VegetablesPhase 1NCT01161706
Clinical Investigation on the Effects of a Vegetable Juice Treatment
A Phase 1 study testing Vegetable Juice in people with Vegetables and Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vegetables, Cardiovascular Disease, Blood Pressure
- What is being tested?
- Vegetable Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Research Center (1283 Academic Surge)
Davis, California, 95616
About this study
Official title: The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial
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.
- Conditions
- Vegetables, Cardiovascular Disease, Blood Pressure
- Being tested
- Vegetable Juice
- Keywords
- vegetable juice, cardiovascular, blood pressure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vegetable JuiceOther
Also called Commercial vegetable juice provided by Campbell Soup Company
Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet |
| 8 fluid ounces vegetable juice | Experimental | 8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet Receives: Other: Vegetable Juice |
| 16 fluid ounces vegetable juice | Experimental | 16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet Receives: Other: Vegetable Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Vegetable Intake
Measured: 6 and 12 weeks
Dietary Nutrient Intake (vitamins & minerals)
Measured: 6 and 12 weeks
Secondary outcomes (1)
Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)
Measured: 0, 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VegetablesStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Investigators
- Carl L Keen, PhD, Principal investigator, Professor of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161706
- Sponsor's protocol ID
- 200614971
- Status last verified
- Jul 2010
- First submitted
- 12 Jul 2010
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20849620
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01161706
- Acronym / sponsor ID
- 200614971
- Conditions
- Vegetables, Cardiovascular Disease, Blood Pressure
- Keywords
- vegetable juice, cardiovascular, blood pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet |
| 8 fluid ounces vegetable juice | Experimental | Other: Vegetable Juice8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet |
| 16 fluid ounces vegetable juice | Experimental | Other: Vegetable Juice16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- Physical signs of health impairment
- Uncontrolled diabetes or hypertension
- Pregnant or lactating
- Active tuberculosis or lung disease (i.e. COPD)
- Renal or Liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vegetable JuiceAlso: Commercial vegetable juice provided by Campbell Soup CompanyParticipants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces. | Other | 16 fluid ounces vegetable juice, 8 fluid ounces vegetable juice |
Primary outcome
Dietary Vegetable Intake
Time frame: 6 and 12 weeks
Dietary Nutrient Intake (vitamins & minerals)
Time frame: 6 and 12 weeks
1 secondary outcome
Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)
Time frame: 0, 6 and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
- Derived from this study: PubMed 20849620Shenoy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl L Keen, PhD principal investigator
Professor of Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vegetable Juice in people with Vegetables and Cardiovascular Disease, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Vegetable Intake (time frame: 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.