Status:
UNKNOWN
Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
Lead Sponsor:
University of Bologna
Collaborating Sponsors:
European Commission
Conditions:
Pre-hypertension
Eligibility:
All Genders
45-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02197910
Start Date
October 1 2014
End Date
March 1 2016
Last Update
August 28 2015
Active Locations (1)
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1
S. Orsola-Malpighi University Hospital
Bologna, BO, Italy, 40138