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Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ 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.

⁃ Elevated cholesterol profiles will be defined as:

• Borderline High and/or at risk in two of more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) --or--

⁃ High in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL).

‣ Overweight/obesity will be defined by body mass index \>25 kg/m².

Locations
United States
Georgia
University of Georgia
RECRUITING
Athens
Contact Information
Primary
Jamie Cooper, PhD
jamie.cooper@uga.edu
706-542-4378
Time Frame
Start Date: 2024-08-31
Estimated Completion Date: 2028-05
Participants
Target number of participants: 90
Treatments
Experimental: COTTONSEED OIL
Participants are given a daily shake enriched with cottonseed oil and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Experimental: MATCHED PUFA DIET
Participants are given a daily shake enriched with a mixture of oils with a similar fatty acid profile to CSO and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Active_comparator: CONTROL
Participants are given a daily shake enriched with a mixture of oils that match the fatty acid profile of the average American diet, and instructed on how to substitute provided study shake into usual diet to maintain caloric balance.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Agriculture (USDA)
Leads: University of Georgia

This content was sourced from clinicaltrials.gov

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