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

University of Bologna

Status: Unknown

Conditions: Pre-hypertension

Treatments: 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 type: Interventional

Funder types: Other

Identifiers

NCT02197910

BACCHUS_PASTATREND_2014

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

High content of wheat bioactive peptides

Active Comparator group

Description:

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

Treatment:

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 group

Description:

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

Treatment:

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