Clinical trial NCT01161706: Clinical Investigation on the Effects of a Vegetable Juice Treatment
Official title: The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vegetables
Cardiovascular Disease
Blood Pressure
Keywords: vegetable juice
cardiovascular
blood pressure
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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. 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.


Eligibility 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

Primary outcomes:
measure: Dietary Vegetable Intake
timeFrame: 6 and 12 weeks
measure: Dietary Nutrient Intake (vitamins & minerals)
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)
timeFrame: 0, 6 and 12 weeks
Other outcomes:
Locations:
city: Davis
country: United States
facility: Ragle Human Nutrition Research Center (1283 Academic Surge)
state: California
Study officials:
affiliation: Professor of Nutrition
name: Carl L Keen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.