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

Trial Summary

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.

What data supports the effectiveness of the treatment Healthy Dietary Pattern with Cottonseed Oil for heart health?

Research shows that a diet rich in cottonseed oil can lower total cholesterol and LDL (bad cholesterol) levels, which are important for heart health. In studies, participants consuming cottonseed oil had improved cholesterol profiles compared to those consuming olive oil, suggesting potential heart health benefits. ^{1 2 3 4 5}

Is a diet rich in cottonseed oil safe for humans?

Research shows that consuming a diet rich in cottonseed oil is generally safe for humans, as it can lower cholesterol levels without causing weight gain or changes in waist circumference. Additionally, it does not appear to increase inflammation or blood clotting risks. ^{1 2 3 6 7}

How does the Healthy Dietary Pattern with Cottonseed Oil treatment differ from other treatments for heart health?

This treatment is unique because it uses cottonseed oil, which is rich in polyunsaturated fats, to improve cholesterol levels and reduce triglycerides, potentially offering better heart health benefits compared to other plant oils like olive oil. ^{1 2 3 4 6}

What is the purpose of this trial?

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

Eligibility Criteria

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

Blood pressure <140/90 mmHg

LDL-C ≥100 mg/dL and ≤190 mg/dL

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

I have been diagnosed with a liver, kidney, or autoimmune disease.

Lactation within prior 6 months

Timeline

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Metabolic responses to 8 weeks of consuming cottonseed oil versus olive oil in adults with dyslipidaemia: a randomised trial. [2023]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fatty acid composition of serum, adipose tissue, and liver in rats fed diets containing corn oil or cottonseed oil. [2019]