Health TrialsbyHealthPanel

Cottonseed Oil Versus Matched PUFA Effects

ConditionsDyslipidemiaOverweight and ObesityNutrition, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity of Georgia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

25-75 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.

"High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • COTTONSEED OIL

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: COTTONSEED OILExperimental treatment 1 intervention
Group B: MATCHED PUFA DIETExperimental treatment 1 intervention
Group C: CONTROLActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
baseline, 4 weeks
2

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)

Time frame
baseline, 4 weeks
3

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)

Time frame
baseline, 4 weeks

Secondary outcomes

1

Change in fasting serum hepatic enzymes

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L)

Time frame
Baseline, 4 weeks
2

Change in fasting serum hepatic proteins

Total protein and albumin (g/dL)

Time frame
Baseline, 4 weeks
3

Change in fasting serum lipoprotein particle numbers

Number of particles of low density lipoproteins (LDL), LDL small, HDL large, LDL medium, lipoprotein (a) (nmol/L)

Time frame
baseline, 4 weeks
4

Change in fasting serum bilirubin

Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)

Time frame
Baseline, 4 weeks

Other outcomes

1

Change in blood pressure

Systolic and diastolic blood pressure (mmHg)

Time frame
baseline, 4 weeks
2

Change in body weight

body weight (kg)

Time frame
baseline, 4 weeks
3

Change in body composition

DXA will be used to measure body fat percentage (body fat %)

Time frame
baseline, 4 weeks
4

Change in diet composition

3-day food records will be used to record foods and beverages consumed before and during the 28-day intervention period

Time frame
baseline, week 2, week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Georgia

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator

Source ClinicalTrials.gov
Apply now