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

January 11, 2012 updated by: MetaProteomics LLC

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Mark McIntosh MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Low-glycemic-load diet
Modified Mediterranean-style low-glycemic-load diet
Dietary supplement: UltraMealPlus 360 (Medical food)
Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
Other Names:
  • UltraMealPlus 360

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TG-to-HDL ratio
Time Frame: Baseline, 8 weeks, 12 weeks
Baseline, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Components of metabolic syndrome (TG, HDL, resolution of MetS)
Time Frame: Baseline, 8 weeks, 12 weeks
Baseline, 8 weeks, 12 weeks
Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
Time Frame: Baseline, 8 weeks, 12 weeks
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
Baseline, 8 weeks, 12 weeks
Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
Time Frame: Baseline, 8 weeks, 12 weeks
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
Baseline, 8 weeks, 12 weeks
Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
Time Frame: baseline, then every 2 weeks
baseline, then every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetaProteomics LLC

Collaborators

University of Florida
University of California, Irvine
University of Connecticut

Investigators

  • Principal Investigator: Maria Luz Fernandez, PhD, University of Connecticut
  • Study Director: Robert H Lerman, MD/PhD, MetaProteomics LLC
  • Principal Investigator: Mark McIntosh, MD, University of Florida
  • Principal Investigator: Wadie Najm, PhD, University of California at Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (Estimate)

November 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMS4-MUL-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Low-glycemic-load diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe