Recruiting

CSO vs. PUFA

Sponsor:

University of Georgia

Code:

NCT06382298

Conditions

Dyslipidemia

Overweight and Obesity

Nutrition, Healthy

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

COTTONSEED OIL

MATCHED PUFA DIET

CONTROL

Study Details

Brief summary:

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

Dyslipidemia

Overweight and Obesity

Nutrition, Healthy

Study ID

NCT06382298

Start date

Aug 31, 2024

Status verified date

Sep, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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).

Overweight/obesity will be defined by body mass index >25 kg/m².

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
  • 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 an absorption, 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 wheat, dairy, and cottonseed 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)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: COTTONSEED OIL

Participants are given a daily shake enriched with cottonseed oil and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

experimental: MATCHED PUFA DIET

Participants are given a daily shake enriched with a mixture of oils with a similar fatty acid profile to CSO and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

active comparator: CONTROL

Participants are given a daily shake enriched with a mixture of oils that match the fatty acid profile of the average American diet, and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.

Interventions

COTTONSEED OIL

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.

MATCHED PUFA DIET

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs from oils with similar fatty acid composition as CSO for 28 days.

CONTROL

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.

Primary outcome measure

  • Change in fasting serum lipoprotein and cholesterol concentrations [ Time Frame: baseline, 4 weeks ]
  • Change in fasting and postprandial plasma triglyceride concentrations [ Time Frame: baseline, 4 weeks ]
  • Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations [ Time Frame: baseline, 4 weeks ]

Central Contacts and Locations

Central contacts

Jamie Cooper, PhD

706-542-4378jamie.cooper@uga.edu

Locations

University of Georgia

Recruiting

Athens, Georgia, United States, 30602

Contacts

Jamie A Cooper, Ph.D.

706-542-4378jamie.cooper@uga.edu

Principal Investigator:

Jamie A Cooper, Ph.D.

More Information

Sponsor

University of Georgia

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Georgia on 2026-09-09.