An interventional study of Pecan and Control in Nutrition, Healthy, Dyslipidemia and Overweight and Obesity, sponsored by University of Georgia. Not yet recruiting at 1 site in United States. Open to participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by University of Georgia · Not applicable, Interventional, and Prevention
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:
Participants will be asked to:
Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.
Accounting for nearly 1 in every 4 deaths in the U.S., cardiovascular disease (CVD) is the leading cause of death for adults. One risk factor for CVD is hypercholesterolemia, which can double the risk for this disease. Research investigating the relationship between pecan nut consumption and cardiometabolic outcomes has shown that pecan nut consumption can significantly benefit fasting and postprandial blood lipids, reduce CVD risk factors, promote weight maintenance, improve subjective and psychological markers of physiological appetite, increase total antioxidant capacity, and increase energy expenditure and fat oxidation. However, the current literature on pecan consumption and health outcomes only encompasses physiological benefits coming from a dosage of \~ 45g/day and above, which is above the current dietary guidelines. Recent evidence from our pecan dose-response study showed that consuming 6% of energy needs from pecans (\~ 21.5 g/day) trended toward reductions in blood lipids but did not reach significance by the end of the short, 4-week intervention. Based on previous interventions with low doses of tree nuts, a longer duration, such as 12 weeks, may be needed to see significant effects. If lower doses of pecans in the diet are found to improve fasting and postprandial lipid metabolism and markers of chronic disease risk, these study findings could lead to improvements in health and possibly provide additional information about dietary guidelines for nut consumption.
This prospective clinical study is a single-blinded, randomized control trial in adults at increased risk for cardiovascular disease (poor cholesterol profiles and/or overweight/obesity). There are two diet interventions: Pecan (6% of energy needs from pecans) and Control (instructed to maintain their current habitual diet, but abstain from any tree nut/peanut consumption and limit nut butters to no more than 2x/wk during the intervention). The study protocol consists of a 12-week intervention that will involve substituting pecans for commonly consumed snack or meal items every day for the entire 12-week intervention or maintaining a current/usual diet.
There are a total of 5 testing visits: screening (v0), pre-intervention (v1), 2 short visits at 4 and 8 weeks (v2, v3), and post-intervention (v4).
At screening (v0), qualification is confirmed based on anthropometrics and a fasting blood draw, which is analyzed for a cholesterol panel and blood glucose. Additionally, energy requirements are estimated at this visit for use in the diet intervention.
At v1, participants will have anthropometrics measured, including body composition by dual-energy x-ray absorptiometry (DXA). Fasting and postprandial blood draws for a 4h period will occur following a high saturated-fat meal challenge which delivers 17% of the participant's estimated energy needs.
12-week dietary intervention: The 12-week diet intervention will consist of research personnel providing pecans that deliver 6% of the participant's daily energy needs (determined at V0). Participants randomized in the pecan group will receive dietary counseling at the baseline (V1) and intervention visits at 4 and 8 weeks (V2-V3) on substituting pecans for isocaloric foods from their habitual diet. Individuals randomized in the control group will be instructed to follow their habitual diet, but avoid any tree nut/peanut consumption and limit nut butter to no more than 2x/wk, and will not be provided with any food items.
Participants return at 4 and 8 weeks (v2, v3) to return study materials and collect pecans for the next four weeks (if applicable). At these mid-intervention visits, participants also have a fasting blood draw and body measures taken.
At the end of the 12-week dietary intervention, participants return for v4, where all procedures from v1 are repeated.
As decided a priori, we will complete a per protocol analysis. The investigators hypothesize that including the daily consumption of pecans will improve the proposed overall health outcomes and markers of chronic disease risk compared to the control group.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 986 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →University of Georgia is the lead sponsor of 74 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Other: Pecan
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.
Other: Control
Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.
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.
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
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 weeks
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
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 weeks
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 weeks
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 weeks
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
Change in fasting and postprandial plasma glucose concentrations
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg/dL)
Time frame: baseline, 12 weeks
Change in fasting inflammatory cytokine concentrations
The concentration of glycoprotein acetylation (GlycA), interleukin-1 beta, C-reactive protein, tumor-necrosis factor-alpha, interleukin-10, and interleukin-6 at fasting at both pre-and post-intervention visits (pg/mL).
Time frame: baseline, 12 weeks
Change in acute dietary intake
One-day food logs will be used to record all foods and beverages consumed on testing days
Time frame: baseline, 12 weeks
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
The concentration of ANGPTL 3, ANGPTL 4, and ANGPTL 8 before and after the high saturated fat meal challenge at both pre- and post-intervention visits (ng/mL)
Time frame: baseline, 12 weeks
Change in overall liking and desire to consume subjective ratings of the intervention food provided
Visual analog scale ratings of feelings related to overall liking and desire to consume the intervention food are measured by visual analog scales (mm).
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
Change in blood pressure
Systolic and diastolic blood pressure (mmHg)
Time frame: baseline, 12 weeks
Change in body weight
body weight (kg)
Time frame: baseline, 12 weeks
Change in body composition
DXA will be used to measure body fat percentage (body fat %)
Time frame: baseline, 12 weeks
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
Change in fasting tocopherol concentrations
Plasma tocopherol concentrations (ug/mL)
Time frame: baseline, 12 weeks
Change in fasting urolithin concentrations
Plasma urolithin concentrations (ng/mL).
Time frame: baseline, 12 weeks
Change in anthropometric circumferences
hip and waist circumferences (cm)
Time frame: baseline, 12 weeks
Resting metabolic rate
Resting metabolic rate (RMR) will be measured for 30 minutes on the TrueOne 2400 (Parvo Medics, Sandy, UT)
Time frame: Screening
Change in Perceived Stress
Perceived Stress Scale will be administered and scored to determine stress levels
Time frame: baseline, 12 weeks
Change in anxiety
The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels
Time frame: baseline, 12 weeks
Change in self reported physical activity levels
The International Physical Activity Questionnaire will be used to collect self-reported average physical activity levels (met/min)
Time frame: baseline, week 4, week 8
Change in Body Mass Index (BMI)
BMI will be calculated based on height and weight measures (kg/m²)
Time frame: baseline, 12 weeks
Change in highly processed food (HPF) consumption
The Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF) will be administered and scored to determine HPF consumption
Time frame: baseline, 12 weeks
Change in pro-inflammatory and anti-inflammatory food consumption
The Anti-Inflammatory Diet Index-20 (AIDI-20) Inspired Questionnaire will be administered and scored to determine pro-inflammatory and anti-inflammatory food consumption
Time frame: baseline, 12 weeks
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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