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

NCT02197910 | Unknown

• 1 other identifier: BACCHUS_PASTATREND_2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pre-hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 24-hour blood pressure modification (ABPM)

  4 weeks

• Cholesterolemia modification

  4 weeks

• Flow-mediated vasodilation modification

  4 weeks

• Fasting glucose modification

  4 weeks

• Pulse Wave Velocity modification

  4 weeks

Other Outcomes (3)

• Anthropometric measurement changes

  4 weeks

• Liver parameters modification

  4 weeks

• Renal function parameter modification

  4 weeks

Study Arms (2)

High content of wheat bioactive peptides

ACTIVE COMPARATOR

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)

Low dose of wheat bioactive peptides

PLACEBO COMPARATOR

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)

Interventions

Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High) OTHER

Low dose of wheat bioactive peptides

Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low) OTHER

High content of wheat bioactive peptides

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead
• European Commission: collaborator

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Claudio Borghi, MD

  University of Bologna

  STUDY DIRECTOR

Central Study Contacts

Claudio Borghi, MD

CONTACT

claudio.borghi@unibo.it

Arrigo FG Cicero, MD, PhD

CONTACT

arrigo.cicero@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 19, 2014
• First Posted: July 23, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: August 28, 2015

Record last verified: 2015-08

Locations

IT (1)