Clinical trial NCT02197910: Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-hypertension
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2014-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Primary prevention for cardiovascular diseases
* Systolic blood pressure 130-139 mmHg and/or Diastolic blood pressure 85-89 mmHg
* Estimated cardiovascular risk \>5% (Italian Heart Project cards)
* Ability of the volunteer to understand the study finalities and to adhere to the study protocol
* Signed informed consent

Exclusion Criteria:

* Secundary prevention for cardiovascular disease or high risk to develop cardiovascular disease
* Diabetes mellitus
* High level of a single cardiovascular disease risk factor (i.e.: severe hypertension/hypercholesterolemia)
* Chronic renal or liver failure
* Obesity (Body Mass Index\>30 kg/m2)
* Coeliac disease or gluten intolerance
* Assumption of antihypertensive drugs at antihypertensive dosage• Each medical or surgery condition potentially making difficult or inconstant the volunteer adhesion to the study protocol

Primary outcomes:
measure: Office blood pressure modification
timeFrame: 4 weeks
Secondary outcomes:
measure: 24-hour blood pressure modification (ABPM)
timeFrame: 4 weeks
measure: Cholesterolemia modification
timeFrame: 4 weeks
measure: Flow-mediated vasodilation modification
timeFrame: 4 weeks
measure: Fasting glucose modification
timeFrame: 4 weeks
measure: Pulse Wave Velocity modification
timeFrame: 4 weeks
measure: Triglyceridemia modification
timeFrame: 4 weeks
Other outcomes:
measure: Anthropometric measurement changes
timeFrame: 4 weeks
measure: Liver parameters modification
timeFrame: 4 weeks
measure: Renal function parameter modification
timeFrame: 4 weeks
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
state: BO
Study officials:
affiliation: University of Bologna
name: Claudio Borghi, MD
role: STUDY_DIRECTOR
References: