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

21 juillet 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

52

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Complément alimentaire: 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.
Aucune intervention: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in LDL-cholesterol
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in HDL-cholesterol
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline
Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
Baseline
Psychological parameters
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Belgrade

Collaborateurs

Centre of Research Excellence in Nutrition and Metabolism

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 avril 2017

Achèvement primaire (Réel)

15 juillet 2017

Achèvement de l'étude (Réel)

15 juillet 2017

Dates d'inscription aux études

Première soumission

17 juillet 2017

Première soumission répondant aux critères de contrôle qualité

21 juillet 2017

Première publication (Réel)

24 juillet 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juillet 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 juillet 2017

Dernière vérification

1 juillet 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EO120/2017

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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