Walnut Intervention on Metabolic Syndrome (WIMS) (WIMS)

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).

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Behavioral: healthy life style education

Detailed Description

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-ATPⅢ 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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200031
    • Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• With metabolic syndrome. Metabolic syndrome was defined based upon the updated National Cholesterol Education Program Adult Treatment Panel III criteria for Asian-Americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) HDL cholesterol <1.03 for men or <1.30 for women; 4) blood pressure ≥130/85 mmHg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin.
• Being able to comply with the specified feeding conditions
• Being able to eat walnuts
• Being between the ages of 35 and 60 years

Exclusion Criteria:

• Pregnancy or lactation
• Use of insulin
• Severe kidney disease
• Cardiovascular diseases, stroke, cancer and psychological disorders
• Walnut allergies or frequently eating walnuts or other nuts (>90 grams/week)
• Drug or alcohol abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Nutrition advice (accroding to AHA recommendation) + 30 grams/day supplement of walnuts,walnuts were incorpatated into bread that provided to the participants	Behavioral: healthy life style education; healthy life style education; Other Names: Dietians provided healthy lifestyle education accroding to; AHA recommendation
Sham Comparator: B; Registed dietians give the advice for health lyfestyle	Behavioral: healthy life style education; healthy life style education; Other Names: Dietians provided healthy lifestyle education accroding to; AHA recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic syndrome status	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Total cholesterol, triglyceride, LDL_C HDL-C, fasting glucose and insulin, HbA1C, blood pressure, CRP, IL-6, adiponectin, RBP4, E-selectin, ICAM-1, VCAM-1, and fatty acid profiles of the red blood cells.	12 weeks

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: California Walnut Commission

Publications and helpful links

General Publications

• Wu H, Pan A, Yu Z, Qi Q, Lu L, Zhang G, Yu D, Zong G, Zhou Y, Chen X, Tang L, Feng Y, Zhou H, Chen X, Li H, Demark-Wahnefried W, Hu FB, Lin X. Lifestyle counseling and supplementation with flaxseed or walnuts influence the management of metabolic syndrome. J Nutr. 2010 Nov;140(11):1937-42. doi: 10.3945/jn.110.126300. Epub 2010 Sep 8.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 27, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Lipids; Blood Glucose; Walnut
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CWC-2008; KSCX1-YW-02