NCT07246408 · University of Georgia
Intermittent Cottonseed Oil Consumption
What this study is about
Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden.
View original scientific description
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 and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x/wk)) on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk. The specific aims are: \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on fasting and postprandial lipids. \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on other markers of chronic disease risk. Participants will be asked to: \*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. \*Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' 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-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.
Interventions
OTHER
CSO-30
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 30% of participant's daily estimated energy needs as cottonseed oil for 56 days.
OTHER
CSO-20
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 20% of participant's daily estimated energy needs as cottonseed oil for 56 days.
OTHER
Control
Participants are provided a breakfast shake and snack to consume 3 times per week that does not contain cottonseed oil, but does contain thickened water for blinding purposes, for 56 days.
Primary outcome measures
Change in fasting serum lipoprotein and cholesterol concentrations
Time frame: baseline, 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 concentrations
Time frame: baseline, 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) concentrations
Time frame: baseline, 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 concentrations
Time frame: baseline, 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 appetite
Time frame: baseline, 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)
Time frame: 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 capacity
Time frame: baseline, 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 concentrations
Time frame: baseline, 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 potential
Time frame: baseline, 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) proteins
Time frame: baseline, 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
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 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
- 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)
Where
- Athens, Georgia
Collaborators
Cotton Incorporated
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations