Diets Enriched With Pecans

Obesity Clinical Trial

Official title:

Comparison of Health Effects of Diets With and Without Pecans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376632
• Other study ID #: STUDY00005985
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher).

Exclusion Criteria:

• Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex)

• Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week

• Hormone replacement therapy <5 years

• Women who are pregnant or planning to become pregnant

• Regular exercise of >3 hours/week

• Weight gain or loss of >5% of body weight during last 3 months

• Plans to begin a weight loss/exercise regiment

• History of medical or surgical events that could affect digestion or swallowing

• Gastrointestinal surgeries, conditions or disorders

• Chronic or metabolic diseases

• Atherosclerosis, previous myocardial infarction, stroke, cancer

• Fasting blood glucose levels >126 mg/dl

• Blood pressure >180/120 mmHg

• Medication use that affects digestion, absorption, metabolism

• Lipid-lowering medications

• Medications for diabetes or attention deficit disorders (with or without hyperactivity)

• Steroid/hormone therapies

• Individuals on medically prescribed or special diet

• Individuals with food allergies to foods specifically in the study

• Individuals taking fish oil supplements

• Excessive alcohol consumption (greater than 3 drinks/d for men; greater than 2 drinks/d for women)

• Tobacco or nicotine use

Related Conditions & MeSH terms

• Hypercholesterolemia
• Obesity

Intervention

Dietary Supplement:
• Pecan ADD
Raw pecan halves without dietary substitution instructions
• Pecan SUB
Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet

Locations

Country	Name	City	State
United States	University of Georgia- Department of Foods and Nutrition	Athens	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
University of Georgia	Georgia Pecan Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks	LDL peak size (angstrom)	Baseline, 4 weeks, 8 weeks
Primary	Change in baseline weight at 4 and 8 weeks	Weight (kg)	Baseline, 4 weeks, 8 weeks
Primary	Change in baseline waist and hip circumference at 4 and 8 weeks	waist and hip circumference (cm)	Baseline, 4 weeks, 8 weeks
Primary	Change in baseline total body fat percentage at 4 and 8 weeks	Total body fat percentage (%)	Baseline, 4 weeks, 8 weeks
Secondary	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.
Secondary	Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks	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.
Secondary	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.
Secondary	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.
Secondary	Change in resting metabolic rate (RMR) from baseline to 8 weeks	RMR (kcals/d) measured via indirect calorimetry	Baseline and 8 weeks
Secondary	Change in diet induced thermogenesis (DIT) from baseline to 8 weeks	DIT (kcals) measured via indirect calorimetry	Baseline and 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.