Clinical Investigation on the Effects of a Vegetable Juice Treatment

Study Overview
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Brief Summary
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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.

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

Conditions
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Vegetables, Cardiovascular Disease, Blood Pressure

Intervention / Treatment
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* Other: Vegetable Juice


Participation Criteria
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Eligibility Criteria
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***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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet | |
| Experimental: 8 fluid ounces vegetable juice<br>8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet | Other: Vegetable Juice<br>* Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.<br>* Other names: Commercial vegetable juice provided by Campbell Soup Company;|
| Experimental: 16 fluid ounces vegetable juice<br>16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet | Other: Vegetable Juice<br>* Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.<br>* Other names: Commercial vegetable juice provided by Campbell Soup Company;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vegetable juice, cardiovascular, blood pressure