Cottonseed Oil for Dyslipidemia
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.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes people using medications that affect digestion, metabolism, lipid levels, diabetes, and certain hormone therapies.
What data supports the effectiveness of the treatment Cottonseed Oil for Dyslipidemia?
Is cottonseed oil safe for human consumption?
Research involving healthy adults consuming a diet rich in cottonseed oil for a short period showed no adverse effects on weight or waist circumference, suggesting it is generally safe. Additionally, studies indicate that cottonseed oil may improve cholesterol levels without causing inflammation, which supports its safety in humans.12346
How does the treatment with cottonseed oil for dyslipidemia differ from other treatments?
Cottonseed oil (CSO) is unique because it is a dietary treatment that can lower total and LDL cholesterol levels without affecting HDL cholesterol, unlike many traditional medications. It is rich in n-6 polyunsaturated fats, which are not typically associated with inflammation, making it a novel option for improving cholesterol profiles.12467
Research Team
Jamie A Cooper, Ph.D.
Principal Investigator
University of Georgia
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-intervention
Participants undergo baseline measurements and a high-saturated-fat meal challenge
Dietary Intervention
Participants consume provided breakfast shakes and snacks daily for 28 days, with weekly visits for fasting blood draws and body measurements
Post-intervention
Participants repeat baseline measurements and meal challenge to assess changes
Follow-up
Participants are monitored for safety and effectiveness after the intervention
Treatment Details
Interventions
- CONTROL (Other)
- CSO HIGH (Other)
- CSO LOW (Other)
- CSO MID (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Georgia
Lead Sponsor
Cotton Incorporated
Collaborator