- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00603876
Efficacy of Almonds Added to Chronic Statin Therapy
May 20, 2013 updated by: Janelle Ruisinger, PharmD, University of Kansas
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Shawnee, Kansas, United States, 66217
- KU MedWest
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
Step 1 dietary counseling plus 100-110 grams of almonds daily
|
100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
|
No Intervention: 1
Step 1 dietary counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of lipid panel including subfractions and Lp(a) and almond adherence
Time Frame: Once a month
|
Once a month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of height, weight, waist circumference, blood pressure and physical activity
Time Frame: Once a month
|
Once a month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Janelle Ruisinger, Pharm.D., University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
January 16, 2008
First Submitted That Met QC Criteria
January 28, 2008
First Posted (Estimate)
January 29, 2008
Study Record Updates
Last Update Posted (Estimate)
May 22, 2013
Last Update Submitted That Met QC Criteria
May 20, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KU FY08 GRF
- 10998
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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