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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01010841
• Date of registration: 06/11/2009
• Primary sponsor: MetaProteomics LLC
• Public title: Trial of Two Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome HMS4
• Scientific title: Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
• Date of first enrolment: August 2008
• Target sample size: 89
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01010841
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Robert H Lerman, MD/PhD
• Affiliation: MetaProteomics LLC

• Name: Wadie Najm, PhD
• Affiliation: University of California at Irvine

• Name: Maria Luz Fernandez, PhD
• Affiliation: University of Connecticut

• Name: Mark McIntosh, MD
• Affiliation: University of Florida

Key inclusion & exclusion 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)



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Metabolic Syndrome

Obesity

Overweight

Intervention(s)

Dietary Supplement: UltraMealPlus 360 (Medical food)

Other: Low-glycemic-load diet

Primary Outcome(s)

TG-to-HDL ratio [Time Frame: Baseline, 8 weeks, 12 weeks]

Secondary Outcome(s)

Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning) [Time Frame: Baseline, 8 weeks, 12 weeks]

Components of metabolic syndrome (TG, HDL, resolution of MetS) [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]

Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score) [Time Frame: Baseline, 8 weeks, 12 weeks]

Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1) [Time Frame: Baseline, 8 weeks, 12 weeks]

Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires) [Time Frame: baseline, then every 2 weeks]

Secondary ID(s)

HMS4-MUL-CT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of California, Irvine

University of Connecticut

University of Florida