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Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome (HMS4)

This study has been completed.
Sponsor:
Collaborators:
University of Florida
University of Connecticut
University of California, Irvine
Information provided by (Responsible Party):
MetaProteomics LLC
ClinicalTrials.gov Identifier:
NCT01010841
First received: November 6, 2009
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Overweight
Obesity
Hypercholesterolemia
Dietary Supplement: UltraMealPlus 360 (Medical food)
Other: Low-glycemic-load diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by MetaProteomics LLC:

Primary Outcome Measures:
  • TG-to-HDL ratio [ Time Frame: Baseline, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

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

Enrollment: 89
Study Start Date: August 2008
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-glycemic-load diet
Modified Mediterranean-style low-glycemic-load diet
Other: 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
Dietary Supplement: UltraMealPlus 360 (Medical food)
Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
Other Name: UltraMealPlus 360
Other: Low-glycemic-load diet
Modified Mediterranean-style low-glycemic-load diet

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010841

Locations
United States, Florida
Mark McIntosh MD
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
MetaProteomics LLC
University of Florida
University of Connecticut
University of California, Irvine
Investigators
Study Director: Robert H Lerman, MD/PhD MetaProteomics LLC
Principal Investigator: Mark McIntosh, MD University of Florida
Principal Investigator: Maria Luz Fernandez, PhD University of Connecticut
Principal Investigator: Wadie Najm, PhD University of California at Irvine
  More Information

Publications:

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01010841     History of Changes
Other Study ID Numbers: HMS4-MUL-CT
Study First Received: November 6, 2009
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MetaProteomics LLC:
Metabolic syndrome
Serum lipid
Dietary intervention
Lifestyle modification
Glycemic load
Phytochemical
Hops
Acacia
Mediterranean diet
Kinase modulator

Additional relevant MeSH terms:
Hypercholesterolemia
Metabolic Syndrome X
Overweight
Syndrome
Body Weight
Disease
Dyslipidemias
Glucose Metabolism Disorders
Hyperinsulinism
Hyperlipidemias
Insulin Resistance
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014