Cottonseed Oil Dose Response

Completed · Not applicable

Conditions studied: Dyslipidemias, Overweight and Obesity, Nutrition, Healthy

In brief

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease. The main questions it aims to answer are: * How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function? * How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)? * How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control? Participants will be asked to: * Consume provided breakfast shakes and snacks 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 (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO.

Key facts

Study ID

NCT05686954

Run by

University of Georgia

People needed

95

Starts

2023-03-01

Expected to finish

2024-05-02

Last updated by the study team

2026-05-04

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 or 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 (overweight 25-29.9 kg/m2 or obesity 30 kg/m2 or greater).

You may not qualify if…

• 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 for less than 2 years
• women who are pregnant
• individuals who regularly exercise more than 3 h/w
• weight gain or loss of more than 5% of their 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 diseases
• 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 and 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/d for men; greater than 2 drinks/d for women)
• tobacco or nicotine use
• underweight BMI (<18.5 kg/m2)

Where it is running

• University of Georgia — Athens, Georgia, United States

Full record on ClinicalTrials.gov

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