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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. The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. This study aims to examine the impact of a low dose of pecans on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk.
The specific aims of this study are to:
Participants will be asked to:
Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.
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. Research investigating the relationship between pecan nut consumption and cardiometabolic outcomes has shown that pecan nut consumption can significantly benefit fasting and postprandial blood lipids, reduce CVD risk factors, promote weight maintenance, improve subjective and psychological markers of physiological appetite, increase total antioxidant capacity, and increase energy expenditure and fat oxidation. However, the current literature on pecan consumption and health outcomes only encompasses physiological benefits coming from a dosage of ~ 45g/day and above, which is above the current dietary guidelines. Recent evidence from our pecan dose-response study showed that consuming 6% of energy needs from pecans (~ 21.5 g/day) trended toward reductions in blood lipids but did not reach significance by the end of the short, 4-week intervention. Based on previous interventions with low doses of tree nuts, a longer duration, such as 12 weeks, may be needed to see significant effects. If lower doses of pecans in the diet are found to improve fasting and postprandial lipid metabolism and markers of chronic disease risk, these study findings could lead to improvements in health and possibly provide additional information about dietary guidelines for nut consumption.
This prospective clinical study is a single-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles and/or overweight/obesity). There are two diet interventions: Pecan (6% of energy needs from pecans) and Control (instructed to maintain their current habitual diet, but abstain from any tree nut/peanut consumption and limit nut butters to no more than 2x/wk during the intervention). The study protocol consists of a 12-week intervention that will involve substituting pecans for commonly consumed snack or meal items every day for the entire 12-week intervention or maintaining a current/usual diet.
There are a total of 5 testing visits: screening (v0), pre-intervention (v1), 2 short visits at 4 and 8 weeks (v2, v3), and post-intervention (v4).
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 4h period will occur following a high saturated-fat meal challenge which delivers 17% of the participant's estimated energy needs.
12-week dietary intervention: The 12-week diet intervention will consist of research personnel providing pecans that deliver 6% of the participant's daily energy needs (determined at V0). Participants randomized in the pecan group will receive dietary counseling at the baseline (V1) and intervention visits at 4 and 8 weeks (V2-V3) on substituting pecans for isocaloric foods from their habitual diet. Individuals randomized in the control group will be instructed to follow their habitual diet, but avoid any tree nut/peanut consumption and limit nut butter to no more than 2x/wk, and will not be provided with any food items.
Participants return at 4 and 8 weeks (v2, v3) to return study materials and collect pecans for the next four weeks (if applicable). At these mid-intervention visits, participants also have a fasting blood draw and body measures taken.
At the end of the 12-week dietary intervention, participants return for v4, where all procedures from v1 are repeated.
As decided a priori, we will complete a per protocol analysis. The investigators hypothesize that including the daily consumption of pecans will improve the proposed overall health outcomes and markers of chronic disease risk compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecan | Experimental | Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance. |
|
| Control | Experimental | Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption and limit nut butters to no more than twice per week for the entire 12-week intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecan | Other | Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks. |
|
| 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, oxidized low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL) | baseline, 12 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, 12 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, 12 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, 12 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, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting serum hepatic enzymes | Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L) | baseline, 12 weeks |
| Change in fasting serum hepatic proteins |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Systolic and diastolic blood pressure (mmHg) | baseline, 12 weeks |
| Change in body weight | body weight (kg) | baseline, 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jamie A Cooper, PhD | Contact | 706-542-4378 | jamie.cooper@uga.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jamie A Cooper, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | 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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Two groups of 12-week parallel feeding trials, with one group receiving 6% of energy needs from pecans and one group serving as Control (instructed to maintain their current habitual diet).
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Participants are blinded from which group they are in.
| Control | Other | Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption and limit nut butters to no more than twice per week for the entire 12-week intervention period. |
|
| Change in acute dietary intake |
One-day food logs will be used to record all foods and beverages consumed on testing days |
| baseline, 12 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). | baseline, 12 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, 12 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, 12 weeks |
Total protein and albumin (g/dL)
| baseline, 12 weeks |
| Change in fasting serum bilirubin | Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL) | baseline, 12 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, 12 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, 12 weeks |
| Change in fasting inflammatory cytokine concentrations | The concentration of glycoprotein acetylation (GlycA), 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, 12 weeks |
| Change in fasting plasma markers of coagulation potential | The concentration of plasminogen activator inhibitor-1, fibrinogen, tissue factor, Von Willebrand factor, tissue factor pathway inhibitor, and D-dimer at fasting for both pre- and post-intervention visits (pg/mL) | baseline, 12 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 12-week intervention. | baseline, 12 weeks |
| Change in overall liking and desire to consume subjective ratings of the intervention food provided | Visual analog scale ratings of feelings related to overall liking and desire to consume the intervention food are measured by visual analog scales (mm). | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12 |
| Change in body composition | DXA will be used to measure body fat percentage (body fat %) | baseline, 12 weeks |
| Change in diet composition | 3-day food records will be used to record foods and beverages consumed before and during the 12-week intervention period | baseline, week 4, week 8 |
| Change in fasting tocopherol concentrations | Plasma tocopherol concentrations (ug/mL) | baseline, 12 weeks |
| Change in fasting urolithin concentrations | Plasma urolithin concentrations (ng/mL). | baseline, 12 weeks |
| Change in anthropometric circumferences | hip and waist circumferences (cm) | baseline, 12 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, 12 weeks |
| Change in anxiety | The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels | baseline, 12 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, 12 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, 12 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, 12 weeks |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |