Walnut Intervention on Metabolic Syndrome (WIMS)

NCT ID: NCT00742742

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-12-31

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).

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.

Conditions

Metabolic Syndrome X

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Nutrition advice (accroding to AHA recommendation) + 30 grams/day supplement of walnuts,walnuts were incorpatated into bread that provided to the participants

Group Type: EXPERIMENTAL

healthy life style education

Intervention Type: BEHAVIORAL

healthy life style education

B

Registed dietians give the advice for health lyfestyle

Group Type: SHAM_COMPARATOR

healthy life style education

Intervention Type: BEHAVIORAL

healthy life style education

Interventions

healthy life style education

healthy life style education

Intervention Type: BEHAVIORAL

Other Intervention Names

Dietians provided healthy lifestyle education accroding to; AHA recommendation

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Walnut Commission

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xu Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Locations

Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 20826632 (View on PubMed)

Other Identifiers

KSCX1-YW-02

Identifier Type: -

Identifier Source: secondary_id

CWC-2008

Identifier Type: -

Identifier Source: org_study_id