Metabolic SyndromeHMS4NCT01010841
Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
A study testing UltraMealPlus 360 (Medical food) and Low-glycemic-load diet in people with Metabolic Syndrome and Overweight, run by MetaProteomics LLC at 1 site in United States.
Trial summary
The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Metabolic Syndrome, Overweight, Obesity
- What is being tested?
- UltraMealPlus 360 (Medical food) and Low-glycemic-load diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Interventional
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥25 and <45
- LDL >100 mg/dl
- TG ≥150 and <400 mg/dl
- meet 2 or more of the following 4 criteria:
- HDL <50 mg/dl
- blood pressure ≥130/85 mmHg (or diagnosed hypertension on medication)
- fasting glucose ≥100 mg/dl and <150 mg/dl
- waist circumference >35 inches
Who cannot join
- Medical History and Concurrent Diseases
- Over the preceding 4 weeks, initiation or cessation of regular exercise
- Over the preceding 4 weeks, involvement in a significant diet or weight loss program such as Atkin's diet program, a very low calorie liquid program (such as Optifast, Medifast, and HMR), or any diet that has led to a weight loss of 10% of body weight over a period of 6 weeks
- Use of blood sugar lowering medications including thiazolidinedione class of oral medications including Avandia (rosiglitazone), Avandamet (metformin/rosiglitazone), Actos (pioglitazone), metformin (Glucophage, Fortamet, Riomet) or insulin over the preceding 12 weeks
- Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
- Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
Show all 31Show fewer
- Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
- Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
- Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
- Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
- Allergy to one or more of the ingredients in the investigational products
- Poorly controlled hypertension (blood pressure above 155/95)
- History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
- History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
- History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
- History of autoimmune diseases such as inflammatory bowel disease (Crohn's disease, and/or ulcerative colitis), multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, polymyositis, scleroderma and thyroiditis
- History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
- History of alcoholism or drug addiction in the preceding 5 years
- History of serious mental illness
- History of attempted suicide in past 10 years
- Untreated endocrine, neurological, or infectious disorder
- Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
- Current cancer or a history of cancer (except skin cancer)
- Pregnancy or lactation
- If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)
- Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI).
- Physical and Laboratory Test Findings
- TG ≥ 400 mg/dl
- abnormal blood count (Hct < 30 or > 47%, WBC < 3,000 or > 12,000, platelets <140 or > 500)
- abnormal kidney function test(s) (BUN > 30 mg/dL or creatinine > 1.5 mg/dL) or liver function test(s) (bilirubin total > 2.0 mg/dL, ALT > 75 IU/L, AST > 75 IU/L; Alk Phos > 130 IU)
- fasting glucose >150 mg/dL, serum calcium (>10.5 mg/dL), positive pregnancy test (ß-hCG in blood)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome.
Read the detailed description
As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that specific phytochemical supplementation for 12 weeks (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins) increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD in subjects with metabolic syndrome and elevated LDL cholesterol. In this study, we propose to conduct a multi-center randomized trial to confirm our previous findings.
- Conditions
- Metabolic Syndrome, Overweight, Obesity, Hypercholesterolemia
- Being tested
- UltraMealPlus 360 (Medical food), Low-glycemic-load diet
- Keywords
- Metabolic syndrome, Serum lipid, Dietary intervention, Lifestyle modification, Glycemic load, Phytochemical, Hops, Acacia, Mediterranean diet, Kinase modulator
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraMealPlus 360 (Medical food)Dietary supplement
Also called UltraMealPlus 360
Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
Low-glycemic-load dietOther
Modified Mediterranean-style low-glycemic-load diet
| Study group | Role | What they receive |
|---|---|---|
| Low-glycemic-load diet | Active comparator | Modified Mediterranean-style low-glycemic-load diet Receives: Other: Low-glycemic-load diet |
| Low-glycemic-load diet + medical food | Experimental | Modified Mediterranean-style, low-glycemic-load diet + medical food Receives: Dietary Supplement: UltraMealPlus 360 (Medical food); Other: Low-glycemic-load diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
TG-to-HDL ratio
Measured: Baseline, 8 weeks, 12 weeks
Secondary outcomes (6)
Components of metabolic syndrome (TG, HDL, resolution of MetS)
Measured: Baseline, 8 weeks, 12 weeks
Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
Measured: Baseline, 8 weeks, 12 weeks
CVD risk factors (cholesterol, LDL, chol/HDL, apoAI, apoB, apoAII, apoCII, apoCIII, apoE, homocysteine, RBC fatty acids, Framingham risk score)
Measured: Baseline, 8 weeks, 12 weeks
Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
Measured: Baseline, 8 weeks, 12 weeks
Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)
Measured: Baseline, 8 weeks, 12 weeks
Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
Measured: baseline, then every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetaProteomics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida, University of Connecticut, University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Robert H Lerman, MD/PhD, Study director, MetaProteomics LLCMark McIntosh, MD, Principal investigator, University of FloridaMaria Luz Fernandez, PhD, Principal investigator, University of ConnecticutWadie Najm, PhD, Principal investigator, University of California at Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010841
- Sponsor's protocol ID
- HMS4-MUL-CT
- Acronym
- HMS4
- Status last verified
- Jan 2012
- First submitted
- 6 Nov 2009
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones JL, Fernandez ML, McIntosh MS, Najm W, Calle MC, Kalynych C, Vukich C, Barona J, Ackermann D, Kim JE, Kumar V, Lott M, Volek JS, Lerman RH. A Mediterranean-style low-glycemic-load diet improves variables of metabolic syndrome in women, and addition of a phytochemical-rich medical food enhances benefits on lipoprotein metabolism. J Clin Lipidol. 2011 May-Jun;5(3):188-196. doi: 10.1016/j.jacl.2011.03.002. Epub 2011 Mar 11.
