Status:
COMPLETED
Clinical Investigation on the Effects of a Vegetable Juice Treatment
Lead Sponsor:
University of California, Davis
Conditions:
Vegetables
Cardiovascular Disease
Eligibility:
All Genders
40-65 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- \*\*\*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
Exclusion
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01161706
Start Date
July 1 2007
End Date
February 1 2009
Last Update
July 13 2010
Active Locations (1)
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1
Ragle Human Nutrition Research Center (1283 Academic Surge)
Davis, California, United States, 95616