Metabolic Syndrome X Clinical Trial
Official title:
The Effects of Walnut Supplement on Cardio-Metabolic Risk Factors in Patients With Metabolic Syndrome
The purpose of this study is to determine whether a daily supplement of 30 grams of walnut is effective in the treatment of metabolic syndrome (MetS).
Metabolic syndrome (MetS), a constellation of metabolic abnormalities including central
obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the
development of type 2 diabetes and CVD. It has become one of the major public health
challenges in China due to rapidly nutrition transition and the nature of obesity epidemic.
Treatment of MetS in China is very important for the prevention of the epidemic of its
consequences (such as CVD and type 2 diabetes).
Compelling evidence from recent human studies has demonstrated that diet and lifestyle
modifications are effective means in MetS management. Walnut is a complex food source
containing high amounts of polyunsaturated fatty acids (PUFA), as well as plant protein,
Vitamin E and other substances that may have an impact on health. Therefore, the aim of this
study is to investigate the effect of walnut supplementation on the management of MetS in
adult Chinese men and women in a randomized, controlled clinical trial. A total of 200
participants with MetS (defined by NCEP-ATPâ…˘ criteria) will be randomly assigned to a
walnut-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. Effects
of walnut supplementation will be evaluated by measuring metabolic profile (BMI, blood
pressure, total cholesterol, triglyceride, LDL-C and HDL-C, fasting glucose and insulin,
HbA1C), inflammatory markers (CRP and IL-6), markers of endothelial function (E-selectin,
ICAM-1 and VCAM-1), and fatty acid profile.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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