PubMed 21600524Fernandez ML, Jones JJ, Ackerman D, Barona J, Calle M, Comperatore MV, Kim JE, Andersen C, Leite JO, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH. Low HDL cholesterol is associated with increased atherogenic lipoproteins and insulin resistance in women classified with metabolic syndrome. Nutr Res Pract. 2010 Dec;4(6):492-8. doi: 10.4162/nrp.2010.4.6.492. Epub 2010 Dec 28.
PubMed 21286407Ackermann D, Jones J, Barona J, Calle MC, Kim JE, LaPia B, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH, Fernandez ML. Waist circumference is positively correlated with markers of inflammation and negatively with adiponectin in women with metabolic syndrome. Nutr Res. 2011 Mar;31(3):197-204. doi: 10.1016/j.nutres.2011.02.004.
PubMed 21481713Barona J, Jones JJ, Kopec RE, Comperatore M, Andersen C, Schwartz SJ, Lerman RH, Fernandez ML. A Mediterranean-style low-glycemic-load diet increases plasma carotenoids and decreases LDL oxidation in women with metabolic syndrome. J Nutr Biochem. 2012 Jun;23(6):609-15. doi: 10.1016/j.jnutbio.2011.02.016. Epub 2011 Jul 19.
PubMed 21775117Jones JL, Comperatore M, Barona J, Calle MC, Andersen C, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet decreases atherogenic lipoproteins and reduces lipoprotein (a) and oxidized low-density lipoprotein in women with metabolic syndrome. Metabolism. 2012 Mar;61(3):366-72. doi: 10.1016/j.metabol.2011.07.013. Epub 2011 Sep 23.
PubMed 21944261Jones JL, Park Y, Lee J, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet reduces the expression of 3-hydroxy-3-methylglutaryl-coenzyme A reductase in mononuclear cells and plasma insulin in women with metabolic syndrome. Nutr Res. 2011 Sep;31(9):659-64. doi: 10.1016/j.nutres.2011.08.011.
PubMed 22024489Jones JL, Ackermann D, Barona J, Calle M, Andersen C, Kim JE, Volek JS, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean low-glycemic-load diet alone or in combination with a medical food improves insulin sensitivity and reduces inflammation in women with metabolic syndrome. British Journal of Medicine & Medical Research 1(4):356-370, 2011.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01010841
- Acronym / sponsor ID
- HMS4 / HMS4-MUL-CT
- Conditions
- Metabolic Syndrome, Overweight, Obesity, Hypercholesterolemia
- Keywords
- Metabolic syndrome, Serum lipid, Dietary intervention, Lifestyle modification, Glycemic load, Phytochemical, Hops, Acacia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- MetaProteomics LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida, University of Connecticut, University of California, Irvine
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 10 Nov 2009 (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 objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome.
Detailed description
As the worldwide dietary pattern becomes more westernized, the metabolic syndrome is reaching epidemic proportions. Lifestyle modifications including diet and exercise are recommended as first-line intervention for treating metabolic syndrome. Previously, we reported that specific phytochemical supplementation for 12 weeks (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins) increased the effectiveness of the modified Mediterranean-style low glycemic load dietary program on variables associated with metabolic syndrome and CVD in subjects with metabolic syndrome and elevated LDL cholesterol. In this study, we propose to conduct a multi-center randomized trial to confirm our previous findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-glycemic-load diet | Active comparator | Other: Low-glycemic-load dietModified Mediterranean-style low-glycemic-load diet |
| Low-glycemic-load diet + medical food | Experimental | Dietary Supplement: UltraMealPlus 360 (Medical food), Other: Low-glycemic-load dietModified Mediterranean-style, low-glycemic-load diet + medical food |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- BMI ≥25 and <45
- LDL >100 mg/dl
- TG ≥150 and <400 mg/dl
- meet 2 or more of the following 4 criteria:
Key exclusion criteria (31 listed)
- Medical History and Concurrent Diseases
- Physical and Laboratory Test Findings
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 |
|---|---|---|
| UltraMealPlus 360 (Medical food)Also: UltraMealPlus 360Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) | Dietary supplement | Low-glycemic-load diet + medical food |
| Low-glycemic-load dietModified Mediterranean-style low-glycemic-load diet | Other | Low-glycemic-load diet, Low-glycemic-load diet + medical food |
Primary outcome
TG-to-HDL ratio
Time frame: Baseline, 8 weeks, 12 weeks
6 secondary outcomes
Components of metabolic syndrome (TG, HDL, resolution of MetS)
Time frame: Baseline, 8 weeks, 12 weeks
Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
Time frame: Baseline, 8 weeks, 12 weeks
CVD risk factors (cholesterol, LDL, chol/HDL, apoAI, apoB, apoAII, apoCII, apoCIII, apoE, homocysteine, RBC fatty acids, Framingham risk score)
Time frame: Baseline, 8 weeks, 12 weeks
Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
Time frame: Baseline, 8 weeks, 12 weeks
Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)
Time frame: Baseline, 8 weeks, 12 weeks
Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
Time frame: baseline, then every 2 weeks
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 12 Jan 2012.
- Results publication: PubMed 21600524Jones JL, Fernandez ML, McIntosh MS, Najm W, Calle MC, Kalynych C, Vukich C, Barona J, Ackermann D, Kim JE, Kumar V, Lott M, Volek JS, Lerman RH. A Mediterranean-style low-glycemic-load diet improves variables of metabolic syndrome in women, and addition of a phytochemical-rich medical food enhances benefits on lipoprotein metabolism. J Clin Lipidol. 2011 May-Jun;5(3):188-196. doi: 10.1016/j.jacl.2011.03.002. Epub 2011 Mar 11.
- Results publication: PubMed 21286407Fernandez ML, Jones JJ, Ackerman D, Barona J, Calle M, Comperatore MV, Kim JE, Andersen C, Leite JO, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH. Low HDL cholesterol is associated with increased atherogenic lipoproteins and insulin resistance in women classified with metabolic syndrome. Nutr Res Pract. 2010 Dec;4(6):492-8. doi: 10.4162/nrp.2010.4.6.492. Epub 2010 Dec 28.
- Results publication: PubMed 21481713Ackermann D, Jones J, Barona J, Calle MC, Kim JE, LaPia B, Volek JS, McIntosh M, Kalynych C, Najm W, Lerman RH, Fernandez ML. Waist circumference is positively correlated with markers of inflammation and negatively with adiponectin in women with metabolic syndrome. Nutr Res. 2011 Mar;31(3):197-204. doi: 10.1016/j.nutres.2011.02.004.
- Results publication: PubMed 21775117Barona J, Jones JJ, Kopec RE, Comperatore M, Andersen C, Schwartz SJ, Lerman RH, Fernandez ML. A Mediterranean-style low-glycemic-load diet increases plasma carotenoids and decreases LDL oxidation in women with metabolic syndrome. J Nutr Biochem. 2012 Jun;23(6):609-15. doi: 10.1016/j.jnutbio.2011.02.016. Epub 2011 Jul 19.
- Results publication: PubMed 21944261Jones JL, Comperatore M, Barona J, Calle MC, Andersen C, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet decreases atherogenic lipoproteins and reduces lipoprotein (a) and oxidized low-density lipoprotein in women with metabolic syndrome. Metabolism. 2012 Mar;61(3):366-72. doi: 10.1016/j.metabol.2011.07.013. Epub 2011 Sep 23.
- Results publication: PubMed 22024489Jones JL, Park Y, Lee J, Lerman RH, Fernandez ML. A Mediterranean-style, low-glycemic-load diet reduces the expression of 3-hydroxy-3-methylglutaryl-coenzyme A reductase in mononuclear cells and plasma insulin in women with metabolic syndrome. Nutr Res. 2011 Sep;31(9):659-64. doi: 10.1016/j.nutres.2011.08.011.
- Results publicationJones JL, Ackermann D, Barona J, Calle M, Andersen C, Kim JE, Volek JS, McIntosh M, Najm W, Lerman RH, Fernandez ML. A Mediterranean low-glycemic-load diet alone or in combination with a medical food improves insulin sensitivity and reduces inflammation in women with metabolic syndrome. British Journal of Medicine & Medical Research 1(4):356-370, 2011.
Related trials for Metabolic Syndrome
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Robert H Lerman, MD/PhD study director
MetaProteomics LLC
Mark McIntosh, MD principal investigator
University of Florida
Maria Luz Fernandez, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraMealPlus 360 (Medical food) and Low-glycemic-load diet in people with Metabolic Syndrome and Overweight, run by MetaProteomics LLC at 1 site 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 8 inclusion and 31 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 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
TG-to-HDL ratio (time frame: Baseline, 8 weeks, 12 weeks). 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 NCT01010841, which also lists 7 linked publications.
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 12 Jan 2012.