Clinical Investigation on the Effects of a Vegetable Juice Treatment

Cardiovascular Disease Clinical Trial

Official title:

The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161706
• Other study ID #: 200614971
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2010
• Last updated: July 12, 2010
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

***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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Disease
• Cardiovascular Diseases
• Vegetables

Intervention

Other:
• Vegetable Juice
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.

Locations

Country	Name	City	State
United States	Ragle Human Nutrition Research Center (1283 Academic Surge)	Davis	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary Vegetable Intake		6 and 12 weeks	No
Primary	Dietary Nutrient Intake (vitamins & minerals)		6 and 12 weeks	No
Secondary	Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)		0, 6 and 12 weeks	No