Clinical Trials Directory

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

TypeNameDescription
OTHER2, 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

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.