Oil Consumption and Cholesterol

Completed · Not applicable

Conditions studied: Hypercholesterolemia

In brief

More than 31 million U.S. adults have high total cholesterol and over 73 million U.S. adults have high LDL cholesterol. Cottonseed oil (CSO) is found readily in our food supply, and recent research has shown improvements in blood lipids following CSO consumption in healthy adults with normal cholesterol profiles. To date, however, there are no published studies on the effects of CSO-enriched diets on blood lipids and markers of health in an older population with hypercholesterolemia. Therefore, the purpose of this study is to test the health effects of a diet rich in CSO against a diet rich in olive oil to determine if the CSO-enriched diet will show greater improvements in blood lipids and other health markers in adults with high cholesterol levels. If CSO in the diet is found to improve these markers, these study findings could lead to improvements in health.

Key facts

Study ID

NCT04397055

Run by

University of Georgia

People needed

112

Starts

2018-05-14

Expected to finish

2021-06-08

Last updated by the study team

2023-05-10

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 30-75 year old
• body mass index (BMI) between 18.5-39.9 kg/m2
• higher cholesterol levels indicated by "At Risk/Borderline High" in two or more of the variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher), and having triglyceride levels less than 350mg/dL.

You may not qualify if…

• participants with familial hypercholesterolemia
• LDL levels greater than the 95th percentile based on age and sex
• HDL levels lower than the 20th percentile based on age and sex
• women on hormone replacement therapy for less than 2 years
• individuals who regularly exercise more than 3 h/w
• weight gain or loss more than 5% of their body weight in the past 3 months
• plans to begin a weight loss/exercise regiment during the trial
• history of medical or surgical events that could affect digestion or swallowing
• gastrointestinal surgeries
• conditions or disorders
• any chronic or 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
• medication use affecting metabolism (e.g. thyroid meds)
• lipid-lowering medications
• medications for diabetes
• steroid/hormone therapies
• a medically prescribed or special diet
• food allergies (specific for the foods made in the study)
• taking fish oil and calciumfloroboron supplements
• excessive alcohol use (greater than 3 drinks/d for men; greater than 2 drinks/d for women)

Where it is running

• University of Georgia — Athens, Georgia, United States

Full record on ClinicalTrials.gov

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