Chronic DiseaseNCT01454674
The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
A study testing 2, 5 & 10 Vegetable doses in people with Chronic Disease, run by University of Arizona at 1 site in United States.
Trial summary
The investigators have designed a three dose level, cross-over vegetable feeding study using expertise from nutritional sciences and plant sciences to: 1. Implement a randomized vegetable feeding trial among overweight post- menopausal women 2. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- 2, 5 & 10 Vegetable doses
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2011
- Phase
- Interventional
- 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 50 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female;
- Age 50 to 75 years of age;
- Target to include 20% minority subjects.
- Post-menopausal - defined as greater than 12 months without menses; or lab values indicative of post-menopausal status;
- Waist to hip ratio of > 0.85;
- Body mass index (BMI) between 25.0 and 45 kg/m2 ;
Show all 12Show fewer
- Non-smoker;
- Reported alcohol intake of < 2 servings daily;
- Reported stable body weight for previous 6 months;
- In general good health with no history of cancer (other than non- melanoma skin cancer), diabetes, liver or renal disease;
- No known allergies to or intolerances of leaf lettuce, tomato, carrots or peppers;
- Willing and able to successfully complete run-in activities -
Who cannot join
- Morbid obesity (BMI > 45 kg/m2);
- Medical diagnosis requiring a therapeutic diet (i.e, diabetes, hepatic disease, etc);
- Smoking history within previous 6 months;
- Consuming > 5 servings of fruits/vegetables daily prior to study enrollment;
- Regular use of anti-inflammatory medications;
- Unwilling to discontinue dietary supplements with the exception of study provided multivitamin and/or calcium supplement;
- Unwilling to adhere to study protocol including limiting fruit intake to 1 serving per day and excluding vegetable intake other than study provided and allowed vegetables.
- Participating in greater than 10 hours of regularly scheduled physical activity weekly or participating in vigorous physical activity on a regular basis (i.e. daily running, contact sports, etc) as assessed using a validated physical activity assessment questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
U of AZ Nutritional Sciences Department
Tucson, Arizona, 85721
About this study
The investigators have designed a three dose level, cross-over vegetable feeding study using expertise from nutritional sciences and plant sciences to:
- Implement a randomized vegetable feeding trial among overweight post- menopausal women
- Produce, in a controlled environmental setting, vegetable crops which provide a selected variety and quantity of carotenoid and nutrient exposure
- Assess changes and hopefully demonstrate a significant reduction in oxidant stress and inflammation in this population at risk for developing chronic disease
Read the detailed description
Women were randomly assigned a vegetable feeding dose order of consuming 2,5 \& 10 servings/day of vegetables for 3 week periods, with feeding periods separated by 4 week washout periods, during which time a limited number of low biological value fruits and vegetables were eaten.
This research will provide important and relevant information to fill several gaps in our current knowledge including a more thorough description of the oxidant stress and inflammatory status of overweight, postmenopausal women, assessment of the relevant daily "dose" of vegetables necessary to modulate biomarkers of oxidant stress and inflammation in overweight postmenopausal women and evaluation of the association between plasma nutrient and carotenoid levels in relation to changes in oxidant stress and inflammation in this population. Our long-term goal is to reduce chronic disease risk among "at-risk" post-menopausal females.
- Conditions
- Chronic Disease
- Being tested
- 2, 5 & 10 Vegetable doses
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2, 5 & 10 Vegetable dosesOther
2,5 \& 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers \& tomatoes consumed for 3 week intervals
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum high sensitivity c-reactive protein
Change in serum high sensitivity c-reactive protein
Measured: Change between baseline and 3 weeks
Urine Isoprostanes 8-epi-PGF2alpha
Change in Urine Isoprostanes 8-epi-PGF2alpha
Measured: Change between baseline and 3 weeks
Secondary outcomes (6)
Plasma carotenoids
Change in plasma carotenoids.
Measured: Change between baseline and 3 weeks
Physical activity - Arizona Activity Frequency Questionnaire
Change in physical activity.
