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Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk (FitALA)

21 lipca 2017 zaktualizowane przez: Manja Zec, University of Belgrade

Investigation of Health Effects of Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk Towards Established and Molecular Cardiovascular Risk Factors

This cross-over study investigates health effects of dietary intake of whole walnuts towards cardiovascular risk factors in adults under low cardiovascular risk.

Investigators hypothesize that daily intake of whole nuts as a replacement meal, would improve cardiovascular risk factors, including traditional risk factors and molecular biomarkers.

The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.

The study subjects are instructed to continue with their habitual diet and physical activity.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Recent literature data raise important questions on the beneficial effect of dietary fats. Dietary intake of nuts, although with high caloric burden, is however characterized with high intake of fatty acids with known beneficial health effects. Those fatty acids include mono- (MUFA) and polyunsaturated fatty acids (PUFA), to whom beneficial health effects are ascribed.

Among nuts, walnuts are characterized with comparatively high levels of MUFA and PUFA, especially content of alpha-linolenic PUFA, considered essential fatty acid, since not synthesized endogenously in humans. Dietary intake of alpha-linolenic acid is shown to be inversely related with cardiovascular risk factors, both in interventional studies and epidemiological cohorts. Molecular background of alpha-linolenic actions is bidirectional, and includes the action itself, as well as beneficial endogenous conversion towards long-chain fatty acids, including eicosapentaenoic and docosahexaenoic fatty acid.

Although high caloric intake is indicated with intake of walnuts, literature data suggest that consumption of walnuts does not increase body weight.

Dietary intake of walnuts has been shown to decrease cholesterol fractions, triglycerides and apolipoproteins in adult population. Also, consumption of walnuts was associated with decrease in blood pressure.

The study design is cross-over, controlled, randomized nutritional intervention. The participants are randomly assigned to receive either study treatment, or no treatment, and are crossed after five weeks.

The study subjects are instructed to continue with their habitual diet and physical activity. Additionally, study subjects are instructed to avoid walnuts and nuts other then study treatment, during the complete study period of 10 weeks.

Sample size calculation was conducted by use of online calculators, and was based on the low density lipoprotein (LDL) cholesterol. Namely, in order to achieve decrease in 0.5 mmol/L, in a sample with projected standard deviation of 0.7 mmol/L, and type I and II errors being 0.2 and 0.05, respectively, 62 subjects are needed.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

52

Faza

  • Nie dotyczy

Kontakty i lokalizacje

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

Lokalizacje studiów

  • Serbia
      • Belgrade, Serbia, 11000
        • Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade

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

30 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

Presence of at least one of the following criteria, formerly assessed through routine medical examination:

  • dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L)
  • elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy

Exclusion Criteria:

  • presence of allergy on any nuts
  • presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2
  • smoking
  • statin therapy
  • pregnancy and/or lactation

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: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Walnut

At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Treatment arm includes 56 g of whole walnuts daily.
Suplement diety: Whole Walnuts
Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.
Brak interwencji: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in LDL-cholesterol
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Changes in HDL-cholesterol
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in total cholesterol
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in triglycerides
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in glucose metabolism biomarkers
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in renal function parameters
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in renal function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in liver function parameters
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in liver function parameters measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in body weight
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in waist circumference
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in percent of total body fat measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Level of Physical Activity
Ramy czasowe: Baseline
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
Baseline
Psychological parameters
Ramy czasowe: 5 weeks
Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
5 weeks
Changes in hematological parameters
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells
Ramy czasowe: Baseline, 5 weeks, 10 weeks
Changes in number of leukocyte cells, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
Baseline, 5 weeks, 10 weeks
Changes in total caloric intake
Ramy czasowe: Baseline, 5 weeks, 10 weeks

Changes in total caloric intake, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

Total caloric intake is measured by use of standardized dietary questionnaire namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of fats
Ramy czasowe: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of fats, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of carbohydrates
Ramy czasowe: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of carbohydrates, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks
Changes in caloric intake of vitamin D
Ramy czasowe: Baseline, 5 weeks, 10 weeks

Changes in caloric intake of vitamin D, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.

The caloric intake is measured by use of standardized dietary questionnaire, namely 24-hour Dietary Recall.
Baseline, 5 weeks, 10 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Belgrade

Współpracownicy

Centre of Research Excellence in Nutrition and Metabolism

Śledczy

  • Główny śledczy: Maria Glibetic, Prof, Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch

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)

21 kwietnia 2017

Zakończenie podstawowe (Rzeczywisty)

15 lipca 2017

Ukończenie studiów (Rzeczywisty)

15 lipca 2017

Daty rejestracji na studia

Pierwszy przesłany

17 lipca 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lipca 2017

Pierwszy wysłany (Rzeczywisty)

24 lipca 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 lipca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lipca 2017

Ostatnia weryfikacja

1 lipca 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EO120/2017

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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