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Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults

2019年8月22日 更新者:Maret Traber、Oregon State University

With advancing age, older adults are susceptible to vitamin and mineral deficiencies for a variety of reasons. Nutrient-dense food sources of vitamin E and other key vitamins and minerals, like hazelnuts, may offer a simple means of improving nutritional status of healthy older adults.

This hypothesis is that individuals eating hazelnuts everyday will result in measurable increases in magnesium and vitamin E levels, two under-consumed micronutrients among older adults. Thus, subjects will consume two ounces (56 g) of hazelnuts each day for sixteen weeks. Investigators will measure vitamin E and magnesium levels along with a general assessment of micronutrient status as primary outcomes. Since nuts are nutrient-rich sources of unsaturated fatty acids but low in carbohydrates, changes in fasting glucose, lipid and lipoprotein profiles, and BMI will also be determined (secondary outcomes).

調査の概要

詳細な説明

Older adults are at increased risk of various chronic diseases where inadequate levels of vitamins and minerals may play a significant role, including cardiovascular disease, Alzheimer's disease, liver disease, and cancer. Older adults are increasingly more susceptible to vitamin and mineral deficiencies with changes in dietary preferences, changes in socioeconomic status, decreased consumption of a variety of foods, poor absorption in the gut, and an increased demand for many of these micronutrients with advanced age.

Epidemiological studies and recent clinical trials have shown that use of multivitamin/mineral or single nutrient supplements, such as vitamin E, have beneficial effects on disease risk, but many people are hesitant to use dietary supplements due to reports of ineffectiveness or potential negative effects. However, food sources of vitamin E and other key vitamins and minerals continue to show health benefits. As an alternative to mandating consumption of multivitamin and mineral supplements or food fortification, a dietary solution is to increase consumption of nutrient-dense foods, like hazelnuts.

Tree nuts, including hazelnuts, contain a wide variety of vitamins and minerals, and are particularly good source of vitamin E and magnesium, two "shortfall nutrients" that are lacking in the typical American diet. Over 90% of U.S. adults do not meet recommended intake levels of vitamin E, and 60% do not get enough magnesium. Tree nuts are also a good source of protein and fiber and are high in healthful unsaturated fatty acids and phytochemicals such as flavonoids and phytosterols.

Most clinical studies on the benefits of nut consumption have been conducted using almonds and walnuts, with hazelnuts used less frequently. However, the health benefits of consuming hazelnuts have been demonstrated in many clinical trials, including lower blood glucose levels, alterations in blood lipids, and declines in biomarkers of oxidative stress. Although several clinical trials have investigated nutritional impact of hazelnuts in adults, no clinical trials with hazelnuts have focused on examining micronutrient status and potential health benefits only in older (≥55 years) adults.

Determination of body status of many micronutrients can be difficult, especially so the evaluation of vitamin E levels when age is considered as a factor. Although serum α-tocopherol levels are generally higher in adults above the age of 50 compared to younger adults, the increased prevalence of hypercholesterolemia in older adults makes interpretation of circulating α-tocopherol levels difficult. Alternatively, urinary α- and γ-carboxyethyl hydroxychromanol (α- and γ-CEHC) is believed to be a biomarker of α- and γ-tocopherol status that changes with vitamin E intake. In particular, low α-CEHC excretion is considered a reliable marker of poor α-tocopherol status, while an increase in α-CEHC is indicative of adequate α-tocopherol status.

The objective of this study was to determine whether daily hazelnut consumption by healthy older adults for 16 weeks improves biomarkers of micronutrient status, especially vitamin E and magnesium. For a detailed assessment of vitamin E status, plasma α- and γ-tocopherol concentrations were determined together with urinary α- and γ-CEHC levels. In addition, a commercially available lymphocyte proliferation assay was utilized to evaluate the status of several other micronutrients. Since hazelnut consumption is reported to reduce blood lipids and improve glucose homeostasis, these biomarkers were also monitored in our study.

研究の種類

介入

入学 (実際)

41

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。

研究場所

    • Oregon
      • Corvallis、Oregon、アメリカ、97331
        • Linus Pauling Science Center

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

55年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Must be generally healthy
  • Women must be post-menopausal (12 months period-free) or surgically sterile.
  • Must be willing to eat two ounces (56 g) of dry roasted hazelnuts each day during the study
  • Must refrain from taking nutritional supplements during the study
  • Must follow a diet that excludes all nuts (other than those supplied), seeds, and other vitamin E-rich foods (see Restricted Foods and Supplements document)
  • Must be willing to complete food frequency questionnaires
  • Must be willing to give blood samples on 3 separate occasions and urine on 2 separate occasions

Exclusion Criteria:

