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| Name | Class |
|---|---|
| Cotton Incorporated | UNKNOWN |
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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 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.
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 polyunsaturated fatty acids (PUFAs). Despite having a relatively high amount of saturated fatty acids, preliminary studies demonstrate that incorporating CSO into a diet at 30% and 20% of daily energy needs 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, of 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 and/or overweight/obesity). There are three diet interventions: CSO-30 (30% of energy needs from CSO), CSO-20 (20% of energy needs from CSO), and Control (not receiving CSO; will receive thickened water with yellow food coloring to mimic the appearance of oil). The study protocol consists of a 56-day intervention where participants are provided breakfast shakes and snacks that contain different amounts of oil, depending on the participant's random group assignment.
There are a total of 6 testing visits: screening (v0), pre-intervention (v1), 3 bi-weekly (every other week) short visits (v2, v3, v4), and post-intervention (v5).
At screening (v0), qualification is confirmed based on anthropometrics and a 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.
56-day dietary intervention: Participants will consume a shake and snack 3 times per week, corresponding to the participant's randomly assigned group. The ingredients for the breakfast shakes and snacks are identical between groups, the only difference being the amount of assigned oil provided. The breakfast shakes and snacks are portioned based on individual energy needs as estimated at v0.
Participants return every other week (v2, v3, v4), to return study materials and collect shakes and snacks for the next two weeks. At these bi-weekly visits, participants also have a fasting blood draw and body measures taken.
At the end of the 56-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-30 and CSO-20 will improve the proposed overall health outcomes and markers of chronic disease risk without changing inflammatory markers or coagulation potential compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSO-30 | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. |
|
| CSO-20 | Experimental | Participants are given foods enriched with cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. |
|
| Control | Placebo Comparator | Participants are given foods void of cottonseed oil and instructed on how to substitute provided study foods into usual diet to maintain caloric balance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSO-30 | Other | 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. |
| 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, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL) | 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) | 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) | baseline, 8 weeks |
| Change in fasting and postprandial plasma appetite control hormone 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), and Ghrelin (pg/mL) | baseline, 8 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, 8 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) (U/L) | baseline, 8 weeks |
| Change in fasting serum hepatic proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) | baseline, 8 weeks |
| Change in body weight | body weight (kg) | baseline, 8 weeks |
Inclusion Criteria:
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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Three groups of 56-day parallel feeding trials with one group receiving 30% of energy needs from CSO, one group receiving 20% of energy needs from CSO, and one group serving as Control receiving no CSO.
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Participants are blinded to their group assignment. Investigator blinded to participant's intervention group assignment.
| CSO-20 | Other | 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 | 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. |
|
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL). |
| baseline, 8 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, 8 weeks |
| Change in fasting inflammatory cytokine concentrations | The concentration of interleukin-1 beta, C-reactive protein, tumor-necrosis factor-alpha, interleukin-10, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL). | baseline, 8 weeks |
| Change in fasting plasma markers of coagulation potential | The concentration of plasminogen activator inhibitor-1, fibrinogen, and tissue factor at fasting for both pre- and post-intervention visits (pg/mL) | baseline, 8 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, 8 weeks |
Total protein and albumin (g/dL)
| baseline, 8 weeks |
| Change in fasting serum bilirubin | Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL) | 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) | baseline, 8 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, 8 weeks |
| Change in additional fasting plasma markers of coagulation potential | The concentration of Von Willebrand factor, tissue factor pathway inhibitor, and D-dimer at fasting for both pre- and post-intervention visits (pg/mL) | baseline, 8 weeks |
| Change in acute dietary intake | One-day food logs will be used to record all foods and beverages consumed on testing days | baseline, 8 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 56-day intervention. | baseline, 8 weeks |
| Desaturation index | Measurement of fatty acid concentrations for fasting and post-prandial plasma (ratio of unsaturated to saturated fatty acids) | baseline, 8 weeks |
| Change in body composition | DXA will be used to measure body fat percentage (body fat %) | 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 | baseline, week 4, week 8 |
| Change in fasting tocopherol concentrations | Plasma tocopherol concentrations (ug/mL) | baseline, 8 weeks |
| Change in anthropometric circumferences | hip and waist circumferences (cm) | baseline, 8 weeks |
| 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, 8 weeks |
| Change in anxiety | The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels | baseline, 8 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, week 4, week 8 |
| Change in Body Mass Index (BMI) | BMI will be calculated based on height and weight measures (kg/m²) | baseline, 8 weeks |
| Change in highly processed food (HPF) consumption | The Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF) will be administered and scored to determine HPF consumption | baseline, 8 weeks |
| Change in pro-inflammatory and anti-inflammatory food consumption | The Anti-Inflammatory Diet Index-20 (AIDI-20) Inspired Questionnaire will be administered and scored to determine pro-inflammatory and anti-inflammatory food consumption | baseline, 8 weeks |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |