Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose
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 volunteersQualifiers
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 interventionParticipants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.
Control
Other interventionParticipants 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 groupsGroup 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 weeks2
Change in fasting and postprandial plasma lipid concentrations
The concentration of plasma triglycerides and non-esterified fatty acids before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)
Time frame
baseline, 12 weeksSecondary outcomes
1
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 weeks2
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).
Time frame
baseline, 12 weeks3
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).
Time frame
baseline, 12 weeks4
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).
Time frame
baseline, 12 weeksOther outcomes
1
Change in blood pressure
Systolic and diastolic blood pressure (mmHg)
Time frame
baseline, 12 weeks2
Change in body weight
body weight (kg)
Time frame
baseline, 12 weeks3
Change in body composition
DXA will be used to measure body fat percentage (body fat %)
Time frame
baseline, 12 weeks4
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 8Sponsors and contacts
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Source ClinicalTrials.gov
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