  • Current or past (two years) use of any tobacco (including e-cigarettes) and marijuana products
  • Allergy to any nut including tree nuts and peanuts, or hazelnut pollen
  • History of asthma
  • Vitamin E supplement use during the last three months or regular use of vitamin E-enriched nutritional drinks (e.g. Ensure)
  • Regular nut eaters: individuals that regularly consume > 3.5 ounces (112 g) of almonds, hazelnuts and/or sunflower seeds per week in any form (e.g. nuts, nut butters, nut oil, etc.), and no more than 10 mg alpha-tocopherol (vitamin E) per day from their diet.
  • Bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), or serious chronic illness including Crohn's disease, celiac disease, diverticulitis, chronic diarrhea, ulcerative colitis, gastritis
  • History of cardiovascular disease including stroke, heart attack, or congestive heart failure
  • Any history of arterial bypass or stent placement.
  • History of emphysema or chronic obstructive pulmonary disease (COPD)
  • Stage II hypertension (either systolic pressure > 159 mm Hg or diastolic pressure 99 mm Hg)
  • History of cancer during the previous 5 years
  • Diabetes (type 1 or type 2) or use of drugs to lower blood sugar or increase insulin production or sensitivity
  • Use of medications to lower cholesterol other than statins
  • Use of medications to decrease fat or cholesterol absorption
  • Unwillingness to refrain from taking dietary supplements (except calcium and vitamin D and vitamin B12), magnesium-containing drugs such as certain antacids, stool softeners and laxatives
  • BMI < 18.5 or > 35
  • Blood chemistry limits; any of the following at screening excludes participation:

    • Fasting blood glucose ≥ 126 mg/dL
    • LDL cholesterol ≥160 mg/dL
    • Triglyceride ≥200 mg/dL
    • High-sensitivity C-reactive protein (hsCRP) > 10 mg/L

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:基礎科学
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Hazelnuts
Participants given 2 ounces (~57 grams) of dry roasted hazelnuts to consume each day.
Dry roasted, individually packaged hazelnuts provided from the Hazelnuts Marketing Board of Oregon

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
Changes in Plasma Micronutrient Levels
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Plasma levels of magnesium and vitamin E (alpha and gamma tocopherol) at baseline and 16 weeks after hazelnut intervention will be determined. Vitamin E analyses will be performed as absolute concentrations and concentrations corrected for total plasma lipids.
Between baseline (Visit 2) and 16 weeks (last visit)
Changes in Plasma Urine Vitamin E Metabolites
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Urine concentrations of alpha and gamma carboxyethyl hydroxychroman (metabolites of alpha and gamma tocopherol, respectively) will be determined at baseline and 16 weeks after hazelnut intervention. Urine values will be corrected for creatinine levels.
Between baseline (Visit 2) and 16 weeks (last visit)
Changes in Lymphocyte Proliferation Assay
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Blood samples will be collected and sent to Spectracell Labs, Inc. for a functional micronutrient analysis utilizing their proprietary lymphocyte proliferation assay. Micronutrient levels in these white blood cell samples will be assessed by changes in lymphocyte proliferation in the absence of a given vitamin or mineral, suggesting functional inadequacies that may not correspond to plasma values. Data will be represented as percent difference in cell proliferative capacity in cells growing in a complete media vs. a single-nutrient deprived media.
Between baseline (Visit 2) and 16 weeks (last visit)

二次結果の測定

結果測定
メジャーの説明
時間枠
Lipid Status
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Lipid profile will be determined from samples blood sent to a CLIA(Clinical Laboratory Improvement Amendments)-certified laboratory. Changes to fasting lipoprotein and triglyceride status determined before and after hazelnut intervention.
Between baseline (Visit 2) and 16 weeks (last visit)
Glucose Homeostasis
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Glucose and insulin levels will be determined from blood samples to a CLIA-certified laboratory. Changes to fasting glucose levels and insulin levels determined before and after hazelnut intervention.
Between baseline (Visit 2) and 16 weeks (last visit)
BMI
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Height and weight will be measured by stadiometer and scale. Changes to height and weight will be expressed as BMI calculated before and after hazelnut intervention.
Between baseline (Visit 2) and 16 weeks (last visit)
Blood Pressure
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Changes to resting systolic and diastolic blood pressure (mmHg) will be measured by sphygmomanometer before and after hazelnut intervention.
Between baseline (Visit 2) and 16 weeks (last visit)
Heart Rate
時間枠:Between baseline (Visit 2) and 16 weeks (last visit)
Resting heart rate will be measured manually using the ventral aspect of radial artery.
Between baseline (Visit 2) and 16 weeks (last visit)

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:Maret G Traber, PhD、Oregon State University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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 (実際)

2016年6月22日

一次修了 (実際)

2017年9月18日

研究の完了 (実際)

2017年12月29日

試験登録日

最初に提出

2018年3月13日

QC基準を満たした最初の提出物

2018年3月26日

最初の投稿 (実際)

2018年4月3日

学習記録の更新

投稿された最後の更新 (実際)

2019年8月28日

QC基準を満たした最後の更新が送信されました

2019年8月22日

最終確認日

2019年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 6988

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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いいえ

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