Actively Recruiting
Intermittent Cottonseed Oil Consumption
Led by University of Georgia · Updated on 2026-01-23
75
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
Sponsors
U
University of Georgia
Lead Sponsor
C
Cotton Incorporated
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Intermittent Cottonseed Oil Consumption
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 25 to 75 years at increased risk for cardiovascular disease due to elevated cholesterol or overweight/obesity
- Elevated cholesterol defined as either borderline high or at risk in two or more of total cholesterol (180-239 mg/dL), LDL cholesterol (110-159 mg/dL), or triglycerides (130-199 mg/dL)
- Or high cholesterol levels with total cholesterol 240 mg/dL or higher, LDL 160 mg/dL or higher, or triglycerides between 200-350 mg/dL
You will not qualify if you...
- Probable familial hypercholesterolemia defined by total cholesterol over 290 mg/dL or LDL over 190 mg/dL plus family history of early myocardial infarction
- Women on hormone replacement therapy for less than 2 years
- Women who are pregnant or breastfeeding
- Regular exercise over 3 hours per week
- Weight change over 5% in past 3 months
- Plans to start weight loss or exercise program during the trial
- History of medical or surgical conditions affecting digestion or swallowing
- Gastrointestinal surgeries, conditions, or disorders
- Chronic diseases including moderate to severe asthma, chronic lung disease, kidney disease
- Metabolic disease, atherosclerosis, previous myocardial infarction or stroke, cancer
- Fasting blood glucose over 126 mg/dL
- Blood pressure over 180/120 mmHg
- Use of medications affecting digestion, absorption, metabolism, lipid-lowering, diabetes, steroid/hormone therapy, or antibiotics
- Medically prescribed or special diets
- Allergies to study foods including soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, coconut oil
- Use of fish oil supplements
- Excessive alcohol consumption (over 3 drinks/day for men, over 2 drinks/day for women)
- Tobacco or nicotine use
- Underweight BMI below 18.5 kg/m2
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Georgia
Athens, Georgia, United States, 30602
Actively Recruiting
Research Team
J
Jamie Cooper, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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