Efficacy of Almonds Added to Chronic Statin Therapy | NCT00603876

Studies
Efficacy of Almonds Added to Chronic Statin Therapy

NCT00603876

Sponsor

University of Kansas

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Hyperlipidemia

Interventions

Almonds

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
10998

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 16, 2008

First Submission Date that Met QC Criteria

Jan 28, 2008

First Posted Date

Jan 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2013

Last Update Posted Date

May 22, 2013Estimated

Name	Class
Almond Board of California	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Experimental	Step 1 dietary counseling plus 100-110 grams of almonds daily	Dietary Supplement: Almonds
1	No Intervention	Step 1 dietary counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Almonds	Dietary Supplement	100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days	2

Measure	Description	Time Frame
Measure of lipid panel including subfractions and Lp(a) and almond adherence		Once a month

Measure	Description	Time Frame
Measurement of height, weight, waist circumference, blood pressure and physical activity		Once a month

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Janelle Ruisinger, Pharm.D.	University of Kansas Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States
KU MedWest

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25670361	Derived	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.

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases