RECRUITING

Cottonseed Oil Versus Matched PUFA Effects

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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: * Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. * Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: * Consume provided meal replacement shakes 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 (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. 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.

Official Title

Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans

Quick Facts

Study Start:2024-08-31
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06382298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Elevated cholesterol profiles will be defined as:
  3. * "High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL).
  1. * 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.
  2. * Women on hormone replacement therapy less than 2 years.
  3. * Women who are pregnant
  4. * individuals who regularly exercise more than 3h/w
  5. * weight gain or loss of more than 5% body weight in the past 3 months
  6. * plans to begin a weight loss/exercise regimen during the trial
  7. * history of medical or surgical events that could affect digestion or swallowing
  8. * gastrointestinal surgeries, conditions, or disorders
  9. * any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease),
  10. * metabolic disease
  11. * atherosclerosis
  12. * previous MI or stroke
  13. * cancer
  14. * fasting blood glucose levels greater than 126 mg/dL
  15. * blood pressure greater than 180/120 mmHg
  16. * medication use affecting digestion an absorption, metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
  17. * medically prescribed or special diets
  18. * Food allergies (specific to the foods in the study, including wheat, dairy, and cottonseed oil)
  19. * fish oil supplements
  20. * excessive alcohol use (greater than 3 drinks/day for men; greater than 2 drinks/day for women)
  21. * tobacco or nicotine use
  22. * underweight BMI (\<18.5 kg/m²)

Contacts and Locations

Study Contact

Jamie Cooper, PhD
CONTACT
706-542-4378
jamie.cooper@uga.edu

Principal Investigator

Jamie Cooper, PhD
PRINCIPAL_INVESTIGATOR
University of Georgia

Study Locations (Sites)

University of Georgia
Athens, Georgia, 30602
United States

Collaborators and Investigators

Sponsor: University of Georgia

  • Jamie Cooper, PhD, PRINCIPAL_INVESTIGATOR, University of Georgia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-31
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-08-31
Study Completion Date2028-05

Terms related to this study

Additional Relevant MeSH Terms

  • Dyslipidemia
  • Overweight and Obesity
  • Nutrition, Healthy