Trial | NCT00603876  Report issue

Official Title

Efficacy of Almonds Added to Chronic Statin Therapy

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    almond ...

  • Study Participants

    50
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.
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 Started
Jul 31
2008
Primary Completion
Dec 31
2012
Study Completion
Dec 31
2012
Last Update
May 22
2013
Estimate

Dietary Supplement Almonds

100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days

2 Experimental

Step 1 dietary counseling plus 100-110 grams of almonds daily

1 No Intervention

Step 1 dietary counseling

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
No Results Posted