DyslipidemiasNCT05686954
Cottonseed Oil Dose Response
A study testing CSO LOW, CSO MID and CSO HIGH in people with Dyslipidemias and Overweight and Obesity, run by University of Georgia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- What is being tested?
- CSO LOW, CSO MID and CSO HIGH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
- women on hormone replacement therapy for less than 2 years
- 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
Show all 22Show fewer
- 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
- atherosclerosis
- previous MI or stroke
- cancer
- fasting blood glucose levels greater than 126 mg/dL
- blood pressure greater than 180/120 mmHg
- medication use affecting digestion and absorption, metabolism (e.g., thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
- medically prescribed or special diets
- Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil)
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Effects of Different Doses of Cottonseed Oil in Humans
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- Being tested
- CSO LOW, CSO MID, CSO HIGH, CONTROL
- Medical subject headings
- Dyslipidemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSO LOWOther
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.
CSO MIDOther
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.
CSO HIGHOther
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.
CONTROLOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CSO LOW |
| 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. Receives: Other: CSO MID |
| 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. Receives: Other: CSO HIGH |
| 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. Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline, 4 weeks
Secondary outcomes (8)
Change in fasting serum hepatic enzymes
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L)
Measured: Baseline, 4 weeks
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL)
Measured: Baseline, 4 weeks
Change in fasting serum bilirubin
Total total bilirubin, direct bilirubin, and indirect bilirubin (mg/dL)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Mar 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Cotton Incorporated
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
- Investigators
- Jamie A Cooper, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686954
- Sponsor's protocol ID
- PROJECT00006633
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2023
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41238122
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Effects of Different Doses of Cottonseed Oil in Humans
- ClinicalTrials.gov ID
- NCT05686954
- Acronym / sponsor ID
- PROJECT00006633
- Conditions
- Dyslipidemias, Overweight and Obesity, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Cotton Incorporated
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CSO LOW | Experimental | Other: CSO LOWParticipants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| CSO MID | Experimental | Other: CSO MIDParticipants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| CSO HIGH | Experimental | Other: CSO HIGHParticipants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance. |
| CONTROL | Active comparator | Other: CONTROLParticipants are given foods enriched with a mixture of oils and instructed on how to substitute study foods into their diet to maintain caloric balance. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
- women on hormone replacement therapy for less than 2 years
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSO LOWParticipants 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. | Other | CSO LOW |
| CSO MIDParticipants 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. | Other | CSO MID |
| CSO HIGHParticipants 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. | Other | CSO HIGH |
| CONTROLParticipants 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. | Other | CONTROL |
Primary outcome
Change in fasting serum lipoprotein and cholesterol concentrations
Time frame: baseline, 4 weeks
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg/dl)
Change in fasting serum lipoprotein particle numbers
Time frame: baseline, 4 weeks
Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L)
Change in fasting and postprandial plasma triglyceride concentrations
Time frame: baseline, 4 weeks
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mg/dL)
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations
Time frame: baseline, 4 weeks
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)
Change in fasting and postprandial plasma glucose concentrations
Time frame: baseline, 4 weeks
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mg/dL)
Change in fasting and postprandial plasma insulin concentrations
Time frame: baseline, 4 weeks
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post-intervention visits (uU/mL)
Change in fasting and postprandial plasma appetite control hormones concentrations
Time frame: baseline, 4 weeks
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)
Change in fasting and postprandial subjective feelings related to appetite
Time frame: baseline, 4 weeks
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).
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Time frame: baseline, 4 weeks
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).
Change in fasting and postprandial plasma total antioxidant capacity
Time frame: baseline, 4 weeks
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).
Change in fasting and postprandial plasma inflammatory cytokine concentrations
Time frame: baseline, 4 weeks
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).
Change in fasting and postprandial plasma markers of coagulation potential
Time frame: baseline, 4 weeks
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).
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Time frame: baseline, 4 weeks
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).
Change in fasting insulin resistance metrics
Time frame: baseline, 4 weeks
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.
8 secondary outcomes
Change in fasting serum hepatic enzymes
Time frame: Baseline, 4 weeks
Change in fasting serum hepatic proteins
Time frame: Baseline, 4 weeks
Change in fasting serum bilirubin
Time frame: Baseline, 4 weeks
Change in additional fasting and postprandial plasma appetite control hormones concentrations
Time frame: baseline, 4 weeks
Change in fasting and postprandial plasma antioxidant parameters
Time frame: baseline, 4 weeks
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations
Time frame: baseline, 4 weeks
Change in additional fasting and postprandial plasma markers of coagulation potential
Time frame: baseline, 4 weeks
Change in acute dietary intake
Time frame: baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 41238122Hawkins 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.
Related trials for Dyslipidemias
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingPhase 2
A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
Severe Hypertriglyceridemia
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie A Cooper, Ph.D. principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSO LOW, CSO MID and CSO HIGH in people with Dyslipidemias and Overweight and Obesity, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting serum lipoprotein and cholesterol concentrations (time frame: baseline, 4 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05686954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.