Trial Summary
What is the purpose of this trial?Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease.
The main questions it aims to answer are:
* How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function?
* How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)?
* How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control?
Participants will be asked to:
* Consume provided breakfast shakes and snacks 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 (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.
Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO.
Is cottonseed oil a promising treatment for improving cholesterol levels?Yes, cottonseed oil is a promising treatment for improving cholesterol levels. Studies show that it can lower total cholesterol and LDL (bad cholesterol) in both men and women, which can help reduce the risk of heart disease.12346
What data supports the idea that Cottonseed Oil for Dyslipidemia is an effective treatment?The available research shows that cottonseed oil (CSO) can effectively lower cholesterol levels. In one study, healthy adults who consumed a diet rich in CSO for a week saw a reduction in total cholesterol and LDL (often called 'bad' cholesterol). Another study found that a 5-day high-fat diet with CSO improved cholesterol profiles and triglycerides more than a similar diet with olive oil. Additionally, in a mouse model of fatty liver, a CSO-enriched diet significantly reduced cholesterol and triglycerides in the liver and blood. These findings suggest that CSO can be an effective treatment for improving cholesterol levels.34567
Do I have to stop taking my current medications for the trial?Yes, you may need to stop taking certain medications. The trial excludes participants using medications that affect digestion and absorption, metabolism, lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or those currently on antibiotic cycles.
What safety data is available for cottonseed oil as a treatment for dyslipidemia?The available studies on cottonseed oil (CSO) suggest it is generally safe and may improve cholesterol profiles. In human trials, a CSO-rich diet lowered total and LDL cholesterol without affecting HDL or causing weight changes. In animal studies, CSO improved liver and plasma lipid levels in mice with fatty liver. Another study found no significant inflammatory or coagulation changes in adults consuming CSO. Overall, these studies indicate CSO may be a safe dietary fat option for improving lipid profiles.13456
Eligibility Criteria
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.
My cholesterol levels are either borderline high or high in two or more categories.
Exclusion Criteria
I have very high cholesterol and a family history of early heart attacks.
I have had a heart attack or stroke before.
I am not on medications that affect digestion, metabolism, lower lipids, treat diabetes, or are steroids/hormones.
I have been diagnosed with atherosclerosis.
I have had surgery or have conditions related to my digestive system.
I have a chronic disease like asthma, lung, or kidney disease.
I have cancer.
Treatment Details
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: CSO MIDExperimental Treatment1 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 LOWExperimental Treatment1 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 HIGHExperimental Treatment1 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: CONTROLActive Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of GeorgiaAthens, GA
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Who is running the clinical trial?
University of GeorgiaLead Sponsor
Cotton IncorporatedCollaborator
References
Serum and liver lipids in rats fed diets containing corn oil, cottonseed oil, or a mixture of corn and cottonseed oils. [2019]Previous research has demonstrated that the total replacement of corn oil (CO) with cottonseed oil (CSO) in the diets of growing male rats results in a lowering of the total cholesterol (TC) concentration in the serum. It is not, however, known if a partial replacement of dietary CO with CSO would be sufficient to lower TC levels, nor is the effect of replacing dietary CO with CSO on other indices of cholesterol status (e.g., the levels of high-density lipoprotein cholesterol [HDL-C], non-HDL-C [i.e., very-low and low-density lipoprotein-cholesterol], or the TC/HDL-C ratio). Growing male rats were fed diets having CO, CSO, or a CO/CSO (1:1, w/w) oil mixture (OM) as the source of dietary oil (diet groups CO, CSO, and OM, respectively). There were no differences between CO and OM groups for TC, HDL-C, non-HDL-C, or the TC/HDL-C ratio. However, TC was significantly lower (p
Fatty acid composition of serum, adipose tissue, and liver in rats fed diets containing corn oil or cottonseed oil. [2019]There have been few studies on the effect of cottonseed oil (CSO), one of the most commonly used vegetable oils in the United States, on indices of lipid status either in the rat or in any other species. Previous studies with rats have focused on the effect of CSO, versus that of other vegetable oils, on the concentration of cholesterol in serum and liver or on a limited number of fatty acids in serum, adipose tissue, or liver. The present study was designed to compare more fully than in previous studies the effect of CSO to that of corn oil (CO) on the fatty acid composition of serum, adipose tissue, and liver. Two groups of male rats (n = 10 each) were used, each fed one of two purified diets containing 100 g/kg of either CO or CSO. Between-group differences included higher values (mol% total fatty acids) in adipose tissue for palmitic acid and stearic acid, but lower values in serum, adipose tissue, and liver for cis-vaccenic acid and oleic acid (C18:1n-9) for the CSO group than the CO. In addition, values in serum, adipose tissue, and liver for alpha-linolenic acid (C18:3n-3) and its metabolite, docosahexaenoic acid (C22:6n-3), were lower for the CSO group than the CO. There was no effect of diet on serum or tissue levels of n-6 fatty acids (linoleic acid, dihomo-y-linolenic acid, and arachidonic acid). Differences in fatty acid compositions noted, e.g., those for C18:ln-9 and C22:6n-3, mainly reflected compositional differences between the two oils. Thus, use of CSO rather than CO affected serum and tissue concentrations of saturated, monounsaturated, and n-3 polyunsaturated fatty acids (PUFAs) but had no effect on n-6 PUFA status.
