HypertensionNCT00302809
Blood Pressure Lowering Effects of Grape Juice
A study testing Concord Grape Juice in people with Hypertension, run by Boston University at 1 site in United States.
Trial summary
Recent studies suggest that a diet rich in fruit and vegetables can lower blood pressure, and a number of lines of evidence suggest that grape products may have such an effect. The purpose of this study is to determine whether consuming grape juice lowers blood pressure in individuals with pre-hypertension or stage I… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Concord Grape Juice
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males and females
- Body Mass Index (BMI) of less than 35.0 kg/m2
- Systolic blood pressure (130-159 mmHg) and/or diastolic blood pressure (85-99 mm Hg) on two screening visits
- Subject must be judged to be in good health on the basis of medical history; 5. Subject must not be taking any antihypertensive medications for at least one month prior to the Screening Visit
Who cannot join
- History of clinically defined coronary artery disease, peripheral artery disease, stroke, active gastrointestinal ulcers, renal, or hepatic disease;
- History of bleeding disorders or malabsorption syndromes;
- Taking drugs for regulating hemostasis, including stable-dose aspirin;
- History of active cancer
- Females who are pregnant or planning to become pregnant
- Use of weight-loss drugs (including over-the-counter and dietary supplements)
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- Diagnosed diabetes mellitus
- Subjects who consume a vegetarian diet
- Recent history (within the past 6 months) of alcohol or substance abuse.
- Laboratory values outside the following ranges: serum potassium (3.5-5.1 mg/dl), creatinine (0.5-1.3 mg/dl), hematocrit (36-50%), white blood count (4.0-11.0 K/ul), platelet count (150-400 k/ul)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Concord Grape Juice on Blood Pressure and Vascular Function in Subjects With Pre-Hypertension and Stage 1 Hypertension
Recent studies suggest that a diet rich in fruit and vegetables can lower blood pressure, and a number of lines of evidence suggest that grape products may have such an effect. The purpose of this study is to determine whether consuming grape juice lowers blood pressure in individuals with pre-hypertension or stage I hypertension.
Read the detailed description
Elevated blood pressure (BP) is among the most common and important risk factors for atherosclerosis. A number of non-pharmacological therapies have successfully been applied to prevent the development of elevated BP or reduce elevated BP. For example the DASH Study showed that a diet rich in fruits, vegetables and low fat dairy products, and reduced in saturated fat, total fat and cholesterol, substantially lowered blood pressure in normotensive and hypertensive individuals.
Within the past three years a number of small clinical trials have suggested suggest that drinking purple grape juice for a period of 6-12 weeks may lower blood pressure individuals with elevated blood pressure. Other clinical trials have shown that Concord grape juice improves the function of the vascular endothelium, possibly providing an explanation for the beneficial effect. However, there is a need for a prospective, controlled study to determine whether grape juice has a beneficial effect on blood pressure.
The present study will compare the effect of drinking Concord purple grape juice (7 ml/kg or about 16 oz/day for a 70 kg person) and the effect of calorie-matched placebo on 24-hour ambulatory blood pressure, blood pressure reactivity, and vascular function in men and women in the category of "pre-hypertension" (defined as blood pressure greater than 120/80, but less than 149/89 mmHg and Stage 1 hypertension (defined as blood pressure greater than 140/90, but less than 160/100). This study will specifically recruit patients with systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg. The study will be double blind and have a crossover design with the order of treatment randomized (grape juice first or placebo first). A dietician will provide all subjects with formal instruction in a low salt diet, which is the current recommended initial therapy for patients with Stage 1 hypertension.
After a 1-week run-in period, subjects will consume each beverage for 8 weeks with a 4-week rest period between treatments. Blood pressure will be measured before and after each treatment period using a 24-hour ambulatory blood pressure recording. After each treatment period, we will measure changes in blood pressure induced by psychological challenge (mental arithmetic and computer tasks) and by the cold pressor test. In order to gain insight into the potential mechanisms of benefit, we will also examine the effects of beverage consumption on endothelial function, stiffness of the central aorta, fasting glucose and insulin, body weight, and markers of systemic inflammation, including CD40 ligand and C-reactive protein. Finally, we will store plasma samples for future investigation of other potential effects of grape juice on the cardiovascular system.
We hypothesize that Concord grape juice will have favorable effects on blood pressure compared to placebo.
- Conditions
- Hypertension
- Being tested
- Concord Grape Juice
- Keywords
- Flavonoids, Arterial stiffness, Blood pressure, Endothelium, Inflammation
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concord Grape JuiceDietary supplement
Approximately 16 oz of grape juice or placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measured by 24-hour recorder
Measured: 8 weeks
Secondary outcomes (3)
Pulse wave velocity
Measured: 8 weeks
Pulse amplitude tonometry
Measured: 8 weeks
Blood pressure during mental tasks
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 posted15 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMay 2009
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Welch's, Inc.
- Investigators
- Joseph A Vita, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302809
- Sponsor's protocol ID
- H-24568
- Status last verified
- Jun 2009
- First submitted
- 13 Mar 2006
- Last updated
- 18 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dohadwala MM, Hamburg NM, Holbrook M, Kim BH, Duess MA, Levit A, Titas M, Chung WB, Vincent FB, Caiano TL, Frame AA, Keaney JF Jr, Vita JA. Effects of Concord grape juice on ambulatory blood pressure in prehypertension and stage 1 hypertension. Am J Clin Nutr. 2010 Nov;92(5):1052-9. doi: 10.3945/ajcn.2010.29905. Epub 2010 Sep 15.
PubMed 20844075
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Concord Grape Juice on Blood Pressure and Vascular Function in Subjects With Pre-Hypertension and Stage 1 Hypertension
- ClinicalTrials.gov ID
- NCT00302809
- Acronym / sponsor ID
- H-24568
- Conditions
- Hypertension
- Keywords
- Flavonoids, Arterial stiffness, Blood pressure, Endothelium, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Welch's, Inc.
- Study start
- Mar 2006
- Study completion
- May 2009 (actual)
- First posted
- 15 Mar 2006 (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.
Recent studies suggest that a diet rich in fruit and vegetables can lower blood pressure, and a number of lines of evidence suggest that grape products may have such an effect. The purpose of this study is to determine whether consuming grape juice lowers blood pressure in individuals with pre-hypertension or stage I hypertension.
Detailed description
Elevated blood pressure (BP) is among the most common and important risk factors for atherosclerosis. A number of non-pharmacological therapies have successfully been applied to prevent the development of elevated BP or reduce elevated BP. For example the DASH Study showed that a diet rich in fruits, vegetables and low fat dairy products, and reduced in saturated fat, total fat and cholesterol, substantially lowered blood pressure in normotensive and hypertensive individuals.
Within the past three years a number of small clinical trials have suggested suggest that drinking purple grape juice for a period of 6-12 weeks may lower blood pressure individuals with elevated blood pressure. Other clinical trials have shown that Concord grape juice improves the function of the vascular endothelium, possibly providing an explanation for the beneficial effect. However, there is a need for a prospective, controlled study to determine whether grape juice has a beneficial effect on blood pressure.
The present study will compare the effect of drinking Concord purple grape juice (7 ml/kg or about 16 oz/day for a 70 kg person) and the effect of calorie-matched placebo on 24-hour ambulatory blood pressure, blood pressure reactivity, and vascular function in men and women in the category of "pre-hypertension" (defined as blood pressure greater than 120/80, but less than 149/89 mmHg and Stage 1 hypertension (defined as blood pressure greater than 140/90, but less than 160/100). This study will specifically recruit patients with systolic blood pressure of 130-159 mmHg or diastolic blood pressure of 85-99 mmHg. The study will be double blind and have a crossover design with the order of treatment randomized (grape juice first or placebo first). A dietician will provide all subjects with formal instruction in a low salt diet, which is the current recommended initial therapy for patients with Stage 1 hypertension.
After a 1-week run-in period, subjects will consume each beverage for 8 weeks with a 4-week rest period between treatments. Blood pressure will be measured before and after each treatment period using a 24-hour ambulatory blood pressure recording. After each treatment period, we will measure changes in blood pressure induced by psychological challenge (mental arithmetic and computer tasks) and by the cold pressor test. In order to gain insight into the potential mechanisms of benefit, we will also examine the effects of beverage consumption on endothelial function, stiffness of the central aorta, fasting glucose and insulin, body weight, and markers of systemic inflammation, including CD40 ligand and C-reactive protein. Finally, we will store plasma samples for future investigation of other potential effects of grape juice on the cardiovascular system.
We hypothesize that Concord grape juice will have favorable effects on blood pressure compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males and females
- Body Mass Index (BMI) of less than 35.0 kg/m2
- Systolic blood pressure (130-159 mmHg) and/or diastolic blood pressure (85-99 mm Hg) on two screening visits
- Subject must be judged to be in good health on the basis of medical history; 5. Subject must not be taking any antihypertensive medications for at least one month prior to the Screening Visit
Key exclusion criteria (10 listed)
- History of clinically defined coronary artery disease, peripheral artery disease, stroke, active gastrointestinal ulcers, renal, or hepatic disease;
- History of bleeding disorders or malabsorption syndromes;
- Taking drugs for regulating hemostasis, including stable-dose aspirin;
- History of active cancer
- Females who are pregnant or planning to become pregnant
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 |
|---|---|---|
| Concord Grape JuiceApproximately 16 oz of grape juice or placebo | Dietary supplement | – |
Primary outcome
Blood pressure measured by 24-hour recorder
Time frame: 8 weeks
3 secondary outcomes
Pulse wave velocity
Time frame: 8 weeks
Pulse amplitude tonometry
Time frame: 8 weeks
Blood pressure during mental tasks
Time frame: 8 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 18 Jun 2009.
- Derived from this study: PubMed 20844075Dohadwala MM, Hamburg NM, Holbrook M, Kim BH, Duess MA, Levit A, Titas M, Chung WB, Vincent FB, Caiano TL, Frame AA, Keaney JF Jr, Vita JA. Effects of Concord grape juice on ambulatory blood pressure in prehypertension and stage 1 hypertension. Am J Clin Nutr. 2010 Nov;92(5):1052-9. doi: 10.3945/ajcn.2010.29905. Epub 2010 Sep 15.
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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.
Joseph A Vita, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concord Grape Juice in people with Hypertension, run by Boston University at 1 site in United States.
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 10 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 18 Jun 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 United States. 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. 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?
Blood pressure measured by 24-hour recorder (time frame: 8 weeks). 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 NCT00302809, 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 18 Jun 2009.