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Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes (WALNUT)

This study has been completed.
Sponsor:
Collaborator:
California Walnut Commission
Information provided by:
Griffin Hospital
ClinicalTrials.gov Identifier:
NCT00901043
First received: May 12, 2009
Last updated: June 16, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to examine the effects of sustained walnut consumption on endothelial function and lipid markers in patients with Type 2 diabetes mellitus.


Condition Intervention
Diabetes Mellitus Type 2
Dietary Supplement: Walnut supplementation
Dietary Supplement: No walnut supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross-Over Trial

Resource links provided by NLM:


Further study details as provided by Griffin Hospital:

Primary Outcome Measures:
  • Brachial artery flow mediated dilation (FMD) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in weight, waist circumference, blood pressure, fasting lipids, fasting insulin, HBA1c and glucose levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Walnut supplementation
Eight weeks with walnut supplementation to an ad lib diet
Dietary Supplement: Walnut supplementation
Eight weeks of walnut supplementation
Active Comparator: 2
Eight weeks ad lib diet without walnut supplementation
Dietary Supplement: No walnut supplementation
Eight weeks without walnut supplementation

Detailed Description:

Evidence-based guidelines for the management of type 2 diabetes mellitus and related CVD refer to cardioprotective dietary fatty acid proportions. Several studies demonstrate the hypocholesteremic effects of walnuts in energy restricted diets. To our knowledge, the health benefits accrued as a result of addition of walnuts to an ad libitum diet in type 2 diabetic subjects have not been studied. Addition of walnuts to an ad libitum diet represents a practical way to achieve the recommended fatty acid proportions. The proposed study will examine whether a total dietary pattern inclusive of walnuts, will result in amelioration of cardiac risk as measured by improvement in endothelial function and glycemic control in type 2 diabetics. Results of the study will have important implications for clinicians and dietitians in dietary management of type 2 diabetes. Demonstrating that walnuts can be regarded as beneficial components of dietary management of type 2 diabetes is of relevance to the walnut industry as well. The study employs a pragmatic approach to approximate dietary practices in a real world setting thus enhancing the external validity of the study. If positive, the study results can inform future marketing efforts of the California Walnut Commission. Demonstrating that addition of walnuts to an ad libitum diet can potentially lead to improvement in endothelial function, improve lipid profiles, glycemic control and reduce the risk of CVD complications in diabetic patients has important applications for dietary management of diabetes.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. men and women ages 35-75
  2. non-smoker
  3. able to have blood pressure taken bilaterally
  4. diagnosed with type 2 diabetes by physician for at least one year
  5. stable glucose levels and medication dose for the past 3 months
  6. not on insulin therapy

Exclusion Criteria:

  1. failure to meet inclusion criteria
  2. anticipated inability to complete or comply with study protocol for any reason (e.g., inability to communicate in English, dementia) or any unstable medical condition that would limit the ability of a subject to participate fully in the trial (e.g., wasting illness, AIDS, tuberculosis, psychotic disorder)
  3. diagnosed eating disorder
  4. use of lipid-lowering or antihypertensive medications (statins, red rice yeast extract, garlic) unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning, vasoactive medication (i.e., glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutriceuticals
  5. regular use of multivitamins and/or complementary or alternative supplement therapy and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
  6. any rheumatologic disease requiring regular use of NSAIDs or alternative medications
  7. regular use of fiber supplements
  8. preexisting cardiovascular disease, including symptomatic coronary artery disease (CAD), myocardial infarction, angina pectoris, anginal equivalent, peripheral vascular disease (claudication, amputation, or revascularization) congestive heart failure, carotid stenosis, aortic stenosis or stroke; diabetes, sleep apnea, severe uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 105 mmHg)
  9. coagulopathy, known bleeding diathesis or history of clinically significant hemorrhage; current use of warfarin
  10. clinically significant anemia (Hct < 36% in men, < 33% in women)
  11. intestinal or stomach disease
  12. inability to use right or left arm for endothelial function testing for any reason such as breast surgery, trauma, radiation to right axilla, lymphedema, right arm shunt, severe vascular disease in right arm
  13. subjects on a disease specific diet
  14. subjects on a weight control diet
  15. subjects on a vegan diet
  16. allergy to any kind of nut, including walnuts and peanuts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901043

Locations
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
California Walnut Commission
Investigators
Principal Investigator: DAVID L KATZ, MD YALE-GRIFFIN PREVENTION RESEARCH CENTER
  More Information

No publications provided

Responsible Party: David Katz, MD, Yale-Griffin Prevention Research Center
ClinicalTrials.gov Identifier: NCT00901043     History of Changes
Other Study ID Numbers: Griffin IRB # 2007-10
Study First Received: May 12, 2009
Last Updated: June 16, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014