DIABETES MELLITUS TYPE 2
Conditions
Brief summary
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.
Detailed description
Evidence-based guidelines for the management of type 2 diabetes mellitus and related cardiovascular disease (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.
Interventions
DIETARY_SUPPLEMENTWalnut supplementation
Eight weeks of walnut supplementation
DIETARY_SUPPLEMENTAd lib diet
Eight weeks without walnut supplementation
Sponsors
California Walnut Commission
Griffin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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 endothelial function (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 nonsteroidal antiinflammatory drug (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brachial artery flow mediated dilation (FMD) | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in weight, waist circumference, blood pressure, fasting lipids, fasting insulin, HBA1c and glucose levels | 8 weeks |
Countries
United States
Outcome results
None listed