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| Name | Class |
|---|---|
| Georgia Pecan Commission | UNKNOWN |
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Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance.
Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for cardiovascular disease.
This was a single-blind, randomized controlled trial. The investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels) or at higher risk for cardiovascular disease (CVD) (BMI > 28 kg/m2). Subjects were randomized into one of three groups: (1) the no nut group (CON), (2) pecan ADD (no diet instructions), and (3) pecan SUB (instructions to substitute pecans with isocaloric foods in habitual diet).
There was a screening visit and 3 testing visits: Baseline (visit 1), mid-visit at week 4 (visit 2), and post-visit at week 8 (visit 3). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. A subset of participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected.
Hypothesis: The investigators hypothesized that daily pecan consumption would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the control group. The investigators also hypothesized that pecan ADD group will result in a larger increase in body weight compared to the pecan SUB and control groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Participants in this group avoid all nuts for 8 weeks. | |
| Pecan ADD | Experimental | Participants in this group consume 68 g of pecans/d with no additional dietary instructions and avoid all other nuts. |
|
| Pecan SUB | Experimental | Participants in this group consume 68 g of pecans/d with instructions to substitute pecans with isocaloric foods in the habitual diet. They are also instructed to avoid all other nuts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pecan ADD | Dietary Supplement | Raw pecan halves without dietary substitution instructions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline fasting blood lipids at 4 weeks and 8 weeks | Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), non-HDL cholesterol (mg/dL), apolipoprotein B (mg/dL) | Baseline, 4 weeks, 8 weeks |
| Change in baseline lipoprotein(a), lipoprotein particle number, and lipoprotein size at 4 and 8 weeks | Low-density lipoprotein (LDL) particle number (nmol/L), LDL small (nmol/L), LDL medium (nmol/L), HDL large (nmol/L), lipoprotein(a) (nmol/L) | Baseline, 4 weeks, 8 weeks |
| Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks | LDL peak size (angstrom) | Baseline, 4 weeks, 8 weeks |
| Change in baseline weight at 4 and 8 weeks | Weight (kg) | Baseline, 4 weeks, 8 weeks |
| Change in baseline waist and hip circumference at 4 and 8 weeks | waist and hip circumference (cm) | Baseline, 4 weeks, 8 weeks |
| Change in baseline total body fat percentage at 4 and 8 weeks | Total body fat percentage (%) | Baseline, 4 weeks, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 8 weeks | Peptide YY (pg/mL), CCK (pg/mL) and ghrelin (pg/mL) | Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks. |
| Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline perceived stress at 4 and 8 weeks | The perceived stress scale (PSS) measures stress over the last 4 weeks on a scale from 0-40. Low scores indicate low stress. A score of 13 is average. Scores of 20 or greater are considered to be high stress. | Baseline, 4 weeks, 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia- Department of Foods and Nutrition | Athens | Georgia | 30605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34383903 | Derived | Guarneiri LL, Paton CM, Cooper JA. Pecan-Enriched Diets Alter Cholesterol Profiles and Triglycerides in Adults at Risk for Cardiovascular Disease in a Randomized, Controlled Trial. J Nutr. 2021 Oct 1;151(10):3091-3101. doi: 10.1093/jn/nxab248. |
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The plan is to share group averages through publication.
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Participants are unaware that there are 2 pecan groups (with and without dietary substitution instructions)
| Pecan SUB | Dietary Supplement | Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet |
|
|
Glucose (mg/dL) and triglycerides (mg/dL) |
| Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks. |
| Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 8 weeks | NEFA (mEq/L) | Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks. |
| Change in fasting and postprandial insulin from baseline to 8 weeks | Insulin (uU/mL) | Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks. |
| Change in resting metabolic rate (RMR) from baseline to 8 weeks | RMR (kcals/d) measured via indirect calorimetry | Baseline and 8 weeks |
| Change in diet induced thermogenesis (DIT) from baseline to 8 weeks | DIT (kcals) measured via indirect calorimetry | Baseline and 8 weeks |
| Change in fasting and postprandial carbohydrate and fat oxidation from baseline to 8 weeks | Carbohydrate oxidation (g) and fat oxidation (g) measured via indirect calorimetry | Measured at fasting and for 3.5h postprandially at baseline and 8 weeks |
| Change in diet respiratory exchange ratio (RER) from baseline to 8 weeks | RER measured via indirect calorimetry | Measured at fasting and for 3.5h postprandially at baseline and 8 weeks |
| Change in fasting and postprandial lipid peroxidation from baseline to 8 weeks | Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay. | Measured at fasting and for 4 hours postprandially at baseline and 8 weeks |
| Change in fasting and postprandial total antioxidant capacity from baseline to 8 weeks | Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay. | Measured at fasting and for 4 hours postprandially at baseline and 8 weeks |
| Changes in fasting and postprandial hunger and satiety from baseline to 8 weeks | Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no hunger, fullness, prospective consumption, and desire to eat, while 100 represents the greatest feeling of these outcomes. | Measured at fasting and for 4 hours postprandially at baseline and 8 weeks. Also, measured once per hour after the baseline and 8-week visits. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |