University of Georgia- Department of Foods and Nutrition
Athens, Georgia, 30605, United States
NCT Number: NCT04376632
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.
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Notify Me30 year–75 year
All sexes
Interventional
Not applicable
Athens, Georgia, 30605, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Raw pecan halves without dietary substitution instructions
Other names: Pecan
Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet
Other names: Pecan
Time frame: Baseline, 4 weeks, 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)
Time frame: Baseline, 4 weeks, 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)
Time frame: Baseline, 4 weeks, 8 weeks
LDL peak size (angstrom)
Time frame: Baseline, 4 weeks, 8 weeks
Weight (kg)
Time frame: Baseline, 4 weeks, 8 weeks
waist and hip circumference (cm)
Time frame: Baseline, 4 weeks, 8 weeks
Total body fat percentage (%)
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Peptide YY (pg/mL), CCK (pg/mL) and ghrelin (pg/mL)
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Glucose (mg/dL) and triglycerides (mg/dL)
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
NEFA (mEq/L)
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Insulin (uU/mL)
Time frame: Baseline and 8 weeks
RMR (kcals/d) measured via indirect calorimetry
Time frame: Baseline and 8 weeks
DIT (kcals) measured via indirect calorimetry
Time frame: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Carbohydrate oxidation (g) and fat oxidation (g) measured via indirect calorimetry
Time frame: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
RER measured via indirect calorimetry
Time frame: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Time frame: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Time frame: 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.
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.
Time frame: Baseline, 4 weeks, 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.
University of Georgia
Other
Comparison of Health Effects of Diets With and Without Pecans
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