Actively Recruiting
Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans
Led by University of Georgia · Updated on 2025-08-17
90
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
Sponsors
U
University of Georgia
Lead Sponsor
U
United States Department of Agriculture (USDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiovascular disease is a leading cause of death in the United States, with risk factors like higher body mass index (BMI) and poor cholesterol profiles increasing disease burden. Researchers are studying cottonseed oil (CSO), which has shown potential in improving cholesterol and lipid metabolism, to compare its effects against a diet matched for polyunsaturated fatty acids (PUFA) and a control oil mixture. This study aims to assess how CSO influences fasting and postprandial lipid levels and other markers related to chronic disease risk in adults at increased risk for cardiovascular disease. Participants will be randomly assigned to one of three groups receiving daily breakfast shakes over 28 days: a shake enriched with cottonseed oil, a shake with oils matched for fatty acid composition to CSO (PUFA), or a shake matching the fatty acid profile of the average American diet (control). The shakes provide 20% of the participant's daily estimated energy needs. Weekly visits include fasting blood draws, body measurements, and study material collection. Two longer visits involve consuming a standardized meal and multiple blood draws to assess metabolic responses. Throughout the study, participants will undergo screening and pre- and post-intervention assessments including blood tests for cholesterol, triglycerides, fatty acids, inflammatory markers, and other health indicators. Body composition will be measured by DXA scans. Researchers will monitor changes in fasting and postprandial lipid metabolism and other chronic disease markers to evaluate the effects of CSO compared to matched PUFA and control diets. The total study duration includes a 28-day intervention with multiple follow-up visits and testing sessions.
CONDITIONS
Brief Title
Cottonseed Oil Versus Matched PUFA Effects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 25 to 75 years at increased risk for cardiovascular disease
- Increased risk defined by elevated cholesterol profiles or overweight/obesity
- Elevated cholesterol includes borderline high or at risk in two or more variables: total cholesterol 180-239 mg/dL, LDL 110-159 mg/dL, triglycerides 130-199 mg/dL
- High cholesterol defined as total cholesterol 240 mg/dL or higher, LDL 160 mg/dL or higher, or triglycerides 200-350 mg/dL
- Overweight or obesity defined as body mass index greater than 25 kg/m²
You will not qualify if you...
- Probable familial hypercholesterolemia: 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
- Pregnant women
- Individuals exercising more than 3 hours per week regularly
- Recent weight gain or loss over 5% in last 3 months
- Plans to start a 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, metabolism, lipid levels, diabetes, steroids, hormones, or current antibiotics
- Medically prescribed or special diets
- Food allergies relevant to the study foods including wheat, dairy, cottonseed oil
- Use of fish oil supplements
- Excessive alcohol use (more than 3 drinks/day for men, more than 2 for women)
- Tobacco or nicotine use
- Underweight with BMI less than 18.5 kg/m²
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline measurements including body composition and blood draws before starting the diet intervention.
1 visit (in-person)
Duration - 28 days
Participants consume a daily breakfast shake with assigned oil composition for 28 days to study effects on cardiovascular risk markers.
Weekly visits for 3 weeks to return study materials, collect shakes, have fasting blood draws, body measures, and consume the shake in the lab
Duration - 1 day
Participants repeat baseline measurements including body composition and blood draws after completing the 28-day diet intervention.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Georgia
Athens, Georgia, United States, 30602
Actively Recruiting
Research Team
J
Jamie Cooper, PhD
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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