RECRUITING

Cottonseed Oil Dose Response

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

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.

Official Title

Nutritional Effects of Different Doses of Cottonseed Oil in Humans

Quick Facts

Study Start:2023-03-01
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05686954

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. * "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---
  4. * "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 for less than 2 years
  3. * women who are pregnant
  4. * individuals who regularly exercise more than 3 h/w
  5. * weight gain or loss of more than 5% of their 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 diseases
  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 and 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/d for men; greater than 2 drinks/d for women)
  21. * tobacco or nicotine use
  22. * underweight BMI (\<18.5 kg/m2)

Contacts and Locations

Study Contact

Jamie A Cooper, Ph.D.
CONTACT
706-542-4903
jamie.cooper@uga.edu

Principal Investigator

Jamie A Cooper, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Georgia

Study Locations (Sites)

University of Georgia
Athens, Georgia, 30602
United States

Collaborators and Investigators

Sponsor: University of Georgia

  • Jamie A Cooper, Ph.D., 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 Date2023-03-01
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Dyslipidemias
  • Overweight and Obesity
  • Nutrition, Healthy