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History of Changes for Study: NCT02197910
Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
Latest version (submitted August 27, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 22, 2014 None (earliest Version on record)
2 August 27, 2015 Recruitment Status, Study Status and Contacts/Locations
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Study NCT02197910
Submitted Date:  July 22, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: BACCHUS_PASTATREND_2014
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2014
Overall Status: Not yet recruiting
Study Start: October 2014
Primary Completion: March 2015 [Anticipated]
Study Completion: May 2015 [Anticipated]
First Submitted: July 19, 2014
First Submitted that
Met QC Criteria:
July 22, 2014
First Posted: July 23, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 22, 2014
Last Update Posted: July 23, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Bologna
Responsible Party: Principal Investigator
Investigator: Claudio Borghi
Official Title: Prof.
Affiliation: University of Bologna
Collaborators: European Commission
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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

Detailed Description:
Open or close this module Conditions
Conditions: Pre-hypertension
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: High content of wheat bioactive peptides
100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)
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
Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Office blood pressure modification
[ Time Frame: 4 weeks ]

Systolic, diastolic, pulse, mean arterial pressure, pulse pressure index, mean of 3 consecutive measurement as for the European guidelines on blood pressure measurement suggestion
Secondary Outcome Measures:
1. 24-hour blood pressure modification (ABPM)
[ Time Frame: 4 weeks ]

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.
2. Cholesterolemia modification
[ Time Frame: 4 weeks ]

12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods
3. Flow-mediated vasodilation modification
[ Time Frame: 4 weeks ]

Evaluation of endothelial function by automatic measurement executed with the Vicorder Endopath instrument, already validated in previous publications
4. Fasting glucose modification
[ Time Frame: 4 weeks ]

12-hour fasting plasma glucose evaluated with standardized methods
5. Pulse Wave Velocity modification
[ Time Frame: 4 weeks ]

Evaluation of arterial stiffness measured as Pulse Wave Velocity and related parameters by the Vicorder instrument, already validated in previous publications
6. Triglyceridemia modification
[ Time Frame: 4 weeks ]

12-hour fasting triglyceridemia evaluated by standardized lab methos
Other Outcome Measures:
1. Anthropometric measurement changes
[ Time Frame: 4 weeks ]

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
2. Liver parameters modification
[ Time Frame: 4 weeks ]

12-hour liver transaminases, gamma-glutamyl-transferase, Lipid Accumulation Product, and Hepatic Steatosis Index evaluated with standardized methods
3. Renal function parameter modification
[ Time Frame: 4 weeks ]

12-hour fasting serum uric acid, creatinine, and estimated glomerular filtration rate (CKD-EPI formula) evaluated with standardized methods
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Claudio Borghi, MD
Email: claudio.borghi@unibo.it
Central Contact Backup: Arrigo FG Cicero, MD, PhD
Email: arrigo.cicero@unibo.it
Study Officials: Claudio Borghi, MD
Study Director
University of Bologna
Locations: Italy, BO
S. Orsola-Malpighi University Hospital
Bologna, BO, Italy, 40138
Contact:Contact: Arrigo FG Cicero, MD, PhD ++39516362224 arrigo.cicero@unibo.it
Contact:Sub-Investigator: Arrigo FG Cicero, MD, PhD
Contact:Principal Investigator: Claudio Borghi, MD, PhD
Contact:Sub-Investigator: Maddalena Veronesi, MD
Contact:Sub-Investigator: Sergio D'Addato, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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