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

Completed · Not applicable

Conditions studied: Metabolic Syndrome, Overweight, Obesity, Hypercholesterolemia

In brief

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.

Key facts

Study ID: NCT01010841
Run by: MetaProteomics LLC
People needed: 89
Starts: 2008-08-01
Expected to finish: 2010-04-01
Last updated by the study team: 2012-01-12

Who can join

Age: 20 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Medical History and Concurrent Diseases
Over the preceding 4 weeks, initiation or cessation of regular exercise
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
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
Over the preceding 4 weeks, regular use of Kaprex® or Kaprex AI® at least 3 days/week
Over the preceding 4 weeks, regular use of NSAIDs (i.e. ibuprofen, celecoxib, etc.) at least 3 days per week
Over the preceding 12 weeks, use of cholesterol lowering medications, either by prescription (statins, etc.) or over-the-counter (gugulipids, niacin, etc.)
Over the preceding 12 weeks, use of oral or injectable corticosteroids, such as prednisone
Current use of oral anticoagulants such as Coumadin or injectable anticoagulants such as Heparin or Low Molecular Weight Heparin
Use of electronic implants such as pacemakers, defibrillators, nerve stimulators
Allergy to one or more of the ingredients in the investigational products
Poorly controlled hypertension (blood pressure above 155/95)
History of significant liver or kidney disease (recent or ongoing hepatitis, cirrhosis, glomerulonephritis, dialysis treatment, etc.)
History of serious heart disease (heart attack, angina, cardiac surgery, arrhythmia, or congestive heart failure)
History of deep vein thrombosis or pulmonary embolus (blood clot to lungs)
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
History of eating disorder (anorexia nervosa or bulimia) in preceding 5 years
History of alcoholism or drug addiction in the preceding 5 years
History of serious mental illness
History of attempted suicide in past 10 years
Untreated endocrine, neurological, or infectious disorder
Diagnosis of Human Immunodeficiency Virus (HIV) or Acquired HIV (AIDS)
Current cancer or a history of cancer (except skin cancer)
Pregnancy or lactation
If female of childbearing potential, unwillingness to practice a reliable method of birth control (i.e. physical sperm barriers or hormonal therapies)

Where it is running

Mark McIntosh MD — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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