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Cottonseed Oil for Dyslipidemia
N/A
Recruiting
Led By Jamie A Cooper, Ph.D.
Research Sponsored by University of Georgia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Overweight/obesity will be defined by body mass index (overweight 25-29.9 kg/m2 or obesity 30 kg/m2 or greater).
25-75-year-old men and women at increased risk for cardiovascular disease defined by elevated cholesterol profiles or overweight/obesity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2, week 4
Awards & highlights
Study Summary
This trial seeks to learn if lower amounts of cottonseed oil in the diet can improve cholesterol profiles & markers of chronic disease risk in adults at risk for CVD. Participants will eat provided meals and snacks for 28 days & attend 3-5.5 hr visits for fasting blood draws & body measurements.
Who is the study for?
Adults aged 25-75 with an increased risk for cardiovascular disease, defined by either high cholesterol levels or being overweight/obese (BMI of 25 kg/m2 or higher), can join this trial. Exclusions include those with digestion issues, heavy alcohol use, metabolic diseases, excessive exercise habits, recent weight fluctuations, and certain medical conditions like uncontrolled blood pressure.Check my eligibility
What is being tested?
The study is testing the effects of different doses of cottonseed oil (CSO) on cholesterol profiles and other health markers related to heart disease risk. Participants will consume CSO at low, medium or high amounts or a control oil blend in their diet for 28 days while undergoing regular health checks.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include changes in digestion due to dietary oil intake and possible allergic reactions to components within the shakes and snacks consumed during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI indicates I am overweight or obese.
Select...
I am between 25-75 years old and at risk for heart disease due to high cholesterol or being overweight.
Select...
My cholesterol levels are either borderline high or high in two or more categories.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Change in fasting and postprandial plasma appetite control hormones concentrations
+11 moreSecondary outcome measures
Change in acute dietary intake
Change in additional fasting and postprandial plasma appetite control hormones concentrations
Change in additional fasting and postprandial plasma inflammatory cytokine concentrations
+5 moreOther outcome measures
Change in anthropometric circumferences
Change in anxiety
Change in blood pressure
+9 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: CSO MIDExperimental Treatment1 Intervention
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group II: CSO LOWExperimental Treatment1 Intervention
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group III: CSO HIGHExperimental Treatment1 Intervention
Participants are given foods enriched with cottonseed oil and instructed on how to substitute study foods into their diet to maintain caloric balance.
Group IV: CONTROLActive Control1 Intervention
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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Who is running the clinical trial?
University of GeorgiaLead Sponsor
100 Previous Clinical Trials
34,578 Total Patients Enrolled
8 Trials studying Obesity
1,209 Patients Enrolled for Obesity
Cotton IncorporatedUNKNOWN
2 Previous Clinical Trials
164 Total Patients Enrolled
Jamie A Cooper, Ph.D.Principal InvestigatorUniversity of Georgia
2 Previous Clinical Trials
125 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have very high cholesterol and a family history of early heart attacks.I have had a heart attack or stroke before.You have a body mass index (BMI) less than 18.5.You use tobacco or nicotine products.You are planning to start a weight loss or exercise program during the trial.My BMI indicates I am overweight or obese.I am not on medications that affect digestion, metabolism, lower lipids, treat diabetes, or are steroids/hormones.I have been diagnosed with atherosclerosis.I am between 25-75 years old and at risk for heart disease due to high cholesterol or being overweight.You are considered overweight or obese based on your body mass index (BMI).I am between 25-75 years old and at high risk for heart disease due to high cholesterol or being overweight.My cholesterol levels are either borderline high or high in two or more categories.I have a history of issues that could affect my ability to digest or swallow.You drink more than 3 drinks a day if you're a man, or more than 2 drinks a day if you're a woman.I have a metabolic disease.Taking fish oil supplements.You exercise for more than 3 hours per week on a regular basis.You have gained or lost more than 5% of your body weight in the past 3 months.I have had surgery or have conditions related to my digestive system.I have a chronic disease like asthma, lung, or kidney disease.Your blood pressure is higher than 180 over 120.Your blood sugar level when you haven't eaten is higher than 126 mg/dL.You are allergic to certain foods like wheat, dairy, or cottonseed oil.I have been on hormone replacement therapy for less than 2 years.You are following a special diet prescribed by a doctor.I have cancer.
Research Study Groups:
This trial has the following groups:- Group 1: CONTROL
- Group 2: CSO LOW
- Group 3: CSO HIGH
- Group 4: CSO MID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this study open to individuals aged sixty and above?
"To comply with the trial's requirements, prospective participants must be aged 25-75."
Answered by AI
Is it possible to register for participation in this clinical experiment?
"This trial is looking for 80 individuals between the ages of 25 and 75 that have dyslipidemia. Those interested should meet these criteria to qualify."
Answered by AI
Are there open positions for participants in this experiment?
"According to the clinicaltrials.gov post, this trial is ongoing and recruiting participants. The initial posting was on January 1st 2023, with the most recent update occurring 13 days later."
Answered by AI
How many research participants are being observed in this clinical experiment?
"That is accurate. As per the information listed on clinicaltrials.gov, this medical trial was first made available for public view on January 1st 2023 and has been actively searching for participants since then; with a total of 80 volunteers needed from just one centre."
Answered by AI
What is the ultimate aim of this experiment?
"The main aim of this trial, that is to be measured at baseline and 4 weeks in, is the alteration in lipoprotein particles found within fasting serum. Secondary objectives include a fluctuation in total protein & albumin (g/dL), an oscillation in direct & indirect bilirubin (mg/dL) levels observed through fasting serum hepatic proteins, as well as any alterations detected with monocyte chemoattractant protein-1 and interleukin-10 concentrations before and after high saturated fat meal challenge both pre-and post-intervention visits (pg/mL)."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
University of Georgia
What portion of applicants met pre-screening criteria?
Met criteria
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