Cottonseed Oil Versus Matched PUFA Effects

Launched by UNIVERSITY OF GEORGIA · Apr 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of cottonseed oil compared to a similar diet made up of other healthy fats, known as polyunsaturated fatty acids (PUFA). The goal is to see if cottonseed oil can improve cholesterol levels and other health markers in people who are at higher risk for heart disease, often due to being overweight or having elevated cholesterol levels. Participants will be asked to drink meal replacement shakes that contain cottonseed oil or PUFA for 28 days and will have regular check-ins to measure their blood and body changes.

To be eligible for this study, participants should be between 25 and 75 years old and have either high cholesterol or a body mass index (BMI) over 25, which means they are considered overweight. However, some individuals may not qualify, such as those with certain medical conditions, recent weight changes, or specific dietary restrictions. Throughout the trial, participants will also undergo blood tests and health assessments to track how their bodies respond to the different oils. This study could help researchers understand if cottonseed oil offers unique health benefits compared to other oils.

Gender

ALL

Eligibility 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 of 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 \>25 kg/m².
• 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 less than 2 years.
• • Women who are pregnant
• • individuals who regularly exercise more than 3h/w
• • weight gain or loss of more than 5% 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 disease
• • 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 an 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/day for men; greater than 2 drinks/day for women)
• • tobacco or nicotine use
• • underweight BMI (\<18.5 kg/m²)