Ignite Creation Date:
2024-05-06 @ 3:04 AM
Last Modification Date:
2024-10-26 @ 11:28 AM
Study NCT ID:
NCT02197910
Status:
UNKNOWN
Last Update Posted:
2015-08-28
First Post:
2014-07-19
Brief Title:
Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
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
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ESCEAS SCORE with SBP 130-139 mmHg andor 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 illnesschronic diseasegastrointestinal pathology eg 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 WCHC ICO BMI Glucose and Lipid profile TC LDL-C HDL-C TG non-HDL cholesterol risk ratios Estimated CVD risk changes EASESC 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
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 WCHC ICO BMI Glucose and Lipid profile TC LDL-C HDL-C TG non-HDL cholesterol risk ratios Estimated CVD risk changes EASESC 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None