High-Normal Blood PressureCONDORNCT05167747
Food Supplementation With Diuripres for Blood Pressure Modulation in Subjects With High-Normal Blood Pressure
A study testing Dietary Supplement in people with High-Normal Blood Pressure, run by University of Bologna at 1 site in Italy.
Trial summary
Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, reaching the 31% of deaths in 2012. CVDs represent also the major cause of disability in developed countries and has been estimated that their growing burden could lead to a global increase in loss of disability-adjusted life years (DALY)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- High-Normal Blood Pressure
- What is being tested?
- Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 25 Mar 2022
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects agree to participate in the study and having dated and signed the informed consent form;
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- Subjects with high-normal blood pressure (SBP= 130-139 mmHg and/or DBP= 85-89 mmHg);
- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to 2018 ESC/ESH guidelines, the intervention strategy does not require a pharmacological intervention.
Who cannot join
- Subjects already affected by cardiovascular diseases (secondary prevention) or with an estimated 10 years cardiovascular disease risk> 5%;
- Obesity (Body mass index>30 kg/m2);
- Type 1 or type 2 diabetes;
- Assumption of anti-hypertensive drugs or food supplements, or drugs potentially affecting blood pressure;
- Lipid-lowering treatment not stabilized since at least 2 months;
- Anticoagulants therapy;
Show all 15Show fewer
- Known current thyroid, gastrointestinal or hepatobiliary diseases;
- Any medical or surgical condition that would limit the patient adhesion to the study protocol;
- Abuse of alcohol or drugs (current or previous);
- History of malignant neoplasia in the 5 years prior to enrolment in the study;
- History or clinical evidence of inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory diseases or current therapy with immunosuppressive agents or long-term glucocorticoids;
- History or clinical evidence of any significant concomitant disease that could compromise the safety of the subject or the possibility of completing the study;
- Known previous intolerance to one component of the tested nutraceuticals;
- Women in fertile age not using consolidated contraceptive methods;
- Pregnancy and Breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Effect of a Combined Nutraceutical and Placebo on Blood Pressure Level, Vascular Health, and Metabolic Parameters in Subjects Affected by Normal-High Blood Pressure
Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, reaching the 31% of deaths in 2012. CVDs represent also the major cause of disability in developed countries and has been estimated that their growing burden could lead to a global increase in loss of disability-adjusted life years (DALY), from a loss of 85 million DALYs of 1990 to a loss of ~ 150 million DALYs in 2020, becoming a major cause of no psychic responsible for lost productivity.
Several risk factors contribute to the aetiology and development of CVD. These factors have been traditionally stratified into modifiable risk factors through the lifestyle changes or by taking a pharmacologic treatment (e.g. hypertension, smoking, diabetes mellitus, hypercholesterolemia) and not modifiable risk factors (age, male sex and family history). Essential hypertension is the most common modifiable risk factor in the general population, with a prevalence in Western Countries -including Italy- ranging between about 25-45%.
Read more
Given the large prevalence of the disease of the general population, hypertension is responsible for the vast majority of CVD in individuals with different CV risk profiles, despite the availability of effective and well tolerated antihypertensive therapies. In this regard, several reports have shown that hypertensive patients often present additional CV and metabolic risk factors, mostly hypercholesterolemia, hypertriglyceridemia, metabolic syndrome and diabetes, which further contribute to increase the individual risk of developing hypertension-related complications, including stroke, end-stage renal disease, congestive heart failure, and CVD death. The concomitant presence of hypertension and dyslipidaemia is also responsible for the objective difficulty in achieving the recommended therapeutic targets for BP and cholesterol levels in a setting of clinical practice.
Several pharmacological and non-pharmacological interventions have been proposed for ameliorating the relatively low rates of control of hypertension. Among these, an extensive use of nutrients and food supplements has been shown to provide favourable effects in the management and control of high-normal blood pressure (BP) (or pre-hypertension), that increases the risk of developing hypertension, cardiovascular diseases, and renal failure.
Read the detailed description
Among food supplements largely used in this field, Orthosiphon stamineus Benth leaf extract has been recognized for its well-known diuretic properties; extract of hawthorn (Crataegus curvisepala Lind.) has been shown to exert a renal-protective effect in high salt-induced hypertension and extract of hibiscus (Hibiscus sabdariffa L.) is well known for its antihypertensive and vasodilator effect in human. Moreover, supplementation with magnesium has been recently found to play a critical role in BP regulation, through directly stimulating prostacyclin and nitric oxide formation, modulating endothelium-dependent and endothelium-independent vasodilation, reducing vascular tone and reactivity, and preventing vascular injury via its antioxidant and anti-inflammatory functions.
The objective of this study is to evaluate the effect of dietary supplementation of a combined food supplement (NUT) containing magnesium, standardized extract of orthosiphon (Orthosiphon stamineus Benth), standardized extract of hawthorn (Crataegus curvisepala Lind.) and standardized extract of hibiscus (Hibiscus sabdariffa L.) compared to placebo, on blood pressure and other markers of vascular aging in subjects with high-normal blood pressure.
- Conditions
- High-Normal Blood Pressure
- Being tested
- Dietary Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDietary supplement
Dietary supplement formulated with magnesium, standardized extract of orthosiphon, standardized extract of hawthorn and standardized extract of hibiscus. Each tablet contains: 0.1 g magnesium, 0.25 g standardized extract of orthosiphon (Orthosiphon stamineus Benth), 0.16 standardized extract of hawthorn (Crataegus curvisepala Lind.) and 0.08 g standardized extract of hibiscus (Hibiscus sabdariffa L.).
Oral administration: 2 tablets/day at evening meal
PlaceboOther
Oral administration: 2 tablets/day at evening meal
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Dietary supplement Receives: Dietary Supplement: Dietary Supplement |
| Placebo comparator | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure absolute reduction from baseline and between groups
Absolute reduction of systolic blood pressure after 8 weeks of treatment
Measured: 8 weeks
Diastolic blood pressure absolute reduction from baseline and between groups
Absolute reduction of diastolic blood pressure after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (46)
Systolic blood pressure absolute reduction from baseline and between groups
Absolute reduction of systolic blood pressure after 4 weeks of treatment
Measured: 4 weeks
Diastolic blood pressure absolute reduction from baseline and between groups
Absolute reduction of diastolic blood pressure after 4 weeks of treatment
Measured: 4 weeks
Percent reduction from baseline and between groups in vascular reactivity
Percent reduction of flow-mediated dilation (FMD) after 4 weeks of treatment
Measured: 4 weeks
Percent reduction from baseline and between groups in vascular reactivity
Percent reduction of flow-mediated dilation (FMD) after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in body weight
Absolute change of body weight after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in body weight
Absolute change of body weight after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in body mass index
Absolute change of body mass index after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in body mass index
Absolute change of body mass index after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in waist circumference
Absolute change of waist circumference after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in waist circumference
Absolute change of waist circumference after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in hip circumference
Absolute change of hip circumference after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in hip circumference
Absolute change of hip circumference after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in waist/hip circumference ratio
Absolute change waist/hip circumference ratio after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in waist/hip circumference ratio
Absolute change waist/hip circumference ratio after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in the index of central obesity
Absolute change of the index of central obesity after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in the index of central obesity
Absolute change of the index of central obesity after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in the visceral adiposity index
Absolute change of the visceral adiposity index after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in the visceral adiposity index
Absolute change of the visceral adiposity index after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in fat and lean mass
Absolute change of fat and lean mass after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in fat and lean mass
Absolute change of fat and lean mass after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in renal function
Absolute change of creatinine and the estimated glomerular filtration rate (eGFR) after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in renal function
Absolute change of creatinine and the estimated glomerular filtration rate (eGFR) after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in serum lipids
Absolute change of serum concentrations of total cholesterol, triglycerides - TG, high-density lipoprotein cholesterol - HDL-C, non-high-density lipoprotein cholesterol - non HDL-C, low-density lipoprotein cholesterol - LDL-C after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in lipids ratios
Absolute change of lipids ratios after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in serum lipids
Absolute change of serum concentrations of total cholesterol, triglycerides - TG, high-density lipoprotein cholesterol - HDL-C, non-high-density lipoprotein cholesterol - non HDL-C, low-density lipoprotein cholesterol - LDL-C after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in serum lipids ratios
Absolute change of lipids ratios after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in high sensitivity C reactive protein
Absolute change of high sensitivity C reactive protein (hsCRP) after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in high sensitivity C reactive protein
Absolute change of high sensitivity C reactive protein (hsCRP) after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in serum uric acid concentrations
Absolute change of serum uric acid after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in serum uric acid concentrations
Absolute change of serum uric acid after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in fasting plasma glucose concentrations
Absolute change of fasting plasma glucose after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in fasting plasma glucose concentrations
Absolute change of fasting plasma glucose after 8 weeks of treatment
Measured: 8 weeks
Treatment acceptability
Evaluation of patients' satisfaction assessed by a Visual Analogue Scale (VAS) scale (with two end points representing 0 -low acceptability- and 10 -high acceptability-) after 4 weeks of treatment
Measured: 4 weeks
Treatment acceptability
Evaluation of patients' satisfaction assessed by a Visual Analogue Scale (VAS) scale (with two end points representing 0 -low acceptability- and 10 -high acceptability-) after 8 weeks of treatment
Measured: 8 weeks
Treatment tolerability
Evaluation of treatment's tolerability assessed by patients with a Visual Analogue Scale (VAS) scale (with two end points representing 0 -no pain- and 10 -pain as bad as it could possibly be-) after 4 weeks of treatment
Measured: 4 weeks
Treatment tolerability
Evaluation of treatment's tolerability assessed by patients with a Visual Analogue Scale (VAS) scale (with two end points representing 0 -no pain- and 10 -pain as bad as it could possibly be-) after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in liver transaminases and gamma glutamil transferase
Absolute reduction of alanine aminotransferase, aspartate aminotransferase and gamma glutamil transferase after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in liver transaminases and gamma glutamil transferase
Absolute reduction of alanine aminotransferase, aspartate aminotransferase and gamma glutamil transferase after 8 weeks of treatment
Measured: 8 weeks
Absolute change from baseline and between groups in augumentation pressure
Absolute change of augumentation pressure after 4 weeks of treatment assessed by Vicorder software
Measured: 4 weeks
Absolute change from baseline and between groups in augumentation index
Absolute change of augumentation index after 4 weeks of treatment assessed by Vicorder software
Measured: 4 weeks
Absolute change from baseline and between groups in augumentation pressure
Absolute change of augumentation pressure after 8 weeks of treatment assessed by Vicorder software
Measured: 8 weeks
Absolute change from baseline and between groups in augumentation index
Absolute change of augumentation index after 8 weeks of treatment assessed by Vicorder software
Measured: 8 weeks
Percent change from baseline and between groups in the estimated body water content
Percent change of the body water content after 4 weeks of treatment, assessed by bioelectrical impedance analysis (BIA)
Measured: 4 weeks
Percent change from baseline and between groups in the estimated body water content
Percent change of the body water content after 8 weeks of treatment, assessed by bioelectrical impedance analysis (BIA)
Measured: 8 weeks
Absolute change from baseline and between groups in estimated risk of cardiovascular disease
Absolute change of the percent estimated risk of cardiovascular disease after 4 weeks of treatment
Measured: 4 weeks
Absolute change from baseline and between groups in estimated risk of cardiovascular disease
Absolute change of the percent estimated risk of cardiovascular disease after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Sep 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-Normal Blood PressureStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arrigo F.G. Cicero, University of Bologna
- Investigators
- Arrigo F. Cicero, MD, Principal investigator, S. Orsola-Malpighi University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167747
- Sponsor's protocol ID
- Pre-HPT_RCT_2021
- Acronym
- CONDOR
- Status last verified
- Jan 2024
- First submitted
- 28 May 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fogacci F, Degli Esposti D, Di Micoli A, Fiorini G, Veronesi M, Borghi C, Cicero AFG. Effect of dietary supplementation with Diuripres(R) on blood pressure, vascular health, and metabolic parameters in individuals with high-normal blood pressure or stage I hypertension: The CONDOR randomized clinical study. Phytother Res. 2023 Oct;37(10):4851-4861. doi: 10.1002/ptr.7951. Epub 2023 Jul 14.
PubMed 37448322
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Effect of a Combined Nutraceutical and Placebo on Blood Pressure Level, Vascular Health, and Metabolic Parameters in Subjects Affected by Normal-High Blood Pressure
- ClinicalTrials.gov ID
- NCT05167747
- Acronym / sponsor ID
- CONDOR / Pre-HPT_RCT_2021
- Conditions
- High-Normal Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 22 Dec 2021 (actual)
- 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.
Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, reaching the 31% of deaths in 2012. CVDs represent also the major cause of disability in developed countries and has been estimated that their growing burden could lead to a global increase in loss of disability-adjusted life years (DALY), from a loss of 85 million DALYs of 1990 to a loss of ~ 150 million DALYs in 2020, becoming a major cause of no psychic responsible for lost productivity.
