Cottonseed Oil for Cardiovascular Disease Risk Factors

This study is looking at how consuming cottonseed oil (CSO) intermittently affects blood fats like cholesterol and triglycerides. Researchers want to see if adding CSO to your diet a few times a week can improve these markers, especially if you're at higher risk for heart disease due to elevated cholesterol or being overweight/obese. You would receive a breakfast shake and snack three times a week for 56 days. Some participants will get shakes with CSO (at 20% or 30% of daily energy needs), while others will get a control shake without CSO. The main goal is to measure changes in your fasting and after-meal blood fat levels over 8 weeks. This study is for adults aged 25-75 with certain cholesterol levels or who are overweight/obese.

Study design
This is a double-blinded, randomized control trial involving 75 participants. This means neither you nor the study staff will know which intervention you are receiving, and participants are assigned to groups by chance.
What's involved
You would consume a provided breakfast shake and snack three times per week for 56 days. Your blood fat levels will be measured at the beginning of the study and again after 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your blood fat levels will be measured at the beginning of the study and after 8 weeks.

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NCT07246408

Intermittent Cottonseed Oil Consumption

Recruiting
NAAges 25–75InterventionalPrevention
University of Georgia
~75 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:CSO-30CSO-20Control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in fasting serum lipoprotein and cholesterol concentrations
Measured over baseline, 8 weeks
+9 more outcomes measured
Dyslipidemia
Overweight and Obesity
Nutrition, Healthy
1 sites across 1 states
Georgia1
  • Jamie Cooper, PhD · PRINCIPAL_INVESTIGATOR · University of Georgia

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Eligibility criteria

Inclusion

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).

Exclusion

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 or nursing/breastfeeding
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, absorption, or 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 soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, and coconut 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)
  • Change in fasting serum lipoprotein and cholesterol concentrationsbaseline, 8 weeks

    The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)

  • Change in fasting and postprandial plasma triglyceride concentrationsbaseline, 8 weeks

    The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)

  • Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrationsbaseline, 8 weeks

    The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)

  • Change in fasting and postprandial plasma appetite control hormone concentrationsbaseline, 8 weeks

    The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL)

  • Change in fasting and postprandial subjective feelings related to appetitebaseline, 8 weeks

    Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).

  • Change in fasting and postprandial plasma Malondialdehyde (MDA)baseline, 8 weeks

    The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).

  • Change in fasting and postprandial plasma total antioxidant capacitybaseline, 8 weeks

    Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).

  • Change in fasting inflammatory cytokine concentrationsbaseline, 8 weeks

    The concentration of interleukin-1 beta, C-reactive protein, tumor-necrosis factor-alpha, interleukin-10, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).

  • Change in fasting plasma markers of coagulation potentialbaseline, 8 weeks

    The concentration of plasminogen activator inhibitor-1, fibrinogen, and tissue factor at fasting for both pre- and post-intervention visits (pg/mL)

  • Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteinsbaseline, 8 weeks

    The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (ng/mL)