💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
HealthTeky