Several risk factors contribute to the aetiology and development of CVD. These factors have been traditionally stratified into modifiable risk factors through the lifestyle changes or by taking a pharmacologic treatment (e.g. hypertension, smoking, diabetes mellitus, hypercholesterolemia) and not modifiable risk factors (age, male sex and family history). Essential hypertension is the most common modifiable risk factor in the general population, with a prevalence in Western Countries -including Italy- ranging between about 25-45%.
Given the large prevalence of the disease of the general population, hypertension is responsible for the vast majority of CVD in individuals with different CV risk profiles, despite the availability of effective and well tolerated antihypertensive therapies. In this regard, several reports have shown that hypertensive patients often present additional CV and metabolic risk factors, mostly hypercholesterolemia, hypertriglyceridemia, metabolic syndrome and diabetes, which further contribute to increase the individual risk of developing hypertension-related complications, including stroke, end-stage renal disease, congestive heart failure, and CVD death. The concomitant presence of hypertension and dyslipidaemia is also responsible for the objective difficulty in achieving the recommended therapeutic targets for BP and cholesterol levels in a setting of clinical practice.
Several pharmacological and non-pharmacological interventions have been proposed for ameliorating the relatively low rates of control of hypertension. Among these, an extensive use of nutrients and food supplements has been shown to provide favourable effects in the management and control of high-normal blood pressure (BP) (or pre-hypertension), that increases the risk of developing hypertension, cardiovascular diseases, and renal failure.
Detailed description
Among food supplements largely used in this field, Orthosiphon stamineus Benth leaf extract has been recognized for its well-known diuretic properties; extract of hawthorn (Crataegus curvisepala Lind.) has been shown to exert a renal-protective effect in high salt-induced hypertension and extract of hibiscus (Hibiscus sabdariffa L.) is well known for its antihypertensive and vasodilator effect in human. Moreover, supplementation with magnesium has been recently found to play a critical role in BP regulation, through directly stimulating prostacyclin and nitric oxide formation, modulating endothelium-dependent and endothelium-independent vasodilation, reducing vascular tone and reactivity, and preventing vascular injury via its antioxidant and anti-inflammatory functions.
The objective of this study is to evaluate the effect of dietary supplementation of a combined food supplement (NUT) containing magnesium, standardized extract of orthosiphon (Orthosiphon stamineus Benth), standardized extract of hawthorn (Crataegus curvisepala Lind.) and standardized extract of hibiscus (Hibiscus sabdariffa L.) compared to placebo, on blood pressure and other markers of vascular aging in subjects with high-normal blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Dietary Supplement: Dietary SupplementDietary supplement |
| Placebo comparator | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects agree to participate in the study and having dated and signed the informed consent form;
- Subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements;
- Subjects with high-normal blood pressure (SBP= 130-139 mmHg and/or DBP= 85-89 mmHg);
- Subjects who, according to the SCORE charts, have a low or moderate cardiovascular risk (defined as a total cardiovascular risk < 5%) and for whom, according to 2018 ESC/ESH guidelines, the intervention strategy does not require a pharmacological intervention.
