Pre-hypertension Clinical Trial
Official title:
Association Between Consumption of Different Dosages of Bioactive Wheat Peptides and Blood Pressure (BP) Level and Other Biomarkers of Cardiovascular Disease Risk in Healthy Subjects With High-normal BP: a Double-blind, Cross-over, RCT
In this study we will assess the effects of bioactive peptide rich wheat products on blood
pressure and estimated cardiovascular disease risk. This will be a pilot, explorative,
cross-over, randomized double-blind 2 groups x 2-arms controlled, clinical trial. The
intervention will be based on commercially-packaged pasta, which will appear and taste the
same; (i) low dose bioactive peptides vs. (ii) high dose bioactive peptides. Inclusion
Criteria will be: Male and female non-diabetic adult volunteers at increased estimated CV
risk (ESC/EAS SCORE) with SBP 130-139 mmHg and/or DBP 85-90 mmHg); Age included between 40
and 70 years old; Primary prevention for CVD but otherwise in good general health and have
had no major illness in the previous 6-months; Volunteer providing their signed and dated
informed consent form. Exclusion Criteria will be: Severe medical illness/chronic
disease/gastrointestinal pathology (e.g. coeliac disease); Secondary prevention for CVD;
Treatment with drugs potentially affecting BP (including antihypertensive drugs) or other
related CV risk factors; Consumption of nutraceuticals, botanical extracts or other vitamin
supplements; Volunteer diagnosed as being hypertensive A total of 60 participants will be
recruited and following adherence to a standardized diet for a 4-week period, will be
randomly assigned to complete one of 2 treatment sequences by consuming a prescribed quantity
of pasta products for a 4-week period followed by a 4-week washout before random assignment
to the 2nd treatment.
The Primary Outcome will be the modification of office blood pressure (assessed by systolic
and diastolic BP, pulse and mean pressure (mean of 3 standing & sitting measures) and 24-hour
blood pressure.
Additional outcomes include: Anthropometric parameters (Weight, WC, HC, WC/HC, ICO, BMI),
Glucose and Lipid profile (TC, LDL-C, HDL-C, TG, non-HDL cholesterol, risk ratios), Estimated
CVD risk changes (EAS/ESC SCORE Charts), Measures of vascular health (FMD, PWA, PWV, Aix),
Liver and renal functionality biomarkers, 24-h urine collection at baseline of treatment
phase 1 and endpoint of the final phase will be analysed to account for potential confounding
of urinary sodium excretion (intake) As required by the GCPs and GLPs, all the SOPs have
already been established and all the personnel to be involved in the study is continuously
trained in trials with similar outcomes
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