Efficacy of Almonds Added to Chronic Statin Therapy

Completed · Phase 4

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID

NCT00603876

Run by

University of Kansas

People needed

50

Starts

2008-07-01

Expected to finish

2012-12-01

Last updated by the study team

2013-05-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• KU MedWest — Shawnee, Kansas, United States

Full record on ClinicalTrials.gov

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