Key exclusion criteria (15 listed)
- Subjects already affected by cardiovascular diseases (secondary prevention) or with an estimated 10 years cardiovascular disease risk> 5%;
- Obesity (Body mass index>30 kg/m2);
- Type 1 or type 2 diabetes;
- Assumption of anti-hypertensive drugs or food supplements, or drugs potentially affecting blood pressure;
- Lipid-lowering treatment not stabilized since at least 2 months;
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 |
|---|---|---|
| Dietary SupplementDietary supplement formulated with magnesium, standardized extract of orthosiphon, standardized extract of hawthorn and standardized extract of hibiscus. Each tablet contains: 0.1 g magnesium, 0.25 g standardized extract of orthosiphon (Orthosiphon stamineus Benth), 0.16 standardized extract of hawthorn (Crataegus curvisepala Lind.) and 0.08 g standardized extract of hibiscus (Hibiscus sabdariffa L.). Oral administration: 2 tablets/day at evening meal | Dietary supplement | Active Comparator |
| PlaceboOral administration: 2 tablets/day at evening meal | Other | Placebo comparator |
Primary outcome
Systolic blood pressure absolute reduction from baseline and between groups
Time frame: 8 weeks
Absolute reduction of systolic blood pressure after 8 weeks of treatment
Diastolic blood pressure absolute reduction from baseline and between groups
Time frame: 8 weeks
Absolute reduction of diastolic blood pressure after 8 weeks of treatment
46 secondary outcomes
Systolic blood pressure absolute reduction from baseline and between groups
Time frame: 4 weeks
Diastolic blood pressure absolute reduction from baseline and between groups
Time frame: 4 weeks
Percent reduction from baseline and between groups in vascular reactivity
Time frame: 4 weeks
Percent reduction from baseline and between groups in vascular reactivity
Time frame: 8 weeks
Absolute change from baseline and between groups in body weight
Time frame: 4 weeks
Absolute change from baseline and between groups in body weight
Time frame: 8 weeks
Absolute change from baseline and between groups in body mass index
Time frame: 4 weeks
Absolute change from baseline and between groups in body mass index
Time frame: 8 weeks
Absolute change from baseline and between groups in waist circumference
Time frame: 4 weeks
Absolute change from baseline and between groups in waist circumference
Time frame: 8 weeks
Absolute change from baseline and between groups in hip circumference
Time frame: 4 weeks
Absolute change from baseline and between groups in hip circumference
Time frame: 8 weeks
Absolute change from baseline and between groups in waist/hip circumference ratio
Time frame: 4 weeks
Absolute change from baseline and between groups in waist/hip circumference ratio
Time frame: 8 weeks
Absolute change from baseline and between groups in the index of central obesity
Time frame: 4 weeks
Absolute change from baseline and between groups in the index of central obesity
Time frame: 8 weeks
Absolute change from baseline and between groups in the visceral adiposity index
Time frame: 4 weeks
Absolute change from baseline and between groups in the visceral adiposity index
Time frame: 8 weeks
Absolute change from baseline and between groups in fat and lean mass
Time frame: 4 weeks
Absolute change from baseline and between groups in fat and lean mass
Time frame: 8 weeks
Absolute change from baseline and between groups in renal function
Time frame: 4 weeks
Absolute change from baseline and between groups in renal function
Time frame: 8 weeks
Absolute change from baseline and between groups in serum lipids
Time frame: 4 weeks
Absolute change from baseline and between groups in lipids ratios
Time frame: 4 weeks
Absolute change from baseline and between groups in serum lipids
Time frame: 8 weeks
Absolute change from baseline and between groups in serum lipids ratios
Time frame: 8 weeks
Absolute change from baseline and between groups in high sensitivity C reactive protein
Time frame: 4 weeks
Absolute change from baseline and between groups in high sensitivity C reactive protein
Time frame: 8 weeks
Absolute change from baseline and between groups in serum uric acid concentrations
Time frame: 4 weeks
Absolute change from baseline and between groups in serum uric acid concentrations
Time frame: 8 weeks
Absolute change from baseline and between groups in fasting plasma glucose concentrations
Time frame: 4 weeks
Absolute change from baseline and between groups in fasting plasma glucose concentrations
Time frame: 8 weeks
Treatment acceptability
Time frame: 4 weeks
Treatment acceptability
Time frame: 8 weeks
Treatment tolerability
Time frame: 4 weeks
Treatment tolerability
Time frame: 8 weeks
Absolute change from baseline and between groups in liver transaminases and gamma glutamil transferase
Time frame: 4 weeks
Absolute change from baseline and between groups in liver transaminases and gamma glutamil transferase
Time frame: 8 weeks
Absolute change from baseline and between groups in augumentation pressure
Time frame: 4 weeks
Absolute change from baseline and between groups in augumentation index
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Results publication: PubMed 37448322Fogacci F, Degli Esposti D, Di Micoli A, Fiorini G, Veronesi M, Borghi C, Cicero AFG. Effect of dietary supplementation with Diuripres(R) on blood pressure, vascular health, and metabolic parameters in individuals with high-normal blood pressure or stage I hypertension: The CONDOR randomized clinical study. Phytother Res. 2023 Oct;37(10):4851-4861. doi: 10.1002/ptr.7951. Epub 2023 Jul 14.
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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.
Arrigo F. Cicero, MD principal investigator
S. Orsola-Malpighi University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement in people with High-Normal Blood Pressure, 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 1 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure absolute reduction from baseline and between groups (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167747, which also lists 1 linked publication.
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 1 Feb 2024.