NCT06382298

Cottonseed Oil Versus Matched PUFA Effects

Health Effects of Cottonseed Oil Versus Matched Composition Diets in Humans

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Georgia · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Accounting for nearly 1 in every 4 deaths in the U.S., cardiovascular disease (CVD) is the leading cause of death for adults. One risk factor for CVD is hypercholesterolemia which can double the risk for this disease. Cottonseed oil is a rich source of poly-unsaturated fatty acids (PUFAs). Despite having a relatively high amount of saturated fatty acids, preliminary studies demonstrate that incorporating CSO into a diet is sufficient to reduce blood lipid profiles and select postprandial measures of metabolism. These improvements in lipid metabolism may be due to the general fatty acid (FA) composition of CSO; however, evidence shows that a fatty acid unique to CSO, dihydrosterculic acid (DHSA), may be responsible for some, if not all, the positive lipid lowering effects. This prospective clinical study is a double-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles or overweight/obesity). There are three diet interventions: CSO (20% energy needs from CSO), matched-PUFA (20% energy needs from non-CSO matched PUFA sources), and Control (20% of energy needs from control oil mixture representative of the average fatty acid composition consumed by U.S. adults). The study protocol consists of a 28-day intervention where participants are provided breakfast shakes that contain a different oil, or mixture of oils, depending on the participant's random group assignment. There are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 weekly short visits (v2, v3, v4), and post-intervention (v5). At screening (v0), qualification is confirmed based on anthropometrics and fasting blood draw, which is analyzed for a cholesterol panel and blood glucose. Additionally, energy requirements are estimated at this visit for use in the diet intervention. At v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA). Fasting and postprandial blood draws for a 5h period will occur following a high saturated-fat meal challenge which delivers 35% of the participant's estimated energy needs. 28-day dietary intervention: Participants will consume a daily shake corresponding to the participant's randomly assigned group. The ingredients for the breakfast shakes are identical between groups, the only difference being the composition of assigned oil provided. The breakfast shakes are portioned based on individual energy needs as estimated at v0. Participants return weekly (v2, v3, v4), to return study materials and collect shakes for the next week. At these weekly visits, participants also have a fasting blood draw, body measures, and consume the daily breakfast shake in the lab. At the end of the 28-day dietary intervention, participants return for v5, where all procedures from v1 are repeated. As decided a priori, we will complete a per protocol analysis. The investigators hypothesize that CSO will improve the proposed overall health outcomes and markers of chronic disease risk when compared with the matched PUFA and control groups.

Conditions

• Dyslipidemia
• Overweight and Obesity
• Nutrition, Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-12-01
• Completion: 2028-05-01
• First posted: 2024-04-24
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States