Clinical Trials Logo

Clinical Trial Summary

More than 31 million U.S. adults have high total cholesterol and over 73 million U.S. adults have high LDL cholesterol. Cottonseed oil (CSO) is found readily in our food supply, and recent research has shown improvements in blood lipids following CSO consumption in healthy adults with normal cholesterol profiles. To date, however, there are no published studies on the effects of CSO-enriched diets on blood lipids and markers of health in an older population with hypercholesterolemia. Therefore, the purpose of this study is to test the health effects of a diet rich in CSO against a diet rich in olive oil to determine if the CSO-enriched diet will show greater improvements in blood lipids and other health markers in adults with high cholesterol levels. If CSO in the diet is found to improve these markers, these study findings could lead to improvements in health.


Clinical Trial Description

This was a single-blind, randomized controlled trial. Investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels). Subjects were randomized into one of two groups: (1) Cottonseed oil (CSO), (2) Olive oil (OO). The interventions consist of identical foods that are only different in the respective oil they are prepared with. There was a screening visit and 3 testing visits: Baseline (visit 2), mid-visit at week 4 (visit 6), and post-visit at week 8 (visit 10). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. At visits 2 and 10 participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected. Visits 3-9 represent weekly meal pickups, with the exception of visit 6 which is also a testing visit. Hypothesis: Investigators hypothesized that enrichment of the diet with CSO would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the OO group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04397055
Study type Interventional
Source University of Georgia
Contact
Status Completed
Phase N/A
Start date May 14, 2018
Completion date June 8, 2021

See also
  Status Clinical Trial Phase
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Recruiting NCT03947866 - Ezetimibe-Rosuvastatin Evaluation Study
Completed NCT01709513 - Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE) Phase 3
Completed NCT01212900 - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression Phase 4
Completed NCT00001154 - Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
Completed NCT02550288 - A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383) Phase 3
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT04485793 - Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia N/A
Completed NCT02341924 - Validating the "Foods for Health" Portfolio of Functional Food Products N/A
Active, not recruiting NCT02223793 - Vascular Lifestyle-Intervention and Screening in Pharmacy N/A
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01941836 - Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients Phase 2
Recruiting NCT01705873 - Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen N/A
Completed NCT01670734 - Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects Phase 1
Completed NCT01678521 - Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients N/A
Completed NCT01370590 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1) Phase 3
Completed NCT01370603 - A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) Phase 3
Completed NCT01768403 - Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia N/A
Completed NCT01446679 - Special Drug Use-Results Survey of Lipitor Tablets N/A
Completed NCT01478789 - Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans N/A