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Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

6 augustus 2026 bijgewerkt door: Jamie Cooper, PhD, University of Georgia

Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose: A 12-Week Randomized Controlled 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Georgia
      • Athens, Georgia, Verenigde Staten, 30602
        • University of Georgia
        • Contact:
        • Hoofdonderzoeker:
          • Jamie A Cooper, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 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.
  • Elevated cholesterol profiles will be defined as:
  • "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).

Exclusion Criteria:

  • 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
  • Weight gain or loss of more than 5% body weight in the past 3 months
  • Plans to begin a weight loss/exercise regimen during the trial
  • History of medical or surgical events that could affect digestion or swallowing
  • Gastrointestinal surgeries, conditions, or disorders
  • Any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease)
  • Metabolic disease
  • Atherosclerosis
  • Previous MI or stroke
  • Cancer
  • Fasting blood glucose levels greater than 126 mg/dL
  • Blood pressure greater than 180/120 mmHg
  • Medication use affecting digestion, absorption, or metabolism (e.g. thyroid meds), lipid-lowering medications, medications for diabetes, steroid/hormone therapies, or current antibiotic cycles
  • Medically prescribed or special diets
  • Food allergies (specific to the foods in the study, including tree nuts, dairy, gluten, palm oil, and coconut oil)
  • Fish oil supplements
  • Individuals who regularly consume nuts and/or nut butter (defined as consumption of >2 servings (~56g) of tree nuts, nuts, or nut butter (e.g., peanut butter, almond butter) per week
  • Excessive alcohol use (greater than 3 drinks/day for men; greater than 2 drinks/day for women)
  • Tobacco or nicotine use
  • Underweight BMI (<18.5 kg/m²)
  • Individuals who have donated blood or plasma in the past 2 weeks
  • Anemia or hemoglobin levels <13.0 g/dL (men) or <12.5 (women)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Pecan
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.
Experimenteel: Control
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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in fasting serum lipoprotein and cholesterol concentrations
Tijdsspanne: baseline, 12 weeks
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)
baseline, 12 weeks
Change in fasting and postprandial plasma lipid concentrations
Tijdsspanne: baseline, 12 weeks
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)
baseline, 12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in fasting and postprandial plasma appetite control hormone concentrations
Tijdsspanne: baseline, 12 weeks
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)
baseline, 12 weeks
Change in fasting and postprandial subjective feelings related to appetite
Tijdsspanne: baseline, 12 weeks
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).
baseline, 12 weeks
Change in acute dietary intake
Tijdsspanne: baseline, 12 weeks
One-day food logs will be used to record all foods and beverages consumed on testing days
baseline, 12 weeks
Change in fasting and postprandial plasma Malondialdehyde (MDA)
Tijdsspanne: baseline, 12 weeks
The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).
baseline, 12 weeks
Change in fasting and postprandial plasma total antioxidant capacity
Tijdsspanne: baseline, 12 weeks
Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).
baseline, 12 weeks
Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
Tijdsspanne: baseline, 12 weeks
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)
baseline, 12 weeks
Change in fasting and postprandial plasma insulin concentrations
Tijdsspanne: baseline, 12 weeks
The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post- intervention visits (uU/mL)
baseline, 12 weeks
Change in fasting and postprandial plasma glucose concentrations
Tijdsspanne: baseline, 12 weeks
The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg/dL)
baseline, 12 weeks
Change in fasting inflammatory cytokine concentrations
Tijdsspanne: baseline, 12 weeks
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).
baseline, 12 weeks
Change in overall liking and desire to consume subjective ratings of the intervention food provided
Tijdsspanne: 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
Visual analog scale ratings of feelings related to overall liking and desire to consume the intervention food are measured by visual analog scales (mm).
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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Ruststofwisseling
Tijdsspanne: Screening
De ruststofwisseling (RMR) wordt gedurende 30 minuten gemeten op de TrueOne 2400 (Parvo Medics, Sandy, UT)
Screening
Verandering in zelfgerapporteerde fysieke activiteitsniveaus
Tijdsspanne: baseline, week 4, week 8
De Internationale Fysieke Activiteiten Vragenlijst zal worden gebruikt om zelfgerapporteerde gemiddelde fysieke activiteitsniveaus (met/min) te verzamelen
baseline, week 4, week 8
Change in blood pressure
Tijdsspanne: baseline, 12 weeks
Systolic and diastolic blood pressure (mmHg)
baseline, 12 weeks
Change in body weight
Tijdsspanne: baseline, 12 weeks
body weight (kg)
baseline, 12 weeks
Change in body composition
Tijdsspanne: baseline, 12 weeks
DXA will be used to measure body fat percentage (body fat %)
baseline, 12 weeks
Change in diet composition
Tijdsspanne: baseline, week 4, week 8
3-day food records will be used to record foods and beverages consumed before and during the 12-week intervention period
baseline, week 4, week 8
Change in fasting tocopherol concentrations
Tijdsspanne: baseline, 12 weeks
Plasma tocopherol concentrations (ug/mL)
baseline, 12 weeks
Change in fasting urolithin concentrations
Tijdsspanne: baseline, 12 weeks
Plasma urolithin concentrations (ng/mL).
baseline, 12 weeks
Change in anthropometric circumferences
Tijdsspanne: baseline, 12 weeks
hip and waist circumferences (cm)
baseline, 12 weeks
Change in Perceived Stress
Tijdsspanne: baseline, 12 weeks
Perceived Stress Scale will be administered and scored to determine stress levels
baseline, 12 weeks
Change in anxiety
Tijdsspanne: baseline, 12 weeks
The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels
baseline, 12 weeks
Change in Body Mass Index (BMI)
Tijdsspanne: baseline, 12 weeks
BMI will be calculated based on height and weight measures (kg/m²)
baseline, 12 weeks
Change in highly processed food (HPF) consumption
Tijdsspanne: baseline, 12 weeks
The Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF) will be administered and scored to determine HPF consumption
baseline, 12 weeks
Change in pro-inflammatory and anti-inflammatory food consumption
Tijdsspanne: baseline, 12 weeks
The Anti-Inflammatory Diet Index-20 (AIDI-20) Inspired Questionnaire will be administered and scored to determine pro-inflammatory and anti-inflammatory food consumption
baseline, 12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Jamie A Cooper, PhD, University of Georgia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 maart 2027

Primaire voltooiing (Geschat)

1 juli 2029

Studie voltooiing (Geschat)

1 februari 2030

Studieregistratiedata

Eerst ingediend

6 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

6 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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