Efficacy of Almonds Added to Chronic Statin Therapy

Phase 4

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Almonds

• Registration Number: NCT00603876
• Lead Sponsor: University of Kansas

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.

Study Timeline

• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Study Start: 2008-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Almonds	Step 1 dietary counseling plus 100-110 grams of almonds daily

Primary Outcome Measures

Name	Time	Method
Measure of lipid panel including subfractions and Lp(a) and almond adherence	Once a month

Secondary Outcome Measures

Name	Time	Method
Measurement of height, weight, waist circumference, blood pressure and physical activity	Once a month

Trial Locations

Locations (2)

KU MedWest; 🇺🇸 Shawnee, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States