Effects of cottonseed oil on cholesterol and health markers
Nutritional Effects of Different Doses of Cottonseed Oil in Humans
This study is testing whether adding different amounts of cottonseed oil to the diets of adults at risk for heart disease can improve their cholesterol levels and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | University of Georgia Academic / other |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT05686954 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the health effects of varying amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease. Participants will be randomly assigned to consume diets with different energy contributions from CSO (10%, 20%, or 30%) or a control oil mix. The study aims to assess how these dietary interventions impact fasting cholesterol profiles, lipid metabolism, glycemic control, and markers of chronic disease risk. By exploring lower doses of CSO, the trial seeks to determine if they can provide similar health benefits as previously established higher doses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-75 with elevated cholesterol profiles or those classified as overweight or obese.
Not a fit: Patients with familial hypercholesterolemia or significantly elevated cholesterol levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to dietary recommendations that improve cholesterol levels and reduce cardiovascular disease risk in at-risk populations.
How similar studies have performed: Previous studies have shown that higher doses of cottonseed oil can improve cholesterol profiles, but the effects of lower doses are novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 25-75-year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight/obesity. * Elevated cholesterol profiles will be 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). Overweight/obesity will be defined by body mass index (overweight 25-29.9 kg/m2 or obesity 30 kg/m2 or greater). Exclusion Criteria: * Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative. * women on hormone replacement therapy for less than 2 years * women who are pregnant * individuals who regularly exercise more than 3 h/w * weight gain or loss of more than 5% of their body weight in the past 3 months * plans to begin a weight loss/exercise regimen during the trial * history of medical or surgical events that could affect digestion or swallowing * gastrointestinal surgeries, conditions or disorders, * any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease), * metabolic diseases * atherosclerosis * previous MI or stroke * cancer * fasting blood glucose levels greater than 126 mg/dL * blood pressure greater than 180/120 mmHg * medication use affecting digestion and absorption, metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles * medically prescribed or special diets * Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil) * fish oil supplements, * excessive alcohol use (greater than 3 drinks/d for men; greater than 2 drinks/d for women) * tobacco or nicotine use * underweight BMI (\<18.5 kg/m2)
Where this trial is running
Athens, Georgia
- University of Georgia — Athens, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Jamie A Cooper, Ph.D. — University of Georgia
- Study coordinator: Jamie A Cooper, Ph.D.
- Email: jamie.cooper@uga.edu
- Phone: 706-542-4903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.