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

Table 4 Schedule of enrollment, interventions, and assessments

	Study period (weeks)
Visit #	Screening	1, 2	3, 4	4 week wash out	5, 6	7, 8
Study week	Screening	0	4 (+ 5 / -2 days)	4 week wash out	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						+

ISSN: 1745-6215