Dietary Intake of Whole Walnuts in Adult Subjects Under Low Cardiovascular Risk (FitALA)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Belgrade, Serbia, 11000
- Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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. |
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.
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Sin intervención: Control
At the beginning of the study, subjects are randomly assigned to receive either intervention treatment (whole walnuts) or no treatment (control arm).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in LDL-cholesterol
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in LDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in Systolic Blood Pressure
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in Systolic Blood Pressure, from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in Diastolic Blood Pressure
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in Diastolic Blood Pressure from baseline to endpoint, measured office-based at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in HDL-cholesterol
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in HDL-cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in total cholesterol
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in total cholesterol measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in triglycerides
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in triglycerides measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in glucose metabolism biomarkers
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in glucose biomarkers measured by clinical bio-analyzer from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in renal function parameters
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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.
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Baseline, 5 weeks, 10 weeks
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Changes in liver function parameters
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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.
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Baseline, 5 weeks, 10 weeks
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Changes in body weight
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in body weight measured by bio-impedance analyzer, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in waist circumference
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in waist circumference, from baseline to endpoint, measured at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in percent of total body fat
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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.
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Baseline, 5 weeks, 10 weeks
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Level of Physical Activity
Periodo de tiempo: Baseline
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Level of physical activity is assessed by use of standardized Physical Activity Questionnaire.
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Baseline
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Psychological parameters
Periodo de tiempo: 5 weeks
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Psychological parameters are assessed by use of standardized questionnaire for self-assessment of psychological implications of daily activities related to cardiovascular health .
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5 weeks
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Changes in hematological parameters
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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Changes in hematological, from baseline to endpoint, measured by hematological clinical analyzer at the following timepoints: 0 (baseline), 5 and 10 weeks.
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Baseline, 5 weeks, 10 weeks
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Changes in number of leukocyte cells
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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.
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Baseline, 5 weeks, 10 weeks
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Changes in total caloric intake
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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
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Changes in caloric intake of fats
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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
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Changes in caloric intake of carbohydrates
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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
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Changes in caloric intake of vitamin D
Periodo de tiempo: Baseline, 5 weeks, 10 weeks
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maria Glibetic, Prof, Center of Research Excellence in Nutrition and Metabolism, Institute for Medical Resaerch
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EO120/2017
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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