Cottonseed Oil Versus Matched PUFA Effects

Part of paid clinical trials in Athens, Georgia.

Sponsor
University of Georgia
Study ID
NCT06382298
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • COTTONSEED OIL — OTHER
    Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.
  • MATCHED PUFA DIET — OTHER
    Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs from oils with similar fatty acid composition as CSO for 28 days.
  • CONTROL — OTHER
    Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.

Primary Outcome Measure

Change in fasting serum lipoprotein and cholesterol concentrations [ Time Frame: baseline, 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of GeorgiaAthensGeorgia30602
Jamie A Cooper, Ph.D.
[email protected]
706-542-4378
Jamie A Cooper, Ph.D. (PRINCIPAL_INVESTIGATOR)

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