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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Seoul, Korea, republiek van, 07327
- ICAN Nutrition Education and Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Walnut-Control
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45 g of walnut / iso-caloric white bread
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Experimenteel: Control-Walnut
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45 g of walnut / iso-caloric white bread
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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changes of waist circumference
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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changes of total cholesterol level
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Publicaties en nuttige links
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Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CWC-2016-MetS
Plan Individuele Deelnemersgegevens (IPD)
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