Consumption of a diet rich in cottonseed oil (CSO) lowers total and LDL cholesterol in normo-cholesterolemic subjects. [2021]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. Thirty-eight healthy adults (aged 18-40; 12 males, 26 females) consumed a CSO rich diet (95 g CSO daily) for one week. Anthropometric measurements were obtained, and blood was drawn pre- and post-intervention. Serum lipids (total cholesterol (TC), high density lipoprotein (HDL), low density lipoprotein (LDL), triglyceride (TG), and free fatty acids (FFA)) were assayed. There was no change in weight or waist circumference among participants. There was no change in HDL (Pre: 1.27 ± 0.4 mmol/L; Post: 1.21 ± 0.3 mmol/L) or TG (Pre: 0.91 ± 0.6 mmol/L; Post: 1.06 ± 1.0 mmol/L). Total cholesterol and LDL were reduced (TC Pre: 4.39 ± 0.9 mmol/L; Post: 4.16 ± 0.8 mmol/L; LDL Pre: 2.70 ± 0.8 mmol/L; Post: 2.47 ± 0.6 mmol/L). When data were grouped by sex, total cholesterol was reduced in female participants (Pre: 4.34 ± 0.9 mmol/L; Post: 4.09 ± 0.8 mmol/L). Consumption of a high fat, CSO-rich diet for one week reduced total cholesterol in female participants without reducing HDL.
A 5-day high-fat diet rich in cottonseed oil improves cholesterol profiles and triglycerides compared to olive oil in healthy men. [2019]Modifying dietary fat composition is important for minimizing cardiovascular disease risk. The purpose of this study was to determine the effects of a 5-day, high-fat diet rich in cottonseed oil (CSO) or olive oil (OO) on lipid profiles. Based on previous human and animal models, we hypothesized that the CSO-rich diet would lead to lower fasting and postprandial lipid levels, whereas the OO-rich diet would not significantly change lipid levels in 5 days. Fifteen normal-weight men completed a randomized crossover design with 2 controlled feeding trials (3-day lead-in diet, prediet visit, 5-day CSO- or OO-rich diet, postdiet visit). The 5-day diets (50% fat) were rich in either CSO or OO. At pre- and postdiet visits, subjects consumed test meals rich in the oil that coincided with their 5-day diet, and blood draws were performed. Fasting total cholesterol, low-density lipoprotein cholesterol, and triglycerides (TG) were lower following CSO diet intervention (total cholesterol: 148.40 ± 6.39 to 135.93 ± 6.31 mg/dL; low-density lipoprotein cholesterol: 92.20 ± 5.57 to 78.13 ± 5.60 mg/dL; TG: 80.11 ± 4.91 to 56.37 ± 5.46 mg/dL for pre- to postdiet, respectively; P
A cottonseed oil-enriched diet improves liver and plasma lipid levels in a male mouse model of fatty liver. [2023]A high-fat (HF) diet causes fatty liver, hyperlipidemia, and hypercholesterolemia, and cottonseed oil (CSO) has been shown to improve liver and plasma lipids in human and mouse models. The purpose of this study was to determine the effect of CSO vs. olive oil (OO)-enriched diets on lipid levels in a HF-diet model of fatty liver disease. We placed mice on a HF diet to induce obesity and fatty liver, after which mice were placed on CSO or OO diets, with chow and HF (5.1 kcal/g) groups as control. When CSO- and OO-fed mice were given isocaloric diets with the HF group, there were no differences in body weight, plasma, or hepatic lipids. However, when the CSO and OO diets were reduced in calories (4.0 kcal/g), CSO and OO groups reduced body weight. 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 ± 16%, P = 0.01) vs. HF group whereas the OO diet lowered LDL (-18 ± 12%, P = 0.05) vs. HF. Furthermore, the CSO diet decreased hepatic total cholesterol (-40 ± 12%, P < 0.01), free cholesterol (-23 ± 11%, P = 0.04), and triglycerides (-47 ± 12%, P = 0.02). There were no significant changes in lipogenesis and fatty acid oxidation among the groups. However, the CSO group increased lipid oxidative gene expression in liver and dihydrosterculic acid increased PPARα target genes with in vitro models. Taken together, consuming a reduced calorie diet enriched in CSO reduces liver and plasma lipid profiles in an obese model of fatty liver.
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]Inflammatory and prothrombotic responses are hallmark to the progression of cardiovascular disease and may be influenced by the type of dietary fat. Cottonseed oil (CSO) is rich in n-6 polyunsaturated fats and improves traditional cardiovascular disease risk factors such as cholesterol profiles. However, some clinicians are still hesitant to promote n-6 polyunsaturated fats consumption despite growing evidence suggesting they may not be independently pro-inflammatory.
The effect of cottonseed oil on lipids/lipoproteins: a systematic review and plasma cholesterol predictive equations estimations. [2023]Cottonseed oil (CSO) is higher in polyunsaturated fatty acids (PUFA) and saturated fatty acids (SFAs) than many liquid plant oils.