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Clinical Investigation on the Effects of a Vegetable Juice Treatment

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01161706
First received: July 12, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

The purpose of the investigators study is to investigate the impact of a commercial vegetable juice on dietary vegetable intake and select cardiovascular risk factors in a generally healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the study.


Condition Intervention Phase
Vegetables
Cardiovascular Disease
Blood Pressure
Other: Vegetable Juice
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Dietary Vegetable Intake [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
  • Dietary Nutrient Intake (vitamins & minerals) [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
Experimental: 8 fluid ounces vegetable juice
8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
Other: Vegetable Juice
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
Other Name: Commercial vegetable juice provided by Campbell Soup Company
Experimental: 16 fluid ounces vegetable juice
16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
Other: Vegetable Juice
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
Other Name: Commercial vegetable juice provided by Campbell Soup Company

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

***Inclusion Criteria***

  • Age 40 to 65 yrs
  • Subject's body mass index is between 18.5 - 34.9 kg/m2
  • Subject is willing and able to comply with the study protocols
  • Subject is willing to consume a vegetable-based beverage daily for three months

***Exclusion Criteria***

  • Physical signs of health impairment
  • Uncontrolled diabetes or hypertension
  • Pregnant or lactating
  • Active tuberculosis or lung disease (i.e. COPD)
  • Renal or Liver disease
  • Heart Disease, which includes Cardiovascular events and Stroke
  • Cushing's syndrome
  • Exercise trained individuals
  • History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year
  • Anxiety medications
  • Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)
  • Quality of life score of 21 or above
  • Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs
  • Asthma (can be worsened by mild to moderate food allergies)
  • Indications of substance or alcohol abuse within the last 3 years
  • The volunteer is undergoing nicotine cessation therapy
  • Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin
  • Individuals with known salt-sensitive hypertension
  • History of stage 1 high blood pressure defined as systolic > 140 and diastolic > 90, with or without use of HTN medications
  • Multi-Vitamin use other than a One-A-Day essential
  • Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study
  • Allergies to vegetables
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161706

Locations
United States, California
Ragle Human Nutrition Research Center (1283 Academic Surge)
Davis, California, United States, 95616
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Carl L Keen, PhD Professor of Nutrition
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia F. Shenoy, Postdoctoral Scholar, University of California, Davis
ClinicalTrials.gov Identifier: NCT01161706     History of Changes
Other Study ID Numbers: 200614971
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
vegetable juice
cardiovascular
blood pressure

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014