Efficacy of Almonds Added to Chronic Statin Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effects of 100-110 grams of almonds (about ¾ cupful) daily on the lipoprotein profile when given to patients on a statin drug. The study will compare the effects on the lipoprotein profile to patients who eat almonds and those patients not eating almonds.

Detailed Description
-----------------
The primary objectives of this study are to determine the changes in the lipid profile [LDL-C, HDL-C, triglycerides, total cholesterol], LDL-C particle size, and the emerging risk factor Lp(a) when 100-110 g of almonds daily are added to statin therapy. Also, all subjects will receive Step I dietary counseling.

Official Title
-----------------
Efficacy of Almonds Added to Chronic Statin Therapy

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Almonds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable on current statin regimen for at least 8 weeks with plans to continue on the same dose while participating in the study Male or non-pregnant female - Women are eligible if they are surgically sterile or postmenopausal not using hormone replacement therapy (HRT) or using a stable, consistent does of HRT with intentions to continue therapy throughout the course of the study. Females of childbearing potential are eligible if using an effective form or contraception and intention to continue use through the study Mentally competent to understand study Speak and read English Able to maintain current medication regimen throughout study duration Exclusion Criteria: LDL-C levels <70mg/dL Currently taking lipid-lowering agents other than statins including niacin, bile-acid sequestrants, ezetimibe, fibrates, high-dose Omega-3 fish oils (>1500mg of combined EPA/DHA daily) and policosanol Adherence to specialized diet regimes, i.e., multiple food allergies or nut allergy, vegetarian, macrobiotic, fad or popular diets, taking diet pills, etc. Already consuming nuts more than twice a week Active liver disease or a history of liver disease Chronic disease involving, hepatic, renal or coronary artery disease Currently taking systemic steroidal drugs Dependence on alcohol (> 10 drinks per week) or illicit drugs Participation in any other clinical trial within the last 30 days Engages in moderate intensity exercise for > 30 minutes each day Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Step 1 dietary counseling plus 100-110 grams of almonds daily | Dietary Supplement: Almonds<br>* 100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days<br>|
| No Intervention: 1<br>Step 1 dietary counseling | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lipid panel including subfractions and Lp(a) and almond adherence |  | Once a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of height, weight, waist circumference, blood pressure and physical activity |  | Once a month |