NCT00603876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

4.4 years

First QC Date

January 16, 2008

Last Update Submit

May 20, 2013

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

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

    Once a month

Secondary Outcomes (1)

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

    Once a month

Study Arms (2)

2

EXPERIMENTAL

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

Dietary Supplement: Almonds

1

NO INTERVENTION

Step 1 dietary counseling

Interventions

AlmondsDIETARY_SUPPLEMENT

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

KU MedWest

Shawnee, Kansas, 66217, United States

Location

Related Publications (1)

  • 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.

    PMID: 25670361DERIVED

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Janelle Ruisinger, Pharm.D.

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

US(2)