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Efficacy of Almonds Added to Chronic Statin Therapy

Primary Purpose

Hyperlipidemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Almonds
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center
  • KU MedWest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

2

1

Arm Description

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

Step 1 dietary counseling

Outcomes

Primary Outcome Measures

Measure of lipid panel including subfractions and Lp(a) and almond adherence

Secondary Outcome Measures

Measurement of height, weight, waist circumference, blood pressure and physical activity

Full Information

First Posted
January 16, 2008
Last Updated
May 20, 2013
Sponsor
University of Kansas
Collaborators
Almond Board of California
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1. Study Identification

Unique Protocol Identification Number
NCT00603876
Brief Title
Efficacy of Almonds Added to Chronic Statin Therapy
Official Title
Efficacy of Almonds Added to Chronic Statin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas
Collaborators
Almond Board of California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Step 1 dietary counseling plus 100-110 grams of almonds daily
Arm Title
1
Arm Type
No Intervention
Arm Description
Step 1 dietary counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
Almonds
Intervention Description
100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
Primary Outcome Measure Information:
Title
Measure of lipid panel including subfractions and Lp(a) and almond adherence
Time Frame
Once a month
Secondary Outcome Measure Information:
Title
Measurement of height, weight, waist circumference, blood pressure and physical activity
Time Frame
Once a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janelle Ruisinger, Pharm.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
KU MedWest
City
Shawnee
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25670361
Citation
Ruisinger JF, Gibson CA, Backes JM, Smith BK, Sullivan DK, Moriarty PM, Kris-Etherton P. Statins and almonds to lower lipoproteins (the STALL Study). J Clin Lipidol. 2015 Jan-Feb;9(1):58-64. doi: 10.1016/j.jacl.2014.10.001. Epub 2014 Oct 13.
Results Reference
derived

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Efficacy of Almonds Added to Chronic Statin Therapy

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