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

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ClinicalTrials.gov Identifier: NCT02197910
Recruitment Status : Unknown
Verified August 2015 by Claudio Borghi, University of Bologna.
Recruitment status was:  Recruiting
First Posted : July 23, 2014
Last Update Posted : August 28, 2015
European Commission
Information provided by (Responsible Party):
Claudio Borghi, University of Bologna

Tracking Information
First Submitted Date  ICMJE July 19, 2014
First Posted Date  ICMJE July 23, 2014
Last Update Posted Date August 28, 2015
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2014)
  • 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.
  • Cholesterolemia modification [ Time Frame: 4 weeks ]
    12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods
  • 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
  • Fasting glucose modification [ Time Frame: 4 weeks ]
    12-hour fasting plasma glucose evaluated with standardized methods
  • 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
  • Triglyceridemia modification [ Time Frame: 4 weeks ]
    12-hour fasting triglyceridemia evaluated by standardized lab methos
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2014)
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pre-hypertension
Intervention  ICMJE
  • Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)
  • Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)
Study Arms  ICMJE
  • Active Comparator: High content of wheat bioactive peptides
    100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)
    Intervention: 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
    Intervention: Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 22, 2014)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02197910
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Claudio Borghi, University of Bologna
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Bologna
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE European Commission
Investigators  ICMJE
Study Director: Claudio Borghi, MD University of Bologna
PRS Account University of Bologna
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP