Cottonseed Oil Versus Matched PUFA Effects

NCT06382298 | Recruiting

• 1 other identifier: PROJECT00009332
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Dyslipidemia; Overweight and Obesity; Nutrition, Healthy

Outcome Measures

Primary Outcomes (11)

• Change in fasting serum lipoprotein and cholesterol concentrations

  The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein B (mg/dL)

  baseline, 4 weeks

• Change in fasting and postprandial plasma triglyceride concentrations

  The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)

  baseline, 4 weeks

• Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations

  The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mEq/L)

  baseline, 4 weeks

• Change in fasting and postprandial plasma appetite control hormones concentrations

  The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), Ghrelin (pg/mL)

  baseline, 4 weeks

• Change in fasting and postprandial subjective feelings related to appetite

  Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post- intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption and a composite appetite score are measured by visual analog scales (mm).

  baseline, 4 weeks

• Change in fasting and postprandial plasma Malondialdehyde (MDA)

  The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post- intervention visits (nmol/mL).

  baseline, 4 weeks

• Change in fasting and postprandial plasma total antioxidant capacity

  Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post- intervention visits (U/mL).

  baseline, 4 weeks

• Change in fasting inflammatory cytokine concentrations

  The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).

  baseline, 4 weeks

• Change in fasting plasma markers of coagulation potential

  The concentration of plasminogen activator inhibitor-1, and tissue factor at fasting for both pre- and post- intervention visits (pg/mL)

  baseline, 4 weeks

• Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins

  The concentration of ANGPTL 3, ANGPTL 4 and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post- intervention visits (ng/mL)

  baseline, 4 weeks

• Desaturation index

  Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids)

  baseline, 4 weeks

Secondary Outcomes (10)

• Change in fasting serum hepatic enzymes

  Baseline, 4 weeks

• Change in fasting serum hepatic proteins

  Baseline, 4 weeks

• Change in fasting serum lipoprotein particle numbers

  baseline, 4 weeks

• Change in fasting serum bilirubin

  Baseline, 4 weeks

• Change in fasting and postprandial plasma insulin concentrations

  baseline, 4 weeks

Other Outcomes (11)

• Change in blood pressure

  baseline, 4 weeks

• Change in body weight

  baseline, 4 weeks

• Change in body composition

  baseline, 4 weeks

Study Arms (3)

COTTONSEED OIL

EXPERIMENTAL

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.

Other: COTTONSEED OIL

MATCHED PUFA DIET

EXPERIMENTAL

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.

Other: MATCHED PUFA DIET

CONTROL

ACTIVE COMPARATOR

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.

Other: CONTROL

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.

COTTONSEED OIL

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.

MATCHED PUFA DIET

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.

CONTROL

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative.
• Women on hormone replacement therapy less than 2 years.
• Women who are pregnant
• individuals who regularly exercise more than 3h/w
• weight gain or loss of more than 5% body weight in the past 3 months
• plans to begin a weight loss/exercise regimen during the trial
• history of medical or surgical events that could affect digestion or swallowing
• gastrointestinal surgeries, conditions, or disorders
• any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease),
• metabolic disease
• atherosclerosis
• previous MI or stroke
• cancer
• fasting blood glucose levels greater than 126 mg/dL
• blood pressure greater than 180/120 mmHg

Sponsors & Collaborators

• University of Georgia: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Overweight; Obesity

Interventions

Cottonseed Oil

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jamie Cooper, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Cooper, PhD

CONTACT

706-542-4378; jamie.cooper@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department Head of Kinesiology, Director of UGA Obesity Initiative

Model Details: Three groups of 28-day parallel feeding trials with two groups receiving 20% of energy needs from CSO, or matched PUFA diet, and one group serving as control receiving 20% of energy needs as a mixture of oils that match the fatty acid profile of the average American intake.

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)