NCT00302809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

First QC Date

March 13, 2006

Last Update Submit

June 16, 2009

Conditions

Hypertension

Keywords

FlavonoidsArterial stiffnessBlood pressureEndotheliumInflammation

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measured by 24-hour recorder

    8 weeks

Secondary Outcomes (3)

  • Pulse wave velocity

    8 weeks

  • Pulse amplitude tonometry

    8 weeks

  • Blood pressure during mental tasks

    8 weeks

Interventions

Concord Grape JuiceDIETARY_SUPPLEMENT

Approximately 16 oz of grape juice or placebo

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 20844075DERIVED

MeSH Terms

Conditions

HypertensionInflammation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph A Vita, MD

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 15, 2006

Study Start

March 1, 2006

Study Completion

May 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

US(1)