Efficacy of Almonds Added to Chronic Statin Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

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

Group Type EXPERIMENTAL

Almonds

Intervention Type DIETARY_SUPPLEMENT

100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days

1

Step 1 dietary counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Almonds

100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No