An interventional study of COTTONSEED OIL and MATCHED PUFA DIET 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 cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.
The specific aims are:
Participants will be asked to:
Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.
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 poly-unsaturated fatty acids (PUFAs). Despite having a relatively high amount of saturated fatty acids, preliminary studies demonstrate that incorporating CSO into a diet 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, 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 or overweight/obesity). There are three diet interventions: CSO (20% energy needs from CSO), matched-PUFA (20% energy needs from non-CSO matched PUFA sources), and Control (20% of energy needs from control oil mixture representative of the average fatty acid composition consumed by U.S. adults). The study protocol consists of a 28-day intervention where participants are provided breakfast shakes that contain a different oil, or mixture of oils, depending on the participant's random group assignment.
There are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 weekly short visits (v2, v3, v4), and post-intervention (v5).
At screening (v0), qualification is confirmed based on anthropometrics and 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.
28-day dietary intervention: Participants will consume a daily shake corresponding to the participant's randomly assigned group. The ingredients for the breakfast shakes are identical between groups, the only difference being the composition of assigned oil provided. The breakfast shakes are portioned based on individual energy needs as estimated at v0.
Participants return weekly (v2, v3, v4), to return study materials and collect shakes for the next week. At these weekly visits, participants also have a fasting blood draw, body measures, and consume the daily breakfast shake in the lab.
At the end of the 28-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 will improve the proposed overall health outcomes and markers of chronic disease risk when compared with the matched PUFA and control groups.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's planned enrollment of 90 is close to 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.
-"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--
Overweight/obesity will be defined by >25 kg/m².
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.
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.
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.
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.
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.
Participants are given a daily shake enriched with cottonseed oil and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Other: COTTONSEED OIL
Participants are given a daily shake enriched with a mixture of oils with a similar fatty acid profile to CSO and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Other: MATCHED PUFA DIET
Participants are given a daily shake enriched with a mixture of oils that match the fatty acid profile of the average American diet, and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Other: CONTROL
Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.
Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs from oils with similar fatty acid composition as CSO for 28 days.
Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.
Change in fasting serum lipoprotein and cholesterol concentrations
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg/dL)
Time frame: baseline, 4 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, 4 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, 4 weeks
Change in fasting serum hepatic enzymes
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L)
Time frame: Baseline, 4 weeks
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL)
Time frame: Baseline, 4 weeks
Change in fasting serum lipoprotein particle numbers
Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L)
Time frame: baseline, 4 weeks
Change in fasting serum bilirubin
Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)
Time frame: Baseline, 4 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, 4 weeks
Change in fasting plasma markers of coagulation potential
The concentration of plasminogen activator inhibitor-1, and tissue factor at fasting for both pre- and post- intervention visits (pg/mL)
Time frame: baseline, 4 weeks
Change in fasting inflammatory cytokine concentrations
The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, interleukin-6, and monocyte chemoattractant protein-1 at fasting at both pre-and post-intervention visits (pg/mL).
Time frame: baseline, 4 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, 4 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, 4 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, 4 weeks
Change in fasting and postprandial plasma appetite control hormones 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), Ghrelin (pg/mL)
Time frame: baseline, 4 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, 4 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, 4 weeks
Change in additional fasting plasma inflammatory cytokine concentrations
The concentration of monocyte chemoattractant protein-1, and interleukin-10, at fasting for both pre- and post-intervention visits (pg/mL)
Time frame: baseline, 4 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, 4 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 28-day intervention.
Time frame: baseline, 4 weeks
Change in blood pressure
Systolic and diastolic blood pressure (mmHg)
Time frame: baseline, 4 weeks
Change in body weight
body weight (kg)
Time frame: baseline, 4 weeks
Change in body composition
DXA will be used to measure body fat percentage (body fat %)
Time frame: baseline, 4 weeks
Change in diet composition
3-day food records will be used to record foods and beverages consumed before and during the 28-day intervention period
Time frame: baseline, week 2, week 4
Desaturation index
Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids)
Time frame: baseline, 4 weeks
Change in fasting tocopherol concentrations
Plasma tocopherol concentrations (ug/mL)
Time frame: baseline, 4 weeks
Change in anthropometric circumferences
hip and waist circumferences (cm)
Time frame: baseline, 4 weeks
Change in 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, 4 weeks
Change in anxiety
The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels
Time frame: baseline, 4 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, 2 weeks, 4 weeks
Change in Body Mass Index (BMI)
BMI will be calculated based on height and weight measures (kg/m²)
Time frame: baseline, 4 weeks
Change in additional fasting plasma markers of coagulation potential
The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen and D-dimer, at fasting for both pre- and post- intervention visits (pg/mL)
Time frame: baseline, 4 weeks
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 months after the start.
Of 194 non-industry interventional studies with no phase under Dyslipidemias, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's planned 28 months is above that.
Counting every sponsor, half of 205 studies reached it within 16 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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