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Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

2026年8月6日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Georgia
      • Athens、Georgia、アメリカ、30602
        • University of Georgia
        • コンタクト:
        • 主任研究者:
          • Jamie A Cooper, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in fasting serum lipoprotein and cholesterol concentrations
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in fasting and postprandial plasma appetite control hormone concentrations
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
安静時代謝率
時間枠:スクリーニング
安静時代謝率(RMR)はTrueOne 2400 (Parvo Medics, Sandy, UT)で30分間測定されます
スクリーニング
自己申告による身体活動レベルの変化
時間枠:ベースライン、4週目、8週目
国際身体活動質問票は、自己申告による平均身体活動レベル(met/分)を収集するために使用されます。
ベースライン、4週目、8週目
Change in blood pressure
時間枠:baseline, 12 weeks
Systolic and diastolic blood pressure (mmHg)
baseline, 12 weeks
Change in body weight
時間枠:baseline, 12 weeks
body weight (kg)
baseline, 12 weeks
Change in body composition
時間枠:baseline, 12 weeks
DXA will be used to measure body fat percentage (body fat %)
baseline, 12 weeks
Change in diet composition
時間枠: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
時間枠:baseline, 12 weeks
Plasma tocopherol concentrations (ug/mL)
baseline, 12 weeks
Change in fasting urolithin concentrations
時間枠:baseline, 12 weeks
Plasma urolithin concentrations (ng/mL).
baseline, 12 weeks
Change in anthropometric circumferences
時間枠:baseline, 12 weeks
hip and waist circumferences (cm)
baseline, 12 weeks
Change in Perceived Stress
時間枠:baseline, 12 weeks
Perceived Stress Scale will be administered and scored to determine stress levels
baseline, 12 weeks
Change in anxiety
時間枠: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)
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Jamie A Cooper, PhD、University of Georgia

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2029年7月1日

研究の完了 (推定)

2030年2月1日

試験登録日

最初に提出

2026年7月6日

QC基準を満たした最初の提出物

2026年7月6日

最初の投稿 (実際)

2026年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月11日

QC基準を満たした最後の更新が送信されました

2026年8月6日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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