An interventional study of CSO-30 and CSO-20 in Dyslipidemia, Overweight and Obesity and Nutrition, Healthy, sponsored by University of Georgia. Recruiting at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Georgia · Not applicable, Interventional, and Prevention
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.
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.
Accounting for nearly 1 in every 4 deaths in the U.S., cardiovascular disease (CVD) is the leading cause of death for adults. One risk factor for CVD is hypercholesterolemia, which can double the risk for this disease. Cottonseed oil is a rich source of polyunsaturated fatty acids (PUFAs). Despite having a relatively high amount of saturated fatty acids, preliminary studies demonstrate that incorporating CSO into a diet at 30% and 20% of daily energy needs is sufficient to reduce blood lipid profiles and select postprandial measures of metabolism. These improvements in lipid metabolism may be due to the general fatty acid (FA) composition of CSO; however, evidence shows that a fatty acid unique to CSO, dihydrosterculic acid (DHSA), may be responsible for some, if not all, of the positive lipid lowering effects.
This prospective clinical study is a double-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles and/or overweight/obesity). There are three diet interventions: CSO-30 (30% of energy needs from CSO), CSO-20 (20% of energy needs from CSO), and Control (not receiving CSO; will receive thickened water with yellow food coloring to mimic the appearance of oil). The study protocol consists of a 56-day intervention where participants are provided breakfast shakes and snacks that contain different amounts of oil, depending on the participant's random group assignment.
There are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 bi-weekly (every other week) short visits (v2, v3, v4), and post-intervention (v5).
At screening (v0), qualification is confirmed based on anthropometrics and a fasting blood draw, which is analyzed for a cholesterol panel and blood glucose. Additionally, energy requirements are estimated at this visit for use in the diet intervention.
At v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA). Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35% of the participant's estimated energy needs.
56-day dietary intervention: Participants will consume a shake and snack 3 times per week, corresponding to the participant's randomly assigned group. The ingredients for the breakfast shakes and snacks are identical between groups, the only difference being the amount of assigned oil provided. The breakfast shakes and snacks are portioned based on individual energy needs as estimated at v0.
Participants return every other week (v2, v3, v4), to return study materials and collect shakes and snacks for the next two weeks. At these bi-weekly visits, participants also have a fasting blood draw and body measures taken.
At the end of the 56-day dietary intervention, participants return for v5, where all procedures from v1 are repeated.
As decided a priori, we will complete a per protocol analysis.
The investigators hypothesize that CSO-30 and CSO-20 will improve the proposed overall health outcomes and markers of chronic disease risk without changing inflammatory markers or coagulation potential compared to the control group.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's planned enrollment of 75 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →University of Georgia is the lead sponsor of 74 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
Other: CSO-30
Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
Other: CSO-20
Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance.
Other: Control
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 30% of participant's daily estimated energy needs as cottonseed oil for 56 days.
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 20% of participant's daily estimated energy needs as cottonseed oil for 56 days.
Participants are provided a breakfast shake and snack to consume 3 times per week that does not contain cottonseed oil, but does contain thickened water for blinding purposes, for 56 days.
Change in fasting serum lipoprotein and cholesterol concentrations
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma triglyceride concentrations
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)
Time frame: baseline, 8 weeks
Change in fasting serum hepatic enzymes
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L)
Time frame: baseline, 8 weeks
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL)
Time frame: baseline, 8 weeks
Change in fasting serum bilirubin
Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma insulin concentrations
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post- intervention visits (uU/mL)
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (ng/mL)
Time frame: baseline, 8 weeks
Change in fasting plasma markers of coagulation potential
The concentration of plasminogen activator inhibitor-1, fibrinogen, tissue factor Von Willebrand factor, tissue factor pathway inhibitor, and D-dimer at fasting for both pre- and post-intervention visits (pg/mL).
Time frame: baseline, 8 weeks
Change in fasting inflammatory cytokine concentrations
The concentration of interleukin-1 beta, C-reactive protein, tumor-necrosis factor-alpha, interleukin-10, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma total antioxidant capacity
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma Malondialdehyde (MDA)
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).
Time frame: baseline, 8 weeks
Change in fasting and postprandial subjective feelings related to appetite
Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma appetite control hormone concentrations
The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL)
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma glucose concentrations
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg/dL)
Time frame: baseline, 8 weeks
Change in acute dietary intake
One-day food logs will be used to record all foods and beverages consumed on testing days
Time frame: baseline, 8 weeks
Change in fasting insulin resistance metrics
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and homeostatic model assessment for beta cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 56-day intervention.
Time frame: baseline, 8 weeks
Desaturation index
Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids)
Time frame: baseline, 8 weeks
Change in blood pressure
Systolic and diastolic blood pressure (mmHg)
Time frame: baseline, 8 weeks
Change in body weight
body weight (kg)
Time frame: baseline, 8 weeks
Change in body composition
DXA will be used to measure body fat percentage (body fat %)
Time frame: baseline, 8 weeks
Change in diet composition
3-day food records will be used to record foods and beverages consumed before and during the 56-day intervention period
Time frame: baseline, week 4, week 8
Change in fasting tocopherol concentrations
Plasma tocopherol concentrations (ug/mL)
Time frame: baseline, 8 weeks
Change in anthropometric circumferences
hip and waist circumferences (cm)
Time frame: baseline, 8 weeks
Resting metabolic rate
Resting metabolic rate (RMR) will be measured for 30 minutes on the TrueOne 2400 (Parvo Medics, Sandy, UT)
Time frame: Screening
Change in Perceived Stress
Perceived Stress Scale will be administered and scored to determine stress levels
Time frame: baseline, 8 weeks
Change in anxiety
The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels
Time frame: baseline, 8 weeks
Change in self reported physical activity levels
The International Physical Activity Questionnaire will be used to collect self-reported average physical activity levels (met/min)
Time frame: baseline, week 4, week 8
Change in Body Mass Index (BMI)
BMI will be calculated based on height and weight measures (kg/m²)
Time frame: baseline, 8 weeks
Change in highly processed food (HPF) consumption
The Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF) will be administered and scored to determine HPF consumption
Time frame: baseline, 8 weeks
Change in pro-inflammatory and anti-inflammatory food consumption
The Anti-Inflammatory Diet Index-20 (AIDI-20) Inspired Questionnaire will be administered and scored to determine pro-inflammatory and anti-inflammatory food consumption
Time frame: baseline, 8 weeks
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