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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
90
Participants are provided a breakfast shake that meets 20% of participant's daily estimated energy needs as cottonseed oil for 28 days.
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.
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.
University of Georgia
Athens, Georgia, United States
RECRUITINGChange 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
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
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
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
Change in fasting serum hepatic proteins
Total protein and albumin (g/dL)
Time frame: Baseline, 4 weeks
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
Change in fasting serum bilirubin
Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)
Time frame: 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)
Time frame: 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)
Time frame: baseline, 4 weeks
Change in fasting inflammatory cytokine concentrations
The concentration of interleukin-1 beta, C reactive protein, tumor-necrosis factor-alpha, interleukin-6, and monocyte chemoattractant protein-1 at fasting at both pre-and post-intervention visits (pg/mL).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: baseline, 4 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, 4 weeks
Change in fasting and postprandial plasma glucose concentrations
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg/dL)
Time frame: Baseline, 4 weeks
Change in additional fasting plasma inflammatory cytokine concentrations
The concentration of monocyte chemoattractant protein-1, and interleukin-10, at fasting for both pre- and post-intervention visits (pg/mL)
Time frame: baseline, 4 weeks
Change in acute dietary intake
One-day food logs will be used to record all foods and beverages consumed on testing days
Time frame: baseline, 4 weeks
Change in fasting insulin resistance metrics
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and homeostatic model assessment for beta cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 28-day intervention.
Time frame: baseline, 4 weeks
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