Blood Pressure Lowering Effects of Grape Juice

• ClinicalTrials.gov Identifier: NCT00302809
• Recruitment Status: Completed
• First Posted: March 15, 2006
• Last Update Posted: June 18, 2009
• Sponsor: Boston University
• Collaborator: Welch's, Inc.
• Information provided by: Boston University

Study Description

Brief 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 hypertension.

Condition or disease	Intervention/treatment	Phase
Hypertension	Dietary Supplement: Concord Grape Juice	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Concord Grape Juice on Blood Pressure and Vascular Function in Subjects With Pre-Hypertension and Stage 1 Hypertension
• Study Start Date: March 2006
• Actual Study Completion Date: May 2009

Arms and Interventions

Intervention Details:

• Dietary Supplement: Concord Grape Juice
  Approximately 16 oz of grape juice or placebo

Outcome Measures

Primary Outcome Measures :

1. Blood pressure measured by 24-hour recorder [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. Pulse wave velocity [ Time Frame: 8 weeks ]
2. Pulse amplitude tonometry [ Time Frame: 8 weeks ]
3. Blood pressure during mental tasks [ Time Frame: 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Adult males and females
2. Body Mass Index (BMI) of less than 35.0 kg/m2
3. Systolic blood pressure (130-159 mmHg) and/or diastolic blood pressure (85-99 mm Hg) on two screening visits
4. 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

Exclusion Criteria:

1. History of clinically defined coronary artery disease, peripheral artery disease, stroke, active gastrointestinal ulcers, renal, or hepatic disease;
2. History of bleeding disorders or malabsorption syndromes;
3. Taking drugs for regulating hemostasis, including stable-dose aspirin;
4. History of active cancer
5. Females who are pregnant or planning to become pregnant
6. Use of weight-loss drugs (including over-the-counter and dietary supplements)
7. Diagnosed diabetes mellitus
8. Subjects who consume a vegetarian diet
9. Recent history (within the past 6 months) of alcohol or substance abuse.
10. 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)

Contacts and Locations

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

Welch's, Inc.

Investigators

• Principal Investigator: Joseph A Vita, MD; Boston University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Joseph A. Vita, MD, Boston University
• ClinicalTrials.gov Identifier: NCT00302809
• Other Study ID Numbers: H-24568
• First Posted: March 15, 2006
• Last Update Posted: June 18, 2009
• Last Verified: June 2009

Keywords provided by Boston University:

Flavonoids; Arterial stiffness; Blood pressure; Endothelium; Inflammation

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases