Status:
COMPLETED
Oil Consumption and Cholesterol
Lead Sponsor:
University of Georgia
Collaborating Sponsors:
National Cottonseed Products Association
Cotton Incorporated
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief 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 ha...
Detailed 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) C...
Eligibility Criteria
Inclusion
- 30-75 year old
- body mass index (BMI) between 18.5-39.9 kg/m2
- higher cholesterol levels indicated by "At Risk/Borderline High" in two or more of the variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher), and having triglyceride levels less than 350mg/dL.
Exclusion
- participants with familial hypercholesterolemia
- LDL levels greater than the 95th percentile based on age and sex
- HDL levels lower than the 20th percentile based on age and sex
- women on hormone replacement therapy for less than 2 years
- individuals who regularly exercise more than 3 h/w
- weight gain or loss more than 5% of their body weight in the past 3 months
- plans to begin a weight loss/exercise regiment during the trial
- history of medical or surgical events that could affect digestion or swallowing
- gastrointestinal surgeries
- conditions or disorders
- any chronic or metabolic diseases
- 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 and absorption
- medication use affecting metabolism (e.g. thyroid meds)
- lipid-lowering medications
- medications for diabetes
- steroid/hormone therapies
- a medically prescribed or special diet
- food allergies (specific for the foods made in the study)
- taking fish oil and calciumfloroboron supplements
- excessive alcohol use (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- tobacco or nicotine use
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04397055
Start Date
May 14 2018
End Date
June 8 2021
Last Update
May 10 2023
Active Locations (1)
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1
University of Georgia
Athens, Georgia, United States, 30605