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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Blood Pressure; Vegetables
• Intervention / Treatment: Other: Vegetable Juice

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • Ragle Human Nutrition Research Center (1283 Academic Surge)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

***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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Commercial vegetable juice provided by Campbell Soup Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dietary Vegetable Intake	6 and 12 weeks
Dietary Nutrient Intake (vitamins & minerals)	6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)	0, 6 and 12 weeks

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Carl L Keen, PhD, Professor of Nutrition

Publications and helpful links

General Publications

• 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. doi: 10.1186/1475-2891-9-38.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 13, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2010
• Last Update Submitted That Met QC Criteria: July 12, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: blood pressure; cardiovascular; vegetable juice
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 200614971