Actively Recruiting

Phase Not Applicable
Age: 25Years - 75Years
All Genders
Healthy Volunteers
NCT06382298

Cottonseed Oil Versus Matched PUFA Effects

Led by University of Georgia · Updated on 2025-08-17

90

Participants Needed

1

Research Sites

191 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 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.

CONDITIONS

Official Title

Cottonseed Oil Versus Matched PUFA Effects

Who Can Participate

Age: 25Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 25 to 75 years old at increased risk for cardiovascular disease
  • Increased risk defined by elevated cholesterol profiles or overweight/obesity
  • Elevated cholesterol defined as borderline high or at risk in two or more of: total cholesterol 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL
  • Or high cholesterol: total cholesterol 240 mg/dL or higher, LDL 160 mg/dL or higher, or triglycerides 200-350 mg/dL
  • Overweight or obesity defined by body mass index greater than 25 kg/m²
Not Eligible

You will not qualify if you...

  • Probable familial hypercholesterolemia with total cholesterol above 290 mg/dL or LDL above 190 mg/dL plus family history of early myocardial infarction
  • Women on hormone replacement therapy for less than 2 years
  • Pregnant women
  • Individuals who exercise more than 3 hours per week
  • Weight change over 5% in the past 3 months
  • Plans to start weight loss or exercise regimen during the trial
  • History of medical or surgical issues affecting digestion or swallowing
  • Gastrointestinal surgeries, conditions, or disorders
  • Any 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 antibiotics
  • Special medically prescribed diets
  • Food allergies to 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 drinks/day for women)
  • Tobacco or nicotine use
  • Underweight with BMI less than 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

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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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