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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

July 12, 2010
July 12, 2010
July 2007
December 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Investigation on the Effects of a Vegetable Juice Treatment
The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Vegetables
  • Cardiovascular Disease
  • Blood Pressure
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
  • 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
    Intervention: Other: Vegetable Juice
  • Experimental: 16 fluid ounces vegetable juice
    16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
    Intervention: Other: Vegetable Juice
Shenoy SF, Kazaks AG, Holt RR, Chen HJ, Winters BL, Khoo CS, Poston WS, Haddock CK, Reeves RS, Foreyt JP, Gershwin ME, Keen CL. The use of a commercial vegetable juice as a practical means to increase vegetable intake: a randomized controlled trial. Nutr J. 2010 Sep 17;9:38.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
February 2009
December 2007   (final data collection date for primary outcome measure)

***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
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01161706
200614971
Yes
Sonia F. Shenoy, Postdoctoral Scholar, University of California, Davis
University of California, Davis
Not Provided
Principal Investigator: Carl L Keen, PhD Professor of Nutrition
University of California, Davis
July 2010

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