Intermittent cottonseed oil intake to improve cholesterol and metabolic risk
Intermittent Cottonseed Oil Consumption on Cardiovascular Disease Risk Reduction
NA · University of Georgia · NCT07246408
This trial will test whether taking cottonseed oil three times a week at two different doses can improve fasting and after-meal blood lipids and other risk markers in adults with high cholesterol or who are overweight.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | University of Georgia (other) |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT07246408 on ClinicalTrials.gov |
What this trial studies
This is a double-blinded, randomized controlled feeding trial enrolling adults aged 25–75 at increased cardiovascular risk due to elevated cholesterol or overweight/obesity. Participants are randomly assigned for 56 days to one of three interventions: cottonseed oil at 30% of energy, cottonseed oil at 20% of energy, or a control beverage designed to mimic oil. Study-provided breakfast shakes and snacks deliver the assigned oil dose three times per week, and investigators obtain fasting and postprandial blood samples across six clinic visits to measure lipids and other disease risk markers. The protocol also examines whether a cottonseed-specific fatty acid (dihydrosterculic acid, DHSA) may underlie any observed lipid changes.
Who should consider this trial
Good fit: Adults aged 25–75 with increased cardiovascular risk defined by overweight/obesity or elevated cholesterol (e.g., total cholesterol 180–239 mg/dL, LDL 110–159 mg/dL, triglycerides 130–199 mg/dL, or higher ranges specified in the protocol) are the intended participants.
Not a fit: People with probable familial hypercholesterolemia, pregnant or breastfeeding women, or those meeting the study's exclusion criteria (such as recent hormone replacement therapy) are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, intermittent cottonseed oil could lower cholesterol and other metabolic risk markers and potentially reduce cardiovascular risk through a simple dietary change.
How similar studies have performed: Previous pilot work by the investigators reported that diets containing cottonseed oil at 20–30% of energy improved blood lipids, but intermittent, lower-frequency dosing as tested here is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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)
Where this trial is running
Athens, Georgia
- University of Georgia — Athens, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Jamie Cooper, PhD — University of Georgia
- Study coordinator: Jamie Cooper, PhD
- Email: jamie.cooper@uga.edu
- Phone: 706-542-4378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyslipidemia, Overweight and Obesity, Nutrition, Healthy