Efficacy of Almonds Added to Chronic Statin Therapy

This study has been completed.
Sponsor:
Collaborator:
Almond Board of California
Information provided by (Responsible Party):
Janelle Ruisinger, PharmD, University of Kansas
ClinicalTrials.gov Identifier:
NCT00603876
First received: January 16, 2008
Last updated: May 20, 2013
Last verified: May 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Almonds Added to Chronic Statin Therapy

Resource links provided by NLM:


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 ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603876

Locations
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
Principal Investigator: Janelle Ruisinger, Pharm.D. University of Kansas
  More Information

No publications provided

Responsible Party: Janelle Ruisinger, PharmD, Clinical Associate Professor, University of Kansas
ClinicalTrials.gov Identifier: NCT00603876     History of Changes
Other Study ID Numbers: KU FY08 GRF, 10998
Study First Received: January 16, 2008
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014