Elevated Blood PressureNCT00869193
Effect of Grape Seed Extract on Blood Pressure
A study testing Grape seed extract in people with Elevated Blood Pressure, run by Unilever R&D at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Elevated Blood Pressure
- What is being tested?
- Grape seed extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Jul 2009
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study
- BMI ≥ 18.5 and ≤ 30.0 kg/m2
- Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range
- Informed consent signed
- Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study
Who cannot join
- Mean of 6-hour ambulatory SBP < 120 mmHg, > 159 mmHg and/or DBP > 99 mmHg
- 10-year risk mortality risk on CVD > 10% according to NHG standard M84. For subjects > 65 years of age and SBP ≥ 140 mmHg the study physician will assess eligibility
- Irregular pulse or pulse < 50 or > 100 bpm
- Intense exercise >10 h/w
- Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination
- The habit of smoking during the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Grape Seed Extract High in Polyphenols on Blood Pressure in Subjects With Elevated Blood Pressure Levels
The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.
Read the detailed description
Background: High blood pressure is a major risk factor for morbidity and mortality from stroke, heart disease, and end-stage renal disease. Several studies have shown that dietary polyphenols derived from fruits and vegetables (including those from grape products) can lower blood pressure in both normotensive and hypertensive subjects.
Study objectives: Primary objective: To study, in subjects with elevated blood pressure levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic and diastolic blood pressure (SBP and DBP, respectively). Secondary objective: To explore mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood pressure lowering effect is shown.
Study population: Each treatment group will consist of 35 men and postmenopausal women (35-75 years of age) with daytime SBP between 120 and 159 mmHg. The total number of subjects will be 70.
Study design: This study will have a randomized, double-blind, placebo-controlled parallel design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. The 2 treatments will consist of placebo capsules and capsules with grape seed extract.
Study outcomes: Daytime ambulatory blood pressure (ABP) will be measured every 20 minutes for 2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. Furthermore, before and after the intervention period, 24-hour urine will be collected and 2 blood samples will be taken in order to investigate mechanistic pathways and platelet function.
- Conditions
- Elevated Blood Pressure
- Being tested
- Grape seed extract, Microcrystalline cellulose (placebo)
- Keywords
- Blood pressure, Grape seed
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape seed extractDietary supplement
Also called Polyphenol
Subjects will daily consume one capsule with grape seed extract for 8 weeks.
Microcrystalline cellulose (placebo)Dietary supplement
Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grape seed | Active comparator | Grape seed extract Receives: Dietary Supplement: Grape seed extract |
| Placebo | Placebo comparator | Microcrystalline cellulose Receives: Dietary Supplement: Microcrystalline cellulose (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure
Measured: 8 weeks of intervention
Secondary outcomes (1)
Difference between treatment and placebo in changes from baseline of mechanistic markers in plasma and/or urine (vasoactive factors and markers of polyphenol metabolism) and platelet function (only measured in case of a relevant BP-lowering effect)
Measured: 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Edinburgh
- Investigators
- Rouyanne T Ras, Msc, Principal investigator, Unilever R&D Vlaardingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869193
- Sponsor's protocol ID
- 08050V
- Status last verified
- Aug 2009
- First submitted
- 24 Mar 2009
- Last updated
- 28 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Grape Seed Extract High in Polyphenols on Blood Pressure in Subjects With Elevated Blood Pressure Levels
- ClinicalTrials.gov ID
- NCT00869193
- Acronym / sponsor ID
- 08050V
- Conditions
- Elevated Blood Pressure
- Keywords
- Blood pressure, Grape seed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University of Edinburgh
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Mar 2009 (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.
The purpose of this study is to determine whether an 8-week intervention with grape seed extract is effective in reducing daytime ambulatory blood pressure in male and postmenopausal female with elevated daytime blood pressure values.
Detailed description
Background: High blood pressure is a major risk factor for morbidity and mortality from stroke, heart disease, and end-stage renal disease. Several studies have shown that dietary polyphenols derived from fruits and vegetables (including those from grape products) can lower blood pressure in both normotensive and hypertensive subjects.
Study objectives: Primary objective: To study, in subjects with elevated blood pressure levels, the effects of grape seed extract high in polyphenols, on daytime ambulatory systolic and diastolic blood pressure (SBP and DBP, respectively). Secondary objective: To explore mechanistic pathways responsible for the blood pressure lowering efficacy in case a blood pressure lowering effect is shown.
Study population: Each treatment group will consist of 35 men and postmenopausal women (35-75 years of age) with daytime SBP between 120 and 159 mmHg. The total number of subjects will be 70.
Study design: This study will have a randomized, double-blind, placebo-controlled parallel design with 2 treatments, a 1-week run-in period, and an 8-week intervention period. The 2 treatments will consist of placebo capsules and capsules with grape seed extract.
Study outcomes: Daytime ambulatory blood pressure (ABP) will be measured every 20 minutes for 2 x 12 hours at baseline and 2 x 12 hours at the end of intervention. Furthermore, before and after the intervention period, 24-hour urine will be collected and 2 blood samples will be taken in order to investigate mechanistic pathways and platelet function.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grape seed | Active comparator | Dietary Supplement: Grape seed extractGrape seed extract |
| Placebo | Placebo comparator | Dietary Supplement: Microcrystalline cellulose (placebo)Microcrystalline cellulose |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and postmenopausal female subjects in the age ≥ 35 and ≤ 75 at start of the study
- BMI ≥ 18.5 and ≤ 30.0 kg/m2
- Apparently healthy: no reported diseases that may affect study results and pre-selected blood parameters within normal range
- Informed consent signed
- Willing to refrain from supplements, food products, diets and drugs that may interfere with the outcomes of the study
Key exclusion criteria (6 listed)
- Mean of 6-hour ambulatory SBP < 120 mmHg, > 159 mmHg and/or DBP > 99 mmHg
- 10-year risk mortality risk on CVD > 10% according to NHG standard M84. For subjects > 65 years of age and SBP ≥ 140 mmHg the study physician will assess eligibility
- Irregular pulse or pulse < 50 or > 100 bpm
- Intense exercise >10 h/w
- Reported weight loss/gain > 10% of body weight in the 6 month preceding pre-study examination
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 |
|---|---|---|
| Grape seed extractAlso: PolyphenolSubjects will daily consume one capsule with grape seed extract for 8 weeks. | Dietary supplement | Grape seed |
| Microcrystalline cellulose (placebo)Subjects will daily consume one capsule with microcrystalline cellulose for 8 weeks. | Dietary supplement | Placebo |
Primary outcome
Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure
Time frame: 8 weeks of intervention
1 secondary outcome
Difference between treatment and placebo in changes from baseline of mechanistic markers in plasma and/or urine (vasoactive factors and markers of polyphenol metabolism) and platelet function (only measured in case of a relevant BP-lowering effect)
Time frame: 8 weeks of intervention
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 28 Aug 2009.
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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.
Rouyanne T Ras, Msc principal investigator
Unilever R&D Vlaardingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape seed extract in people with Elevated Blood Pressure, run by Unilever R&D at 1 site in Netherlands.
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 6 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 28 Aug 2009. 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 Netherlands. 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?
Difference between treatment and placebo in changes from baseline of ambulatory systolic and diastolic blood pressure (time frame: 8 weeks of intervention). 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 2009.