Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome
Effects of Daily Walnut Intake Among the Subjects With Metabolic Syndrome in South Korea
Investigators planed to conduct a randomized, controlled, crossover trial to examine the effects of daily walnuts intake among Korean subjects with metabolic syndrome. Primary objective of this study was to investigate the effects of daily walnut intake on changes of metabolic syndrome indices in Koreans with metabolic syndrome age over 30 years old. This study was consisted of four periods: run-in, first intervention, wash-out, and second intervention phases. As 16 weeks of first intervention period began after the run-in phase, the subjects were randomly assigned into one of two groups: walnut group and control group. Participants in walnut group consumed 45 grams of walnuts on a daily basis and participants in control group were provided iso-caloric white bread for first 16 weeks. After the first intervention and wash-out period (6 weeks), second intervention which is crossover of first intervention was started during the next 16 weeks. Anthropometric measurements and biochemical analyses were done at the beginning and the end of each intervention (0, 16, 22, and 38 weeks of trial). Habitual diet was randomly observed using 3-day diet record once during each phase.
Investigators expected to evaluate 1)effects of walnut ingestion on reverting metabolic syndrome to normal status especially by reducing waist circumference and improving serum levels of triglyceride and high-density lipoprotein, 2)beneficial effects of daily walnut consumption on changes of body composition in the subjects with metabolic syndrome, and 3)regulatory effects of daily walnut intake on inflammatory markers and diabetic markers.
Descripción general del estudio
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 07327
- ICAN Nutrition Education and Research
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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: at least three out of five metabolic syndrome components
- waist circumference (WC) >90 cm for men and >80 cm for women
- hypertension (DBP ≥85 and <110 mm Hg)
- hyperglycemia (≥100 mg/dL)
- elevated plasma TG concentrations (≥150 mg/dL)
- decreased plasma HDL-C concentrations (<40 mg/dL for men and <50 mg/dL for women)
Exclusion Criteria:
- the presence of morbid obesity (BMI ≥40)
- the use of any medication for the control of blood pressure, glucose, or lipid metabolism
- a medical history of hypocaloric diet consumption within the past year
- gastrointestinal tract disorders
- post-menopausal women
- smokers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Walnut-Control
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45 g of walnut / iso-caloric white bread
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Experimental: Control-Walnut
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45 g of walnut / iso-caloric white bread
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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 of waist circumference
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Waist circumferences (cm) were obtained at the midpoint between the lowest rib and the iliac crest and rounded to the nearest 0.1 cm after inhalation and exhalation.
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after 16 weeks of daily walnut consumption
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changes of blood triglyceride level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Serum triglycerides (mg/dL) levels were measured by an enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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changes of blood high-density lipoprotein cholesterol levels
Periodo de tiempo: after 16 weeks of daily walnut consumption
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High density lipoprotein cholesterol (mg/dL) levels were determined by a homogeneous enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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changes of blood pressure
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Blood pressure (mmHg) was measured on the right arm using an up-load blood pressure monitor with participants in a comfortably seated position after at least a 5-minute rest.
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after 16 weeks of daily walnut consumption
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changes of blood glucose level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Blood glucose levels (mg/dL) were measured using blood glucose monitor and test stripts from the finger tip.
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after 16 weeks of daily walnut consumption
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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changes of total cholesterol level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Serum total cholesterol levels (ml/dL) were measured by an enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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changes of serum apolipoprotein B level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Serum apolipoprotein B (ml/dL) was measured using a turbidimetric immunoassay.
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after 16 weeks of daily walnut consumption
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changes of serum adiponectin level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Blood adiponectin (ug/mL) levels were measured using ELISA.
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after 16 weeks of daily walnut consumption
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changes of serum leptin level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Blood leptin (ug/mL) levels were measured using ELISA.
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after 16 weeks of daily walnut consumption
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changes of serum insulin level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Serum insulin (μU/mL) was measured with a commercially available kit, the ultrasensitive insulin ELISA kit using an Epoch microplate spectrophotometer.
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after 16 weeks of daily walnut consumption
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changes of low-density lipoprotein cholesterol level
Periodo de tiempo: after 16 weeks of daily walnut consumption
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Low-density lipoprotein cholesterol levels (ml/dL) were determined by a homogeneous enzymatic-colorimetric method.
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after 16 weeks of daily walnut consumption
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CWC-2016-MetS
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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