Study Design

• Double-blinded, placebo-controlled crossover design
• Experimental, randomized clinical trial
• 24 week study period divided into four phases of six weeks each:
• First Phase:
  6 week period during which all participants will eat a low fat, low cholesterol diet following the NCEP Step II recommendations
• Second Phase:
  6 week period which participants are randomly assigned either supplement or placebo therapy while continuing on NCEP Step II diet
• Third Phase:
  6 week washout period (participants do not have any supplements or placebos to take, but will continue on the NCEP Step II diet)
• Fourth Phase:
  6 week crossover period; participants will be crossed over to receive opposite therapy of supplements or placebo that they were on during the Second Phase

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Also available:
A view of the study design diagram (opens in new window).