Cottonseed Oil Versus Matched PUFA Effects

NCT06382298 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

Interventions

OTHER

COTTONSEED OIL

Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.

OTHER

MATCHED PUFA DIET

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.

OTHER

CONTROL

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.

Sponsors & Collaborators

  • United States Department of Agriculture (USDA)

    collaborator FED
  • University of Georgia

    lead OTHER

Principal Investigators

  • Jamie Cooper, PhD · University of Georgia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2026-12-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06382298 on ClinicalTrials.gov