Status:
COMPLETED
Effects of Walnuts on Central Blood Pressure, Arterial Stiffness Indices, Lipoproteins, and Other CVD Risk Factors
Lead Sponsor:
Penn State University
Collaborating Sponsors:
California Walnut Commission
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
30-65 years
Phase:
NA
Brief Summary
This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD risk factors, including central blood pressure, arterial stiffness indices, inflammatory markers, urinary isop...
Detailed Description
Diets containing nuts likely reduce cardiovascular disease (CVD) risk but the mechanisms remain poorly defined. Walnuts contain substantial amounts of polyunsaturated fatty acids (PUFAs), particularly...
Eligibility Criteria
Inclusion
- Aged 30-65 years
- BMI greater than 25 and less than or equal to 40 kg/m2
- Non-smokers
- TG \< 350 mg/dL
- LDL-C between the 25-95th percentile from NHANES:
- Males: 105-194 mg/dL
- Females: 98-190 mg/dL
- Stage I hypertension:
- SBP \> 120 mmHg and/or DBP \> 80 mmHg
- SBP \< 160 mmHg and DBP \< 100 mmHg
- Free of established CVD, stroke, diabetes, liver, kidney or autoimmune disease.
Exclusion
- Elevated BP (SBP ≥160 mmHg OR DBP ≥ 100 mmHg)
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, inflammatory disease, kidney disease, and/or thyroid disease (unless controlled on medication).
- Blood pressure or cholesterol-lowering medication use
- Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, and phytoestrogens).
- Vegetarianism or other dietary practices that are inconsistent with the test diets
- Nut allergies (Other food allergies will be reviewed on a case-by-case basis)
- Refusal to discontinue nutritional supplements, herbs, vitamins or NSAID's
- Latex allergy
- Pregnant or lactating females
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02210767
Start Date
August 1 2014
End Date
April 1 2018
Last Update
August 21 2023
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802