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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED)
Modified Mediterranean-style low-glycemic-load diet
Mark McIntosh MD
Jacksonville, Florida, United States
TG-to-HDL ratio
Time frame: Baseline, 8 weeks, 12 weeks
Components of metabolic syndrome (TG, HDL, resolution of MetS)
Time frame: Baseline, 8 weeks, 12 weeks
Glucose intolerance (fasting glucose/insulin, leptin, HbA1c, HOMA score)
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
Inflammatory cytokines (TNF-alpha, IL-6, sICAM, sVCAM, MCP1)
Time frame: 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
Subjective assessment (MOS-MCS/PCS questionnaires, VAS-satiety/craving questionnaires)
Time frame: baseline, then every 2 weeks
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