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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: UltraMealPlus 360 (Medical food)
  • Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
• Other: Low-glycemic-load diet
  • Modified Mediterranean-style low-glycemic-load diet

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Low-glycemic-load diet
  • Modified Mediterranean-style low-glycemic-load diet
• Experimental: Low-glycemic-load diet + medical food
  • Modified Mediterranean-style, low-glycemic-load diet + medical food

Primary Measures

• TG-to-HDL ratio
  • Time Frame: Baseline, 8 weeks, 12 weeks
    Safety Issue?: No

Secondary Measures

• Components of metabolic syndrome (TG, HDL, resolution of MetS)
  • Time Frame: Baseline, 8 weeks, 12 weeks
    Safety Issue?: No
• Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
  • Time Frame: Baseline, 8 weeks, 12 weeks
    Safety Issue?: No
• 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
    Safety Issue?: No
• Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
  • Time Frame: Baseline, 8 weeks, 12 weeks
    Safety Issue?: No
• Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)
  • Time Frame: Baseline, 8 weeks, 12 weeks
    Safety Issue?: No
• Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
  • Time Frame: baseline, then every 2 weeks
    Safety Issue?: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Medical History and Concurrent Diseases
• 1. Over the preceding 4 weeks, initiation or cessation of regular exercise
• 2. 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
• 3. 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
• 4. Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
• 5. Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
• 6. Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
• 7. Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
• 8. Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
• 9. Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
• 10. Allergy to one or more of the ingredients in the investigational products
• 11. Poorly controlled hypertension (blood pressure above 155/95)
• 12. History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
• 13. History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
• 14. History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
• 15. 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
• 16. History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
• 17. History of alcoholism or drug addiction in the preceding 5 years
• 18. History of serious mental illness
• 19. History of attempted suicide in past 10 years
• 20. Untreated endocrine, neurological, or infectious disorder
• 21. Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
• 22. Current cancer or a history of cancer (except skin cancer)
• 23. Pregnancy or lactation
• 24. If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)
• 25. Any other sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI).
• Physical and Laboratory Test Findings
• 1. TG ≥ 400 mg/dl
• 2. abnormal blood count (Hct < 30 or > 47%, WBC < 3,000 or > 12,000, platelets <140 or > 500)
• 3. 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)
• 4. fasting glucose >150 mg/dL, serum calcium (>10.5 mg/dL), positive pregnancy test (ß-hCG in blood)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MetaProteomics LLC

Overall Clinical Trial Officials and Contacts

Robert H Lerman, MD/PhD Study Director MetaProteomics LLC  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010841

Study ID Number: HMS4-MUL-CT

ClinicalTrials.gov Identifier: NCT01010841

Health Authority: United States: Institutional Review Board