Cottonseed oil eaten a few times a week and heart disease risk factors
Tests cottonseed oil in shakes and snacks in adults with blood fat concerns.
Key facts
- Who runs it
- University of Georgia
- Where
- Athens, United StatesSee the site
- Trial code
- Registry title
- Intermittent Cottonseed Oil Consumption
- Status
- Recruiting
- People taking part
- 75 people, planned
- Started
- 16 Jan 2026
- Expected to end
- May 2029
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- CSO-30
- CSO-20
- Control
- Record updated
- 9 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men and women aged 25 to 75 who are at higher risk of heart disease because of high cholesterol or being overweight or obese.
- Age
- 25 to 75 years
- Sex
- Men and women
- Disease stage
- Raised heart disease risk, shown by high cholesterol or overweight/obesity. Cholesterol limits: total cholesterol 180-239 mg/dL (4.7–6.2 mmol/L) or 240 mg/dL and higher, LDL cholesterol 110-159 mg/dL (2.8–4.1 mmol/L) or 160 mg/dL and higher, triglycerides 130-199 mg/dL (1.5–2.2 mmol/L) or 200-350 mg/dL.
- Earlier treatment
- People cannot join if they take lipid-lowering medicines, diabetes medicines, steroid or hormone therapies, or fish oil supplements. Women on hormone replacement therapy for less than 2 years cannot join.
- Biomarker or test result
- Blood cholesterol: 'borderline high' or 'at risk' in two or more of total cholesterol 180-239 mg/dL (4.7–6.2 mmol/L), LDL cholesterol 110-159 mg/dL (2.8–4.1 mmol/L), triglycerides 130-199 mg/dL (1.5–2.2 mmol/L); or 'high' in total cholesterol (240 mg/dL (6.2 mmol/L) and higher), LDL (160 mg/dL (4.1 mmol/L) or higher) or triglycerides (200-350 mg/dL (2.3–4 mmol/L)).
Main reasons for not taking part
- Pregnant or breastfeeding women
- Chronic diseases, metabolic disease, atherosclerosis, previous heart attack or stroke, or cancer
- Probable familial hypercholesterolemia
- Fasting blood glucose above 126 mg/dL (7 mmol/L) or blood pressure above 180/120 mmHg
- Food allergies to study foods, tobacco or nicotine use, or excessive alcohol use
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Women on hormone replacement therapy less than 2 years
- previous MI or stroke
- 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
- cancer
- medication use affecting digestion, absorption, or 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 soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, and coconut oil)
- 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
- 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
- atherosclerosis
- blood pressure greater than 180/120 mmHg
- medically prescribed or special diets
- 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)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 75 years old?
Where in United States
- University of GeorgiaAthens, United StatesContact: Jamie A Cooper, PhDTaking people
About the trial
What the trial wants to find out
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 and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x/wk)) on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk.
Read full original descriptionShow less
The specific aims are: *Examine the impact of intermittent CSO consumption (3x/week) at two different doses on fasting and postprandial lipids. *Examine the impact of intermittent CSO consumption (3x/week) at two different doses on other markers of chronic disease risk.
Participants will be asked to:
*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. *Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' 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-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.
The 3 groups in the trial
- CSO-30Treatment being tested
Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
- CSO-20Treatment being tested
Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
- ControlPlacebo, for comparison
Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intermittent Cottonseed Oil Consumption on Cardiovascular Disease Risk Reduction
- Plain-language title
- Cottonseed oil eaten a few times a week and heart disease risk factorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07246408, who can take part
- Record updated
- 9 September 2026