Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects

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

Study Overview

• Status: Unknown
• Conditions: Pre-hypertension
• Intervention / Treatment: Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low); Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • S. Orsola-Malpighi University Hospital
      • Contact: Arrigo FG Cicero, MD, PhD; Phone Number: ++39516362224; Email: arrigo.cicero@unibo.it
      • Sub-Investigator: Arrigo FG Cicero, MD, PhD
      • Principal Investigator: Claudio Borghi, MD, PhD
      • Sub-Investigator: Maddalena Veronesi, MD
      • Sub-Investigator: Sergio D'Addato, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High content of wheat bioactive peptides; 100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)	Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)
Placebo Comparator: Low dose of wheat bioactive peptides; 100 gr pasta/day, containing around 3 mg bioactive peptides	Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Office blood pressure modification	Systolic, diastolic, pulse, mean arterial pressure, pulse pressure index, mean of 3 consecutive measurement as for the European guidelines on blood pressure measurement suggestion	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour blood pressure modification (ABPM)	Twenty-four hour ambulatory blood pressure monitoring (ABPM) will be performed using a non-invasive automatic monitor (Space Labs, model 90207). For ABPM, patients will be instructed to act and work as normal between 6:00 AM and 10:00 PM and rest or sleep between 10:00 PM and 6:00 AM. Readings were obtained automatically at 15-min intervals throughout a 24-h study period. Separate averages will be obtained for the 24-h, daytime (6:00 AM-10:00 PM) and night-time (10:00 PM-6:00 AM) values. The accuracy of the automatic blood pressure readings will be checked against manual readings taken using a standard mercury sphygmomanometer, twice for each ABPM. Blood pressure were was measured with the patient sitting, before the beginning of the ABPM, and after a 5-min rest period. The accuracy test will be repeated after the end of each 24-h ABPM.	4 weeks
Cholesterolemia modification	12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods	4 weeks
Flow-mediated vasodilation modification	Evaluation of endothelial function by automatic measurement executed with the Vicorder Endopath instrument, already validated in previous publications	4 weeks
Fasting glucose modification	12-hour fasting plasma glucose evaluated with standardized methods	4 weeks
Pulse Wave Velocity modification	Evaluation of arterial stiffness measured as Pulse Wave Velocity and related parameters by the Vicorder instrument, already validated in previous publications	4 weeks
Triglyceridemia modification	12-hour fasting triglyceridemia evaluated by standardized lab methos	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric measurement changes	Height, weight, body mass index, waist circumference, hip circumference, waist/hip ratio, visceral adiposity index, index of central obesity measured from trained personnel following SOPs	4 weeks
Liver parameters modification	12-hour liver transaminases, gamma-glutamyl-transferase, Lipid Accumulation Product, and Hepatic Steatosis Index evaluated with standardized methods	4 weeks
Renal function parameter modification	12-hour fasting serum uric acid, creatinine, and estimated glomerular filtration rate (CKD-EPI formula) evaluated with standardized methods	4 weeks

Collaborators and Investigators

• Sponsor: University of Bologna
• Collaborators: European Commission
• Investigators: Study Director: Claudio Borghi, MD, University of Bologna

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: July 19, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): August 28, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: BACCHUS_PASTATREND_2014