Multi-center, Randomized Intervention to Compare the Effects of 2 Dietary Programs on Cardiometabolic Risk Factors in Subjects With Metabolic Syndrome
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- MetaProteomics LLC
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- TG-to-HDL ratio
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
TG-to-HDL ratio
Time Frame: Baseline, 8 weeks, 12 weeks
Secondary Outcomes
- Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)(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)(Baseline, 8 weeks, 12 weeks)
- Components of metabolic syndrome (TG, HDL, resolution of MetS)(Baseline, 8 weeks, 12 weeks)
- Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)(Baseline, 8 weeks, 12 weeks)
- Body composition (weight, BMI, % body fat, % lean mass, waist-to-hip ratio, DEXA scanning)(Baseline, 8 weeks, 12 weeks)
- Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)(baseline, then every 2 weeks)