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Role of Hazelnut Consumption in Improving Micronutrient Status in Older Adults

22 sierpnia 2019 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

41

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Oregon
      • Corvallis, Oregon, Stany Zjednoczone, 97331
        • Linus Pauling Science Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

55 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in Plasma Micronutrient Levels
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Lipid Status
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Śledczy

  • Główny śledczy: Maret G Traber, PhD, Oregon State University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 czerwca 2016

Zakończenie podstawowe (Rzeczywisty)

18 września 2017

Ukończenie studiów (Rzeczywisty)

29 grudnia 2017

Daty rejestracji na studia

Pierwszy przesłany

13 marca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 marca 2018

Pierwszy wysłany (Rzeczywisty)

3 kwietnia 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 sierpnia 2019

Ostatnia weryfikacja

1 sierpnia 2019

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 6988

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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