Measured: Change between baseline and 21 weeks
Body weight
Change in body weight
Measured: Change between baseline and 3 weeks
Waist/hip circumference
Change in waist/hip circumference
Measured: Change between baseline and 3 weeks
Percent body fat
Change in % body fat
Measured: Change between baseline and 3 weeks
Blood pressure
Change in blood pressure
Measured: Change between baseline and 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2007
- Primary completionJun 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Julie West, University of Arizona
- Investigators
- Cynthia Thomson, PhD, RD, Principal investigator, U of AZ Nutritional Sciences Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454674
- Sponsor's protocol ID
- 07-0820-02
- Status last verified
- Oct 2011
- First submitted
- 11 Aug 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
- ClinicalTrials.gov ID
- NCT01454674
- Acronym / sponsor ID
- 07-0820-02
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Oct 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Oct 2011 (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 investigators have designed a three dose level, cross-over vegetable feeding study using expertise from nutritional sciences and plant sciences to:
- Implement a randomized vegetable feeding trial among overweight post- menopausal women
- Produce, in a controlled environmental setting, vegetable crops which provide a selected variety and quantity of carotenoid and nutrient exposure
- Assess changes and hopefully demonstrate a significant reduction in oxidant stress and inflammation in this population at risk for developing chronic disease
Detailed description
Women were randomly assigned a vegetable feeding dose order of consuming 2,5 \& 10 servings/day of vegetables for 3 week periods, with feeding periods separated by 4 week washout periods, during which time a limited number of low biological value fruits and vegetables were eaten.
This research will provide important and relevant information to fill several gaps in our current knowledge including a more thorough description of the oxidant stress and inflammatory status of overweight, postmenopausal women, assessment of the relevant daily "dose" of vegetables necessary to modulate biomarkers of oxidant stress and inflammation in overweight postmenopausal women and evaluation of the association between plasma nutrient and carotenoid levels in relation to changes in oxidant stress and inflammation in this population. Our long-term goal is to reduce chronic disease risk among "at-risk" post-menopausal females.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female;
- Age 50 to 75 years of age;
- Target to include 20% minority subjects.
- Post-menopausal - defined as greater than 12 months without menses; or lab values indicative of post-menopausal status;
- Waist to hip ratio of > 0.85;
Key exclusion criteria (8 listed)
- Morbid obesity (BMI > 45 kg/m2);
- Medical diagnosis requiring a therapeutic diet (i.e, diabetes, hepatic disease, etc);
- Smoking history within previous 6 months;
- Consuming > 5 servings of fruits/vegetables daily prior to study enrollment;
- Regular use of anti-inflammatory medications;
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 |
|---|---|---|
| 2, 5 & 10 Vegetable doses2,5 \& 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers \& tomatoes consumed for 3 week intervals | Other | – |
Primary outcome
Serum high sensitivity c-reactive protein
Time frame: Change between baseline and 3 weeks
Change in serum high sensitivity c-reactive protein
Urine Isoprostanes 8-epi-PGF2alpha
Time frame: Change between baseline and 3 weeks
Change in Urine Isoprostanes 8-epi-PGF2alpha
6 secondary outcomes
Plasma carotenoids
Time frame: Change between baseline and 3 weeks
Physical activity - Arizona Activity Frequency Questionnaire
Time frame: Change between baseline and 21 weeks
Body weight
Time frame: Change between baseline and 3 weeks
Waist/hip circumference
Time frame: Change between baseline and 3 weeks
Percent body fat
Time frame: Change between baseline and 3 weeks
Blood pressure
Time frame: Change between baseline and 21 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 19 Oct 2011.
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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.
Cynthia Thomson, PhD, RD principal investigator
U of AZ Nutritional Sciences Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2, 5 & 10 Vegetable doses in people with Chronic Disease, run by University of Arizona 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 12 inclusion and 8 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 19 Oct 2011. 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.
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?
Serum high sensitivity c-reactive protein (time frame: Change between baseline and 3 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?
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 19 Oct 2011.