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

21 luglio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

52

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

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

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

Da 30 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Integratore alimentare: 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.
Nessun intervento: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in LDL-cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Changes in HDL-cholesterol
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
Baseline
Psychological parameters
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

University of Belgrade

Collaboratori

Centre of Research Excellence in Nutrition and Metabolism

Investigatori

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

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)

21 aprile 2017

Completamento primario (Effettivo)

15 luglio 2017

Completamento dello studio (Effettivo)

15 luglio 2017

Date di iscrizione allo studio

Primo inviato

17 luglio 2017

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2017

Primo Inserito (Effettivo)

24 luglio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EO120/2017

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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