Efficacy of Almonds Added to Chronic Statin Therapy

Hyperlipidemia Clinical Trial

Official title:

Efficacy of Almonds Added to Chronic Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603876
• Other study ID #: KU FY08 GRF
• Secondary ID: 10998
• Status: Completed
• Phase: Phase 4
• First received: January 16, 2008
• Last updated: May 20, 2013
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias

Intervention

Dietary Supplement:
• Almonds
100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	KU MedWest	Shawnee	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of lipid panel including subfractions and Lp(a) and almond adherence		Once a month	No
Secondary	Measurement of height, weight, waist circumference, blood pressure and physical activity		Once a month	No