Abstract
ObjectiveAlmonds reduce cardiovascular disease risk via cholesterol reduction, anti-inflammation, glucoregulation, and antioxidation. The objective of this randomized, controlled, cross-over trial was to determine whether the addition of 85 g almonds daily to a National Cholesterol Education Program (NCEP) Step 1 diet (ALM) for 6 weeks would improve vascular function and inflammation in patients with coronary artery disease (CAD).Research design and methodsA randomized, controlled, crossover trial was conducted in Boston, MA to test whether as compared to a control NCEP Step 1 diet absent nuts (CON), incorporation of almonds (85 g/day) into the CON diet (ALM) would improve vascular function and inflammation. The study duration was 22 weeks including a 6-weeks run-in period, two 6-weeks intervention phases, and a 4-weeks washout period between the intervention phases. A total of 45 CAD patients (27 F/18 M, 45–77 y, BMI = 20-41 kg/m2) completed the study. Drug therapies used by patients were stable throughout the duration of the trial.ResultsThe addition of almonds to the CON diet increased plasma α-tocopherol status by a mean of 5.8 %, reflecting patient compliance (P ≤0.05). However, the ALM diet did not alter vascular function assessed by measures of flow-mediated dilation, peripheral arterial tonometry, and pulse wave velocity. Further, the ALM diet did not significantly modify the serum lipid profile, blood pressure, C-reactive protein, tumor necrosis factor-α or E-selectin. The ALM diet tended to decrease vascular cell adhesion molecule-1 by 5.3 % (P = 0.064) and increase urinary nitric oxide by 17.5 % (P = 0.112). The ALM intervention improved the overall quality of the diet by increasing calcium, magnesium, choline, and fiber intakes above the Estimated Average Requirement (EAR) or Recommended Dietary Allowance (RDA).ConclusionsThus, the addition of almonds to a NECP Step 1 diet did not significantly impact vascular function, lipid profile or systematic inflammation in CAD patients receiving good medical care and polypharmacy therapies but did improve diet quality without any untoward effect.Trial registrationThe trial was registered with the ClinicalTrials.Gov with the identifier: NCT00782015.
Highlights
Coronary artery disease (CAD) is one of the most common causes of death in middle- and high-income countries [1]
The study might be underpowered for both the primary and secondary outcome measures since the power calculation was performed based on the improvement in flow-mediated dilation (FMD). This randomized, controlled, cross-over trial revealed no significant impact of the incorporation of 85 g/day almonds to a National Cholesterol Education Program (NCEP) Step 1 diet on FMD and other measures of vascular reactivity
Compliance to the almond intervention was good, as confirmed by an elevation of α-tocopherol status, and was associated with an improvement of dietary quality reflected by increased intakes of fiber, amino acids, the minerals calcium and magnesium, choline, and proanthocyanins
Summary
Coronary artery disease (CAD) is one of the most common causes of death in middle- and high-income countries [1]. Patients with CAD typically receive several medications as part of their treatment to protect against recurrent cardiac events and all-cause mortality. Lifestyle modifications comprised of regular participation in physical activity, diets low in fat and rich in plant foods and smoking cessation are recommended to complement polypharmacy regimens in the management of CAD patients [2]. Patients with CAD are almost always treated with a hypocholesterolemic drug, usually a statin, and provided with recommendations for lifestyle modification for secondary prevention. The American Heart Association recommends a diet rich in nuts, fruits and vegetables, and low in saturated fats for both primary and secondary prevention of CAD [7]. The Lyon Diet Heart Study was the first clinical trial to demonstrate that the Mediterranean diet is protective in the secondary prevention of CAD [8]
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