Efficacy of Almonds Added to Chronic Statin Therapy

Kansas Board of Regents

Status and phase

Completed

Phase 4

Conditions

Hyperlipidemia

Treatments

Dietary Supplement: Almonds

Study type

Interventional

Funder types

Other

Identifiers

NCT00603876

10998

KU FY08 GRF

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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