HyperlipidemiaPhase 4NCT00603876
Efficacy of Almonds Added to Chronic Statin Therapy
A Phase 4 study testing Almonds in people with Hyperlipidemia, run by University of Kansas at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Almonds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
KU MedWest
Shawnee, Kansas, 66217
About this study
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.
Read the 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.
- Conditions
- Hyperlipidemia
- Being tested
- Almonds
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsDietary supplement
100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Step 1 dietary counseling plus 100-110 grams of almonds daily Receives: Dietary Supplement: Almonds |
| 1 | No intervention | Step 1 dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of lipid panel including subfractions and Lp(a) and almond adherence
Measured: Once a month
Secondary outcomes (1)
Measurement of height, weight, waist circumference, blood pressure and physical activity
Measured: Once a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Janelle Ruisinger, PharmD, University of Kansas
- Investigators
- Janelle Ruisinger, Pharm.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603876
- Sponsor's protocol ID
- KU FY08 GRF
- Other IDs
- 10998
- Status last verified
- May 2013
- First submitted
- 16 Jan 2008
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25670361
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Almonds Added to Chronic Statin Therapy
- ClinicalTrials.gov ID
- NCT00603876
- Acronym / sponsor ID
- KU FY08 GRF
- Conditions
- Hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Dietary Supplement: AlmondsStep 1 dietary counseling plus 100-110 grams of almonds daily |
| 1 | No intervention | –Step 1 dietary counseling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almonds100-110 grams (about 3/4 cupful)of almonds consumed daily for 28 days | Dietary supplement | 2 |
Primary outcome
Measure of lipid panel including subfractions and Lp(a) and almond adherence
Time frame: Once a month
1 secondary outcome
Measurement of height, weight, waist circumference, blood pressure and physical activity
Time frame: Once a month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
- Derived from this study: PubMed 25670361Ruisinger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janelle Ruisinger, Pharm.D. principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Almonds in people with Hyperlipidemia, run by University of Kansas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of lipid panel including subfractions and Lp(a) and almond adherence (time frame: Once a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.