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Efficacy of Almonds Added to Chronic Statin Therapy
This study is currently recruiting participants.
Verified by University of Kansas, November 2008
Sponsors and Collaborators: University of Kansas
Almond Board of California
Information provided by: University of Kansas
ClinicalTrials.gov Identifier: NCT00603876
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
 Dietary Supplement: Almonds
 Phase IV

MedlinePlus related topics: Statins
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Efficacy of Almonds Added to Chronic Statin Therapy

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Measure of lipid panel including subfractions and Lp(a) and almond adherence [ Time Frame: Once a month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of height, weight, waist circumference, blood pressure and physical activity [ Time Frame: Once a month ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Experimental
Step 1 dietary counseling plus 100-110 grams of almonds daily
Dietary Supplement: Almonds
100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
1: No Intervention
Step 1 dietary counseling

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603876

Contacts
Contact: Janelle Ruisinger, Pharm.D. (913) 588-2608 jruisinger@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Janelle Ruisinger, Pharm.D.     913-588-2608     jruisinger@kumc.edu    
Principal Investigator: Janelle Ruisinger, Pharm.D.            
KU MedWest Recruiting
Shawnee, Kansas, United States, 66217
Contact: Janelle Ruisinger, Pharm.D.     913-588-8526     jruisinger@kumc.edu    
Principal Investigator: Janelle Ruisinger, Pharm.D.            
Sponsors and Collaborators
University of Kansas
Almond Board of California
Investigators
Principal Investigator: Janelle Ruisinger, Pharm.D. University of Kansas
  More Information

Responsible Party: University of Kansas Medical Center ( Janelle Ruisinger, Pharm.D. )
Study ID Numbers: KU FY08 GRF, 10998
Study First Received: January 16, 2008
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00603876  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009



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