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Compares treatment options for Dyslipidemia
Official title Cottonseed Oil Versus Matched PUFA Effects
ClinicalTrials.gov ID: NCT06382298
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 75. Healthy volunteers may be eligible.
You may be able to join 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 will be defined as: -"Borderline High" and/or "at risk" in two of more of the following variables (total cholesterol...
- "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...
You likely can't join if
- Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family...
- 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
See the full eligibility 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...
- "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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.