet with cottonseed oil (PUFA) in adults with dyslipidaemia, suggesting potential benefits for weight maintenance.

Both diets showed a lack of metabolic flexibility, which was linked to changes in insulin sensitivity, indicating that while olive oil may enhance energy expenditure, overall metabolic responses were limited in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic responses to 8 weeks of consuming cottonseed oil versus olive oil in adults with dyslipidaemia: a randomised trial. Prater, MC., Scheurell, AR., Paton, CM., et al.[2023]

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]

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]

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).

2. withpower.com withpower.com/trial/healthy-diets-with-plant-oils-for-heart-health-171dc

Healthy Diets With Plant Oils for Heart Health In a study involving 38 healthy adults consuming a cottonseed oil-rich diet for one week, total cholesterol and LDL levels were significantly reduced, ...

3. mdpi.com mdpi.com/2218-1989/15/9/599

Dietary Intervention with Cottonseed and Olive Oil ... This study was a randomized, double-blind, parallel clinical trial with four conditions: high-dose cottonseed oil, low-dose cottonseed oil, high-dose olive oil, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3407983/

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 ...

5. researchgate.net researchgate.net/publication/360408688_Comparison_of_Blood_Lipid_Responses_to_Diets_Enriched_with_Cottonseed_Oil_vs_Olive_Oil_in_Adults_with_High_Cholesterol_in_a_Randomized_Trial

Comparison of Blood Lipid Responses to Diets Enriched ... Comparison of Blood Lipid Responses to Diets Enriched with Cottonseed Oil vs. Olive Oil in Adults with High Cholesterol in a Randomized Trial.

6. ahajournals.org ahajournals.org/doi/10.1161/cir.0000000000000510

Dietary Fats and Cardiovascular Disease: A Presidential ... There were 846 men with a mean age of 65 years, and 30% had CVD. The experimental diet used corn, soybean, safflower, and cottonseed oils ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2212267223014909

No Observed Difference in Inflammatory and Coagulation ... A 5-day high-fat diet rich in cottonseed oil improves cholesterol profiles and triglycerides compared to olive oil in healthy men. Nutr Res, 60 (2018), pp ...