Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

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.

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 Investigator: MetaProteomics LLC Industry

Overall Clinical Trial Officials and Contacts

Robert H Lerman, MD/PhD Study Director MetaProteomics LLC  

Information obtained from ClinicalTrials.gov on February 09, 2012

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