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

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

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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 |
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

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
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 | |
KU MedWest | |
Shawnee, Kansas, United States, 66217 |
Principal Investigator: | Janelle Ruisinger, Pharm.D. | University of Kansas Medical Center |
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 |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |