Intermittent cottonseed oil intake to improve cholesterol and metabolic risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blinded, randomized controlled feeding trial enrolling adults aged 25–75 at increased cardiovascular risk due to elevated cholesterol or overweight/obesity. Participants are randomly assigned for 56 days to one of three interventions: cottonseed oil at 30% of energy, cottonseed oil at 20% of energy, or a control beverage designed to mimic oil. Study-provided breakfast shakes and snacks deliver the assigned oil dose three times per week, and investigators obtain fasting and postprandial blood samples across six clinic visits to measure lipids and other disease risk markers. The protocol also examines whether a cottonseed-specific fatty acid (dihydrosterculic acid, DHSA) may underlie any observed lipid changes.

Why it matters

Who can join: the full rules

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).

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 or nursing/breastfeeding
* 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, absorption, or 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 soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, and coconut 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)

Where it's running

• University of Georgia
  Athens, Georgia, United States Recruiting

Study contacts

• Principal investigator: Jamie Cooper, PhD — University of Georgia
• Study coordinator: Jamie Cooper, PhD
• Email: jamie.cooper@uga.edu
• Phone: 706-542-4378

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.