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RecruitingDyslipidemiaOverweight and ObesityNutrition, Healthy

Cottonseed Oil Versus Matched PUFA Effects

Eligible age

25–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. The specific aims are: * Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. * Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: * Consume provided meal replacement shakes 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 (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.

Sponsor: University of Georgia

You may qualify if…

  • 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.

You may not qualify if…

  • 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

Where it's recruiting

Georgia

Athens

Source: ClinicalTrials.gov · NCT06382298 · last updated 2025-08-17