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Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

ConditionsNutrition, HealthyDyslipidemiaOverweight and Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-75
SponsorUniversity of Georgia

About this trial

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:

* Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on fasting and postprandial blood lipids. * Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on other markers of chronic disease risk.

Participants will be asked to:

* Consume pecans daily for 12 weeks or maintain their current habitual diet. * Attend two short visits at 4 and 8 weeks for fasting blood draws, body measurements, and to collect their next 4 weeks' supply of study materials. * Attend two longer (5 h) testing visits, which include eating a standard breakfast meal and having their blood drawn periodically before and after breakfast.

Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

25-75 year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight/obesity.

"Borderline High" and/or "at risk" in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) --or-- "High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL).

Overweight/obesity will be defined by body mass index (overweight > 28 kg/m2 or obesity 30 kg/m2 or greater).

Disqualifiers

Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative.

Women on hormone replacement therapy less than 2 years.

Women who are pregnant or nursing

Individuals who regularly exercise more than 3h/w

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pecan

    Other intervention

    Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.

  • Control

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: PecanExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
baseline, 12 weeks
2

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)

Time frame
baseline, 12 weeks
3

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)

Time frame
baseline, 12 weeks
4

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)

Time frame
baseline, 12 weeks

Secondary outcomes

1

Change in fasting serum hepatic enzymes

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L)

Time frame
baseline, 12 weeks
2

Change in fasting serum hepatic proteins

Total protein and albumin (g/dL)

Time frame
baseline, 12 weeks
3

Change in fasting serum bilirubin

Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)

Time frame
baseline, 12 weeks
4

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)

Time frame
baseline, 12 weeks

Other outcomes

1

Change in blood pressure

Systolic and diastolic blood pressure (mmHg)

Time frame
baseline, 12 weeks
2

Change in body weight

body weight (kg)

Time frame
baseline, 12 weeks
3

Change in body composition

DXA will be used to measure body fat percentage (body fat %)

Time frame
baseline, 12 weeks
4

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

Time frame
baseline, week 4, week 8

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Georgia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: