Walnut Intervention on Metabolic Syndrome (WIMS) - Full Text View

Sponsors and Collaborators:	Chinese Academy of Sciences California Walnut Commission
Information provided by:	Chinese Academy of Sciences
ClinicalTrials.gov Identifier:	NCT00742742

Purpose

The purpose of this study is to determine whether daily supplement of 30 grams walnut is effective in the treatment of metabolic syndrome (MetS).

Condition	Intervention	Phase
Metabolic Syndrome X	Dietary Supplement: walnut Behavioral: TLC diet education	Phase II Phase III

MedlinePlus related topics: Cholesterol Dietary Supplements Metabolic Syndrome

Drug Information available for: Dextrose Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effects of Walnut Supplement on Cardio-Metabolic Risk Factors in Patients With Metabolic Syndrome

Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:

Plasma Low-density-lipoprotein (LDL) cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	March 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental TLC diet education + 30 grams/day supplement of walnut	Dietary Supplement: walnut TLC diet education + 30 grams/day supplement of walnut for 12 weeks
B: Sham Comparator TLC diet education	Behavioral: TLC diet education TLC diet 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 IDF 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.

Eligibility

Ages Eligible for Study:	35 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The International Diabetes Federation (IDF) criteria for the diagnosis of the MetS will be used. MetS will be defined with central obesity (defined as waist circumference ≥ 80 cm for women or ≥ 90 cm for men) plus any two of the following four factors:
- Raised triglycerides level: ≥ 150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality;
- Reduced HDL cholesterol: < 40 mg/dL (1.0 mmol/L) in males and < 50 mg/dL (1.3 mmol/L) in females, or specific treatment for this lipid abnormality;
- Elevated blood pressure (BP): systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg, or treatment of previously diagnosed hypertension;
- Increased fasting plasma glucose (FPG): ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742742

Contacts

Contact: An Pan, MSc	+86-21-54920910	apan@sibs.ac.cn
Contact: Ling Lu, MSc	+86-21-54920910	llu01@sibs.ac.cn

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

More Information

Institute for Nutritional Sciences, Chinese Academy of Sciences This link exits the ClinicalTrials.gov site

Responsible Party:	Institute for Nutritional Sciences, Chinese Academy of Sciences ( Xu Lin, Principal Investigator )
Study ID Numbers:	CWC-2008, KSCX1-YW-02
Study First Received:	August 27, 2008
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00742742
Health Authority:	China: Ethics Committee

Keywords provided by Chinese Academy of Sciences:

Walnut
Lipids
Blood Glucose

Study placed in the following topic categories:

Hyperinsulinism
Metabolic Diseases
Metabolic Syndrome X
Syndrome X

Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009