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Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

6 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Georgia
      • Athens, Georgia, Stati Uniti, 30602
        • University of Georgia
        • Contatto:
        • Investigatore principale:
          • Jamie A Cooper, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fasting serum lipoprotein and cholesterol concentrations
Lasso di tempo: 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 triglyceride concentrations
Lasso di tempo: baseline, 12 weeks
The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)
baseline, 12 weeks
Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations
Lasso di tempo: baseline, 12 weeks
The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)
baseline, 12 weeks
Change in fasting and postprandial plasma appetite control hormone concentrations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in fasting serum hepatic enzymes
Lasso di tempo: baseline, 12 weeks
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP) (U/L)
baseline, 12 weeks
Change in fasting serum hepatic proteins
Lasso di tempo: baseline, 12 weeks
Total protein and albumin (g/dL)
baseline, 12 weeks
Change in fasting serum bilirubin
Lasso di tempo: baseline, 12 weeks
Total bilirubin, direct bilirubin and indirect bilirubin (mg/dL)
baseline, 12 weeks
Change in fasting and postprandial plasma insulin concentrations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 fasting plasma markers of coagulation potential
Lasso di tempo: baseline, 12 weeks
The concentration of plasminogen activator inhibitor-1, fibrinogen, tissue factor, Von Willebrand factor, tissue factor pathway inhibitor, and D-dimer at fasting for both pre- and post-intervention visits (pg/mL)
baseline, 12 weeks
Change in fasting insulin resistance metrics
Lasso di tempo: baseline, 12 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) and homeostatic model assessment for beta cell function (HOMA-B) will be calculated from fasting insulin and glucose measures before and after the 12-week intervention.
baseline, 12 weeks
Change in overall liking and desire to consume subjective ratings of the intervention food provided
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Tasso metabolico a riposo
Lasso di tempo: Screening
Il tasso metabolico a riposo (RMR) verrà misurato per 30 minuti sul TrueOne 2400 (Parvo Medics, Sandy, UT)
Screening
Variazione dei livelli di attività fisica auto-riportati
Lasso di tempo: baseline, settimana 4, settimana 8
Il Questionario Internazionale sull'Attività Fisica sarà utilizzato per raccogliere i livelli medi di attività fisica auto-riferiti (met/min)
baseline, settimana 4, settimana 8
Change in blood pressure
Lasso di tempo: baseline, 12 weeks
Systolic and diastolic blood pressure (mmHg)
baseline, 12 weeks
Change in body weight
Lasso di tempo: baseline, 12 weeks
body weight (kg)
baseline, 12 weeks
Change in body composition
Lasso di tempo: baseline, 12 weeks
DXA will be used to measure body fat percentage (body fat %)
baseline, 12 weeks
Change in diet composition
Lasso di tempo: 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
Lasso di tempo: baseline, 12 weeks
Plasma tocopherol concentrations (ug/mL)
baseline, 12 weeks
Change in fasting urolithin concentrations
Lasso di tempo: baseline, 12 weeks
Plasma urolithin concentrations (ng/mL).
baseline, 12 weeks
Change in anthropometric circumferences
Lasso di tempo: baseline, 12 weeks
hip and waist circumferences (cm)
baseline, 12 weeks
Change in Perceived Stress
Lasso di tempo: baseline, 12 weeks
Perceived Stress Scale will be administered and scored to determine stress levels
baseline, 12 weeks
Change in anxiety
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Jamie A Cooper, PhD, University of Georgia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 luglio 2029

Date di iscrizione allo studio

Primo inviato

6 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Pecan

3
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