DyslipidemiaNCT07246408
Intermittent Cottonseed Oil Consumption
A study testing CSO-30 and CSO-20 in people with Dyslipidemia and Overweight and Obesity, run by University of Georgia at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Overweight and Obesity, Nutrition, Healthy
- What is being tested?
- CSO-30 and CSO-20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2026to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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 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 less than 2 years.
- 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
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 disease
- 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, absorption, or 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 soy, dairy, gluten, Yellow No. 5, cottonseed oil, palm oil, and coconut oil)
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Georgia
Athens, Georgia, 30602
Jamie A Cooper, PhD, 706-542-4378, jamie.cooper@uga.edu
Jamie A Cooper, PhD
About this study
Official title: Intermittent Cottonseed Oil Consumption on Cardiovascular Disease Risk Reduction
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Dyslipidemia, Overweight and Obesity, Nutrition, Healthy
- Being tested
- CSO-30, CSO-20, 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-30Other
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.
CSO-20Other
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CSO-30 | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. Receives: Other: CSO-30 |
| CSO-20 | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. Receives: Other: CSO-20 |
| Control | Placebo comparator | Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual 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, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)
Measured: 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)
Measured: 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)
Measured: baseline, 8 weeks
Secondary outcomes (15)
Change in fasting serum hepatic enzymes
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L)
Measured: baseline, 8 weeks
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL)
Measured: baseline, 8 weeks
Change in fasting serum bilirubin
Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: baseline, 8 weeks
Desaturation index
Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids)
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start16 Jan 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Three groups of 56-day parallel feeding trials with one group receiving 30% of energy needs from CSO, one group receiving 20% of energy needs from CSO, and one group serving as Control receiving no CSO.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
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 Cooper, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246408
- Sponsor's protocol ID
- PROJECT00013264
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Cottonseed Oil Consumption on Cardiovascular Disease Risk Reduction
- ClinicalTrials.gov ID
- NCT07246408
- Acronym / sponsor ID
- PROJECT00013264
- Conditions
- Dyslipidemia, Overweight and Obesity, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Cotton Incorporated
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 24 Nov 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Three groups of 56-day parallel feeding trials with one group receiving 30% of energy needs from CSO, one group receiving 20% of energy needs from CSO, and one group serving as Control receiving no CSO.
| Arm | Type | Receives |
|---|---|---|
| CSO-30 | Experimental | Other: CSO-30Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. |
| CSO-20 | Experimental | Other: CSO-20Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. |
| Control | Placebo comparator | Other: ControlParticipants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual 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 (4 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 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).
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 less than 2 years.
- 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
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-30Participants 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. | Other | CSO-30 |
| CSO-20Participants 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. | Other | CSO-20 |
| ControlParticipants 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. | Other | Control |
Primary outcome
Change in fasting serum lipoprotein and cholesterol concentrations
Time frame: baseline, 8 weeks
The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)
Change in fasting and postprandial plasma triglyceride concentrations
Time frame: baseline, 8 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, 8 weeks
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)
15 secondary outcomes
Change in fasting serum hepatic enzymes
Time frame: baseline, 8 weeks
Change in fasting serum hepatic proteins
Time frame: baseline, 8 weeks
Change in fasting serum bilirubin
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma insulin concentrations
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Time frame: baseline, 8 weeks
Change in fasting plasma markers of coagulation potential
Time frame: baseline, 8 weeks
Change in fasting inflammatory cytokine concentrations
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma total antioxidant capacity
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Time frame: baseline, 8 weeks
Change in fasting and postprandial subjective feelings related to appetite
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma appetite control hormone concentrations
Time frame: baseline, 8 weeks
Change in fasting and postprandial plasma glucose concentrations
Time frame: baseline, 8 weeks
Change in acute dietary intake
Time frame: baseline, 8 weeks
Change in fasting insulin resistance metrics
Time frame: baseline, 8 weeks
Desaturation index
Time frame: baseline, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
Jamie Cooper, PhD 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-30 and CSO-20 in people with Dyslipidemia 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 4 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: looking for participants now, as of the sponsor's last update on 9 Sep 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Cooper, PhD (706-542-4378, jamie.cooper@uga.edu), or a site near the patient. 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, 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.