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Blood Pressure Lowering Effects of Grape Juice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00302809
Recruitment Status : Completed
First Posted : March 15, 2006
Last Update Posted : June 18, 2009
Sponsor:
Collaborator:
Welch's, Inc.
Information provided by:
Boston University

Tracking Information
First Submitted Date  ICMJE March 13, 2006
First Posted Date  ICMJE March 15, 2006
Last Update Posted Date June 18, 2009
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
Blood pressure measured by 24-hour recorder [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2006)
Blood pressure measured by 24-hour recorder
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2007)
  • Pulse wave velocity [ Time Frame: 8 weeks ]
  • Pulse amplitude tonometry [ Time Frame: 8 weeks ]
  • Blood pressure during mental tasks [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2006)
  • Pulse wave velocity
  • Pulse amplitude tonometry
  • Blood pressure during mental tasks
  • Fasting glucose
  • Insulin
  • Body weight
  • CD40 ligand
  • C-reactive protein
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Pressure Lowering Effects of Grape Juice
Official Title  ICMJE Effect of Concord Grape Juice on Blood Pressure and Vascular Function in Subjects With Pre-Hypertension and Stage 1 Hypertension
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Dietary Supplement: Concord Grape Juice
Approximately 16 oz of grape juice or placebo
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 13, 2006)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00302809
Other Study ID Numbers  ICMJE H-24568
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joseph A. Vita, MD, Boston University
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE Welch's, Inc.
Investigators  ICMJE
Principal Investigator: Joseph A Vita, MD Boston University
PRS Account Boston University
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP