Trials / Completed
CompletedNCT01454674
The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- University of Arizona · Academic / Other
- Sex
- Female
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Accepted
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. Produce, in a controlled environmental setting, vegetable crops which provide a selected variety and quantity of carotenoid and nutrient exposure 3. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 2, 5 & 10 Vegetable doses | 2,5 \& 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers \& tomatoes consumed for 3 week intervals |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2010-06-01
- Completion
- 2011-08-01
- First posted
- 2011-10-19
- Last updated
- 2011-10-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01454674. Inclusion in this directory is not an endorsement.