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Efficacy of Almonds Added to Chronic Statin Therapy

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ClinicalTrials.gov Identifier: NCT00603876
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : May 22, 2013
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Janelle Ruisinger, PharmD, University of Kansas

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Dietary Supplement: Almonds Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Almonds Added to Chronic Statin Therapy
Study Start Date : July 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 2
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
No Intervention: 1
Step 1 dietary counseling


Outcome Measures
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Primary Outcome Measures :
  1. Measure of lipid panel including subfractions and Lp(a) and almond adherence [ Time Frame: Once a month ]

Secondary Outcome Measures :
  1. Measurement of height, weight, waist circumference, blood pressure and physical activity [ Time Frame: Once a month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603876


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
KU MedWest
Shawnee, Kansas, United States, 66217
Sponsors and Collaborators
University of Kansas
Almond Board of California
Investigators
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Principal Investigator: Janelle Ruisinger, Pharm.D. University of Kansas Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janelle Ruisinger, PharmD, Clinical Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00603876    
Other Study ID Numbers: KU FY08 GRF
10998
First Posted: January 29, 2008    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases