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

NCT ID: NCT02197910

Last Updated: 2015-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High content of wheat bioactive peptides

100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Low dose of wheat bioactive peptides

100 gr pasta/day, containing around 3 mg bioactive peptides

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: OTHER

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Claudio Borghi

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Borghi, MD

Role: STUDY_DIRECTOR

University of Bologna

Locations

S. Orsola-Malpighi University Hospital

Bologna, BO, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Claudio Borghi, MD

Role: CONTACT

claudio.borghi@unibo.it

Arrigo FG Cicero, MD, PhD

Role: CONTACT

arrigo.cicero@unibo.it

Facility Contacts

Arrigo FG Cicero, MD, PhD

Role: primary

arrigo.cicero@unibo.it

++39516362224

Other Identifiers

BACCHUS_PASTATREND_2014

Identifier Type: -

Identifier Source: org_study_id