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| Name | Class |
|---|---|
| United States Department of Agriculture (USDA) | FED |
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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:
Participants will be asked to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting serum hepatic enzymes | Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-Glutamyl Transferase (GGT) (U/L) | Baseline, 4 weeks |
| Change in fasting serum hepatic proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) | baseline, 4 weeks |
| Change in body weight | body weight (kg) | baseline, 4 weeks |
Inclusion Criteria:
-"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--
Overweight/obesity will be defined by body mass index >25 kg/m².
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie Cooper, PhD | Contact | 706-542-4378 | jamie.cooper@uga.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jamie Cooper, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Recruiting | Athens | Georgia | 30602 | United States |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D003369 | Cottonseed Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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.
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Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group.
| 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. |
|
| 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. |
|
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 |
Total protein and albumin (g/dL)
| 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) | baseline, 4 weeks |
| Change in fasting serum bilirubin | Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL) | 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) | 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) | 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) | baseline, 4 weeks |
| Change in additional fasting plasma markers of coagulation potential | The concentration of Von Willebrand factor, tissue factor pathway inhibitor, fibrinogen and D-dimer, at fasting for both pre- and post- intervention visits (pg/mL) | 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 | 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. | baseline, 4 weeks |
| Change in body composition | DXA will be used to measure body fat percentage (body fat %) | baseline, 4 weeks |
| 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 | baseline, week 2, week 4 |
| Change in fasting tocopherol concentrations | Plasma tocopherol concentrations (ug/mL) | baseline, 4 weeks |
| Change in anthropometric circumferences | hip and waist circumferences (cm) | baseline, 4 weeks |
| Change in resting metabolic rate | Resting metabolic rate (RMR) will be measured for 30 minutes on the TrueOne 2400 (Parvo Medics, Sandy, UT) | Screening |
| Change in Perceived Stress | Perceived Stress Scale will be administered and scored to determine stress levels | baseline, 4 weeks |
| Change in anxiety | The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels | baseline, 4 weeks |
| Change in self reported physical activity levels | The International Physical Activity Questionnaire will be used to collect self-reported average physical activity levels (met/min) | baseline, 2 weeks, 4 weeks |
| Change in Body Mass Index (BMI) | BMI will be calculated based on height and weight measures (kg/m²) | baseline, 4 weeks |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |