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Walnut Intervention on Metabolic Syndrome (WIMS) (WIMS)

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ClinicalTrials.gov Identifier: NCT00742742
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : February 5, 2015
Sponsor:
Collaborator:
California Walnut Commission
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Metabolic Syndrome X Behavioral: healthy life style education Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Walnut Supplement on Cardio-Metabolic Risk Factors in Patients With Metabolic Syndrome
Study Start Date : March 2009
Primary Completion Date : July 2009
Study Completion Date : December 2009


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



Primary Outcome Measures :
  1. Metabolic syndrome status [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742742


Locations
China
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
California Walnut Commission
Investigators
Principal Investigator: Xu Lin, MD, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT00742742     History of Changes
Other Study ID Numbers: CWC-2008
KSCX1-YW-02
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Xu Lin, Chinese Academy of Sciences:
Walnut
Lipids
Blood Glucose

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases