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Walnut Intervention on Metabolic Syndrome (WIMS) (WIMS)

This study has been completed.
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00742742
First received: August 27, 2008
Last updated: February 4, 2015
Last verified: February 2015

August 27, 2008
February 4, 2015
March 2009
July 2009   (final data collection date for primary outcome measure)
Metabolic syndrome status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Plasma Low-density-lipoprotein (LDL) cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742742 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Total cholesterol, triglyceride, 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Walnut Intervention on Metabolic Syndrome (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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Metabolic Syndrome X
Behavioral: healthy life style education
healthy life style education
Other Names:
  • Dietians provided healthy lifestyle education accroding to
  • AHA recommendation
  • Experimental: A
    Nutrition advice (accroding to AHA recommendation) + 30 grams/day supplement of walnuts,walnuts were incorpatated into bread that provided to the participants
    Intervention: Behavioral: healthy life style education
  • Sham Comparator: B
    Registed dietians give the advice for health lyfestyle
    Intervention: Behavioral: healthy life style education
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
December 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
35 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00742742
CWC-2008, KSCX1-YW-02
No
Not Provided
Not Provided
Xu Lin, Chinese Academy of Sciences
Chinese Academy of Sciences
California Walnut Commission
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Chinese Academy of Sciences
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP