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
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 April 22, 2014