Clinical Investigation on the Effects of a Vegetable Juice Treatment

University of California (UC) Davis

Status and phase

Completed

Phase 1

Conditions

Vegetables

Blood Pressure

Cardiovascular Disease

Treatments

Other: Vegetable Juice

Study type

Interventional

Funder types

Other

Identifiers

NCT01161706

200614971

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

All

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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