NCT06382298Recruiting
Cottonseed Oil Versus Matched PUFA Effects
Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of 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 vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 19 Apr 2024
- Start date
- 31 Aug 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Georgia
- Diseases
- Obesity
- NCT number
- NCT06382298
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 31 Aug 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women on hormone replacement therapy less than 2 years.
- previous MI or stroke
Other illness
- 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
- cancer
- medication use affecting digestion an absorption, metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
- Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil)
Lab values
- 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.
- fasting blood glucose levels greater than 126 mg/dL
Other
- 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
- atherosclerosis
- blood pressure greater than 180/120 mmHg
- medically prescribed or special diets
- 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)
Who the study is looking for
- 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.
Age in the registry: 25 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Georgia Coordinator of this site? Confirm its status | Athens | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.