Intermittent Cottonseed Oil Consumption

ConditionsDyslipidemia Overweight and Obesity Nutrition, 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 and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x/wk)) on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk.

The specific aims are: \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on fasting and postprandial lipids. \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on other markers of chronic disease risk.

Participants will be asked to:

\*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. \*Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' 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-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.

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.

"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).

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 or nursing/breastfeeding

individuals who regularly exercise more than 3h/w

Trial design

Design model

Parallel

Treatments tested in this trial

CSO-30
Other intervention
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 30% of participant's daily estimated energy needs as cottonseed oil for 56 days.
CSO-20
Other intervention
Participants are provided a breakfast shake and snack to consume 3 times per week that meets 20% of participant's daily estimated energy needs as cottonseed oil for 56 days.
Control
Other intervention
Participants are provided a breakfast shake and snack to consume 3 times per week that does not contain cottonseed oil, but does contain thickened water for blinding purposes, for 56 days.

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: CSO-30Experimental treatment 1 intervention

Group B: CSO-20Experimental treatment 1 intervention

Group C: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in fasting serum lipoprotein and cholesterol concentrations

The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)

Time frame

baseline, 8 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)

Time frame

baseline, 8 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)

Time frame

baseline, 8 weeks

Secondary outcomes

Change in fasting serum hepatic enzymes

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L)

Time frame

baseline, 8 weeks

Change in fasting serum hepatic proteins

Total protein and albumin (g/dL)

Time frame

baseline, 8 weeks

Change in fasting serum bilirubin

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

Time frame

baseline, 8 weeks

Change in fasting and postprandial plasma insulin concentrations

The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post- intervention visits (uU/mL)

Time frame

baseline, 8 weeks

Other outcomes

Change in blood pressure

Systolic and diastolic blood pressure (mmHg)

Time frame

baseline, 8 weeks

Change in body weight

body weight (kg)

Time frame

baseline, 8 weeks

Change in body composition

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

Time frame

baseline, 8 weeks

Change in diet composition

3-day food records will be used to record foods and beverages consumed before and during the 56-day intervention period

Time frame

baseline, week 4, week 8

Sponsors and contacts

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

University of Georgia

Lead sponsor

Cotton Incorporated

Collaborator

Source ClinicalTrials.gov

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