Cottonseed Oil Dose Response

Summary

Adding cottonseed oil to the diet has been shown to improve cholesterol profiles and other markers of chronic disease risk in both healthy and at-risk adults. However, CSO has only been tested in the context of high-fat diets. The goal of this clinical trial is to learn about the health effects of lower amounts of cottonseed oil (CSO) added to the diet in adults at increased risk for cardiovascular disease.

The main questions it aims to answer are:

* How do different amounts of CSO in the diet affect fasting cholesterol profiles and markers of liver function?
* How do different amounts of CSO in the diet affect fasting and post-meal markers of lipid metabolism (i.e. triglycerides) and glycemic control (i.e. blood sugar and insulin)?
* How do different amounts of CSO in the diet affect fasting and post-meal markers of chronic disease risk factors such as oxidative stress, inflammation, coagulation potential, and appetite control?

Participants will be asked to:

* Consume provided breakfast shakes and snacks 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 (5.5 h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.

Researchers will compare CSO LOW, CSO MID, CSO HIGH, and Control groups (receiving a mixture of oils) to see if lower doses of CSO in the diet impart the same health benefits as previously shown with high doses of CSO.

Conditions

• Dyslipidemias
• Overweight and Obesity
• Nutrition, Healthy

Interventions

OTHER

CSO LOW

Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as cottonseed oil for 28 days.

OTHER

CSO MID

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

OTHER

CSO HIGH

Participants are provided a breakfast shake and a snack daily that delivers 30% of the participant's estimated energy needs as cottonseed oil for 28 days.

OTHER

CONTROL

Participants are provided a breakfast shake and a snack daily that delivers 10% of the participant's estimated energy needs as a mixture of oils that match the average American fat intake for 28 days.

Sponsors & Collaborators

• Cotton Incorporated

  collaborator UNKNOWN

• University of Georgia

  lead OTHER

Principal Investigators

• Jamie A Cooper, Ph.D. · University of Georgia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2024-05-02

Completion

2024-05-02

Countries

• United States

Study Locations