NCT05686954Completed
Cottonseed Oil Dose Response
Nutritional Effects of Different Doses of Cottonseed Oil in Humans
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 95 (actual)
- First submitted
- 5 Jan 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 2 May 2024
- Lead sponsor
- University of Georgia
- Diseases
- Obesity
- NCT number
- NCT05686954
What you commit to
- Study type: Interventional
- Participants enrolled: 95
- From 1 Mar 2023 to the primary completion date, 2 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- women on hormone replacement therapy for less than 2 years
- previous MI or stroke
Other illness
- 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
- cancer
- medication use affecting digestion and absorption, metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
- Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil)
Lab values
- 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.
- fasting blood glucose levels greater than 126 mg/dL
Other
- 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
- atherosclerosis
- blood pressure greater than 180/120 mmHg
- medically prescribed or special diets
- 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)
Who the study is looking for
- 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).
Age in the registry: 25 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Georgia Coordinator of this site? Confirm its status | Athens | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.