Pre-hypertensionNCT02197910
Different Dosages of Bioactive Wheat Peptides and Blood Pressure Level and CVD Risk Biomarkers in Healthy Subjects
A study testing Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High) and Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low) in people with Pre-hypertension, run by University of Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension
- What is being tested?
- Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High) and Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Claudio Borghi, MD contact
Arrigo FG Cicero, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
S. Orsola-Malpighi University Hospital
Bologna, BO, 40138
Arrigo FG Cicero, MD, PhD, ++39516362224, arrigo.cicero@unibo.it
Arrigo FG Cicero, MD, PhD
About this study
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
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
- Being tested
- Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High), Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Other
| Study group | Role | What they receive |
|---|---|---|
| High content of wheat bioactive peptides | Active comparator | 100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides) Receives: 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 Receives: Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (6)
24-hour blood pressure modification (ABPM)
Twenty-four hour ambulatory blood pressure monitoring (ABPM) will be performed using a non-invasive automatic monitor (Space Labs, model 90207). For ABPM, patients will be instructed to act and work as normal between 6:00 AM and 10:00 PM and rest or sleep between 10:00 PM and 6:00 AM. Readings were obtained automatically at 15-min intervals throughout a 24-h study period. Separate averages will be obtained for the 24-h, daytime (6:00 AM-10:00 PM) and night-time (10:00 PM-6:00 AM) values. The accuracy of the automatic blood pressure readings will be checked against manual readings taken using a standard mercury sphygmomanometer, twice for each ABPM. Blood pressure were was measured with the patient sitting, before the beginning of the ABPM, and after a 5-min rest period. The accuracy test will be repeated after the end of each 24-h ABPM.
Measured: 4 weeks
Cholesterolemia modification
12-hour fasting Total, LDL, HDL and non HDL-Cholesterol, evaluated with standardized methods
Measured: 4 weeks
Flow-mediated vasodilation modification
Evaluation of endothelial function by automatic measurement executed with the Vicorder Endopath instrument, already validated in previous publications
Measured: 4 weeks
Fasting glucose modification
12-hour fasting plasma glucose evaluated with standardized methods
Measured: 4 weeks
Pulse Wave Velocity modification
Evaluation of arterial stiffness measured as Pulse Wave Velocity and related parameters by the Vicorder instrument, already validated in previous publications
Measured: 4 weeks
Triglyceridemia modification
12-hour fasting triglyceridemia evaluated by standardized lab methos
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Claudio Borghi, University of Bologna
- Investigators
- Claudio Borghi, MD, Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197910
- Sponsor's protocol ID
- BACCHUS_PASTATREND_2014
- Status last verified
- Aug 2015
- First submitted
- 19 Jul 2014
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02197910
- Acronym / sponsor ID
- BACCHUS_PASTATREND_2014
- Conditions
- Pre-hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High content of wheat bioactive peptides | Active comparator | Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)100 gr pasta/day, containing around 15 mg bioactive peptides (High content of wheat bioactive peptides) |
| Low dose of wheat bioactive peptides | Placebo comparator | Other: Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)100 gr pasta/day, containing around 3 mg bioactive peptides |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Office blood pressure modification
Time frame: 4 weeks
Systolic, diastolic, pulse, mean arterial pressure, pulse pressure index, mean of 3 consecutive measurement as for the European guidelines on blood pressure measurement suggestion
6 secondary outcomes
24-hour blood pressure modification (ABPM)
Time frame: 4 weeks
Cholesterolemia modification
Time frame: 4 weeks
Flow-mediated vasodilation modification
Time frame: 4 weeks
Fasting glucose modification
Time frame: 4 weeks
Pulse Wave Velocity modification
Time frame: 4 weeks
Triglyceridemia modification
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Borghi, MD contact
Arrigo FG Cicero, MD, PhD contact
Claudio Borghi, MD study director
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High) and Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low) in people with Pre-hypertension, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudio Borghi, MD (claudio.borghi@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office blood pressure modification (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2015.