Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose
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
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
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Jamie A Cooper, PhD
- 電話番号:706-542-4378
- メール:jamie.cooper@uga.edu
研究場所
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Georgia
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Athens、Georgia、アメリカ、30602
- University of Georgia
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コンタクト:
- Jamie A Cooper, PhD
- 電話番号:706-542-4378
- メール:jamie.cooper@uga.edu
-
主任研究者:
- Jamie A Cooper, PhD
-
-
参加基準
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
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
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 |
|---|---|
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実験的:Pecan
Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.
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Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.
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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.
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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
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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)
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baseline, 12 weeks
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Change in fasting and postprandial plasma lipid concentrations
時間枠:baseline, 12 weeks
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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)
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baseline, 12 weeks
|
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Change in fasting and postprandial subjective feelings related to appetite
時間枠:baseline, 12 weeks
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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).
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baseline, 12 weeks
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Change in acute dietary intake
時間枠:baseline, 12 weeks
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One-day food logs will be used to record all foods and beverages consumed on testing days
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baseline, 12 weeks
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Change in fasting and postprandial plasma Malondialdehyde (MDA)
時間枠:baseline, 12 weeks
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The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).
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baseline, 12 weeks
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Change in fasting and postprandial plasma total antioxidant capacity
時間枠:baseline, 12 weeks
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Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).
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baseline, 12 weeks
|
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Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins
時間枠:baseline, 12 weeks
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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)
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baseline, 12 weeks
|
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Change in fasting and postprandial plasma insulin concentrations
時間枠:baseline, 12 weeks
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The concentration of plasma insulin before and after the high saturated fat meal challenge at both pre- and post- intervention visits (uU/mL)
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baseline, 12 weeks
|
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Change in fasting and postprandial plasma glucose concentrations
時間枠:baseline, 12 weeks
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The concentration of plasma glucose before and after the high saturated fat meal challenge at both pre- and post- intervention visits (mg/dL)
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baseline, 12 weeks
|
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Change in fasting inflammatory cytokine concentrations
時間枠:baseline, 12 weeks
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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).
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baseline, 12 weeks
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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
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Visual analog scale ratings of feelings related to overall liking and desire to consume the intervention food are measured by visual analog scales (mm).
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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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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安静時代謝率
時間枠:スクリーニング
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安静時代謝率(RMR)はTrueOne 2400 (Parvo Medics, Sandy, UT)で30分間測定されます
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スクリーニング
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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
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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。
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ベースライン、4週目、8週目
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Change in blood pressure
時間枠:baseline, 12 weeks
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Systolic and diastolic blood pressure (mmHg)
|
baseline, 12 weeks
|
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Change in body weight
時間枠:baseline, 12 weeks
|
body weight (kg)
|
baseline, 12 weeks
|
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Change in body composition
時間枠:baseline, 12 weeks
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DXA will be used to measure body fat percentage (body fat %)
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baseline, 12 weeks
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Change in diet composition
時間枠:baseline, week 4, week 8
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3-day food records will be used to record foods and beverages consumed before and during the 12-week intervention period
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baseline, week 4, week 8
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Change in fasting tocopherol concentrations
時間枠:baseline, 12 weeks
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Plasma tocopherol concentrations (ug/mL)
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baseline, 12 weeks
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Change in fasting urolithin concentrations
時間枠:baseline, 12 weeks
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Plasma urolithin concentrations (ng/mL).
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baseline, 12 weeks
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Change in anthropometric circumferences
時間枠:baseline, 12 weeks
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hip and waist circumferences (cm)
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baseline, 12 weeks
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Change in Perceived Stress
時間枠:baseline, 12 weeks
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Perceived Stress Scale will be administered and scored to determine stress levels
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baseline, 12 weeks
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Change in anxiety
時間枠:baseline, 12 weeks
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The State Trait Anxiety Inventory will be administered and scored to determine anxiety levels
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baseline, 12 weeks
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Change in Body Mass Index (BMI)
時間枠:baseline, 12 weeks
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BMI will be calculated based on height and weight measures (kg/m²)
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baseline, 12 weeks
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Change in highly processed food (HPF) consumption
時間枠:baseline, 12 weeks
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The Screening Questionnaire of Highly Processed Food Consumption (sQ-HPF) will be administered and scored to determine HPF consumption
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baseline, 12 weeks
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Change in pro-inflammatory and anti-inflammatory food consumption
時間枠:baseline, 12 weeks
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The Anti-Inflammatory Diet Index-20 (AIDI-20) Inspired Questionnaire will be administered and scored to determine pro-inflammatory and anti-inflammatory food consumption
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baseline, 12 weeks
|
協力者と研究者
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
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。