Clinical Investigation on the Effects of a Vegetable Juice Treatment
This study has been completed.
Sponsor:
University of California, Davis
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01161706
First received: July 12, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vegetables Cardiovascular Disease Blood Pressure |
Other: Vegetable Juice |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- Dietary Vegetable Intake [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
- Dietary Nutrient Intake (vitamins & minerals) [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress) [ Time Frame: 0, 6 and 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 90 |
| Study Start Date: | July 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
|
|
|
Experimental: 8 fluid ounces vegetable juice
8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
|
Other: Vegetable Juice
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
Other Name: Commercial vegetable juice provided by Campbell Soup Company
|
|
Experimental: 16 fluid ounces vegetable juice
16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet
|
Other: Vegetable Juice
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
Other Name: Commercial vegetable juice provided by Campbell Soup Company
|
Eligibility| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161706
Locations
| United States, California | |
| Ragle Human Nutrition Research Center (1283 Academic Surge) | |
| Davis, California, United States, 95616 | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | Carl L Keen, PhD | Professor of Nutrition |
More Information
No publications provided by University of California, Davis
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sonia F. Shenoy, Postdoctoral Scholar, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT01161706 History of Changes |
| Other Study ID Numbers: | 200614971 |
| Study First Received: | July 12, 2010 |
| Last Updated: | July 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
vegetable juice cardiovascular blood pressure |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013