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| Name | Class |
|---|---|
| Cotton Incorporated | UNKNOWN |
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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:
Participants will be asked to:
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.
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 our food supply. Our previous studies have demonstrated that incorporating CSO into the diet is sufficient to reduce fasting total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-c), increase high-density lipoprotein cholesterol (HDL-c), and improve postprandial lipid and/or glycemic responses in both healthy and at-risk populations. However, in these human studies, diets provided 30-44% of total energy from CSO, which corresponded to high-fat (HF) diet intake (40-50% of energy). The impact of lower doses of CSO on human health has yet to be tested. Therefore, this study aims to investigate whether lower doses of CSO are equally effective as previously proven high doses for improving fasting and postprandial lipid metabolism and markers of chronic disease risk. If lower doses of CSO in the diet are found to improve these markers, these study findings could lead to improvements in health.
This prospective clinical study is a single-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles or overweight/obesity). There are four diet interventions: CSO LOW (10% energy from CSO), CSO MID (20% energy from CSO), CSO HIGH (30% energy from CSO), and CON (10% energy from control oil mix). The study protocol consists of a 28-day intervention where participants are provided breakfast shakes and snacks that contain different amounts of cooking oil depending on their 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 BodPod. Next, a certified phlebotomist places an IV catheter and takes the fasting blood sample. Then the participant consumes a high-saturated-fat meal challenge which delivers 35% of their estimated energy needs (from v0). Then the participant has blood drawn 8 times using the IV catheter over the next 5 hours.
28-day dietary intervention: Before leaving v1, participants are sent home with their first week's supply of daily shakes and snacks corresponding to their randomly assigned group. The ingredients for the breakfast shakes and snacks are identical between groups, the only difference being the amount of the assigned oil incorporated into the foods. All foods are portioned based on individual energy needs as estimated at v0.
Participants return weekly (v2, v3, v4) to return study materials and collect food for the next week. At these weekly visits, participants also have a fasting blood draw, body measures and consume their first breakfast shake of the week in the lab.
At the end of the 28-day dietary intervention, participants return for v5, where all procedures from v1 are repeated.
The investigators hypothesize that CSO LOW, CSO MID, and CSO HIGH will improve the proposed overall health outcomes and markers of chronic disease risk without changing inflammatory markers compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSO LOW | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
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| CSO MID | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
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| CSO HIGH | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
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| CONTROL | Active Comparator | Participants are given foods enriched with a mixture of oils and instructed on how to substitute study foods into their diet to maintain caloric balance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSO LOW | Other | Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as cottonseed oil for 28 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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) | 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) | 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) | 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) | baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting serum hepatic enzymes | Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L) | Baseline, 4 weeks |
| Change in fasting serum hepatic proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) | baseline, 4 weeks |
| Change in body weight | body weight (kg) | baseline, 4 weeks |
Inclusion Criteria:
Overweight/obesity will be defined by body mass index (overweight 25-29.9 kg/m2 or obesity 30 kg/m2 or greater).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie A Cooper, Ph.D. | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41238122 | Derived | Hawkins CD, Prater MC, Ward CA, Paton CM, Cooper JA. Dose-Response Effects of Cottonseed Oil on Blood Lipid Responses in Adults at Risk of Cardiovascular Disease: A Randomized Controlled Trial. J Nutr. 2026 Feb;156(2):101236. doi: 10.1016/j.tjnut.2025.11.006. Epub 2025 Nov 12. |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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Four groups of 28-day parallel feeding trials with three groups receiving different amounts of cottonseed oil (low, mid, high) and one group serving as control receiving a mixture of oils that match the fatty acid profile of the average American diet.
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Participants are blinded to which group they are in and what oil they are receiving.
| CSO MID | Other | Participants are provided a breakfast shake and a snack daily that delivers 20% of the participant's estimated energy needs as cottonseed oil for 28 days. |
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| CSO HIGH | Other | Participants are provided a breakfast shake and a snack daily that delivers 30% of the participant's estimated energy needs as cottonseed oil for 28 days. |
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| CONTROL | Other | Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as a mixture of oils that match the average American fat intake for 28 days. |
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| 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) | 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 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). | 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). | 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). | baseline, 4 weeks |
| Change in fasting and postprandial plasma inflammatory cytokine concentrations | The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). | baseline, 4 weeks |
| Change in fasting and postprandial plasma markers of coagulation potential | The concentration of plasminogen activator inhibitor-1, and tissue factor before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). | 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). | baseline, 4 weeks |
| Change in fasting insulin resistance metrics | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and Homeostatic Model Assessment for β-cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention. | baseline, 4 weeks |
Total protein and albumin (g/dL)
| Baseline, 4 weeks |
| Change in fasting serum bilirubin | Total total bilirubin, direct bilirubin, and indirect bilirubin (mg/dL) | Baseline, 4 weeks |
| Change in additional fasting and postprandial plasma appetite control hormones concentrations | The concentration of additional plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Additional appetite control hormones include Glucagon-like peptide-1 (GLP-1), Gastric inhibitory peptide (GIP), Pancreatic Polypeptide (PP) (pg/mL) | baseline, 4 weeks |
| Change in fasting and postprandial plasma antioxidant parameters | Glutathione peroxidase activity, superoxide dismutase activity, glutathione-s-transferase activity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL). | baseline, 4 weeks |
| Change in additional fasting and postprandial plasma inflammatory cytokine concentrations | The concentration of monocyte chemoattractant protein-1, and interleukin-10 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). | baseline, 4 weeks |
| Change in additional fasting and postprandial plasma markers of coagulation potential | The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen and D-dimer before and after the high saturated fat meal challenge at both pre- and post-intervention visits (pg/mL). | 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 | baseline, 4 weeks |
| Change in body composition | BodPod will be used to measure body fat percentage (body fat %) | baseline, 4 weeks |
| Change in diet composition | 3-day food logs will be used to record foods and beverages consumed before and during the 28-day intervention period | baseline, week 2, week 4 |
| Change in fasting and postprandial fatty acid composition | Fatty acid composition of plasma before and after the high saturated fat meal challenge at pre- and post-intervention visits (% total triglycerides). | baseline, 4 weeks |
| Change in fasting tocopherol concentrations | Plasma tocopherol concentrations (ug/ml) | baseline, 4 weeks |
| Change in anthropometric circumferences | hip and waist circumferences (cm) | 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) | Screening |
| Change in perceived stress | Perceived Stress Scale will be administered and scored to determine stress levels | baseline, 4 weeks |
| Change in anxiety | The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels. | 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) | baseline, 2 weeks, 4 weeks |
| Change in body Mass Index (BMI) | BMI will be calculated based on height and weight measures (kg/m2) | baseline, 4 weeks |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |