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Table 4 Schedule of enrollment, interventions, and assessments

From: Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study

 Study period (weeks)
Visit #Screening1, 23, 44 week wash out5, 67, 8
Study week04 (+  5 / -2 days)9 (+ 5 / -2 days)12 (+ 5 / -2 days)
Informed consent, demographic information, inclusion/exclusion criteria, and medical history+     
Vital signs and anthropometric measures (body weight, hip and waist circumference, BMI, blood pressure, arterial stiffness)+++ ++
Concomitant medications+++ ++
Genotyping of DNA samples+     
Blood lipid profile (TG, TC, LDL-C, HDL-C) and glucose+++ ++
Blood sterol and sterol precursor profile ++ ++
Gastrointestinal (GI) tolerability questionnaires ++ ++
Treatment Dispensation +  + 
Treatment Accountability
(Participant Consumption Checklist)
  +  +
treatment checklists  +  +
Adverse events  +  +
Study termination     +