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Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults

22 agosto 2019 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

41

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.

Luoghi di studio

    • Oregon
      • Corvallis, Oregon, Stati Uniti, 97331
        • Linus Pauling Science Center

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

55 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in Plasma Micronutrient Levels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lipid Status
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

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

Collaboratori

Investigatori

  • Investigatore principale: Maret G Traber, PhD, Oregon State University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

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 (Effettivo)

22 giugno 2016

Completamento primario (Effettivo)

18 settembre 2017

Completamento dello studio (Effettivo)

29 dicembre 2017

Date di iscrizione allo studio

Primo inviato

13 marzo 2018

Primo inviato che soddisfa i criteri di controllo qualità

26 marzo 2018

Primo Inserito (Effettivo)

3 aprile 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 6988

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

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