The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
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
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress|
- 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
- Plasma carotenoids [ Time Frame: Change between baseline and 3 weeks ]Change in plasma carotenoids.
- Physical activity - Arizona Activity Frequency Questionnaire [ Time Frame: Change between baseline and 21 weeks ]Change in physical activity.
- Body weight [ Time Frame: Change between baseline and 3 weeks ]Change in body weight
- Waist/hip circumference [ Time Frame: Change between baseline and 3 weeks ]Change in waist/hip circumference
- Percent body fat [ Time Frame: Change between baseline and 3 weeks ]Change in % body fat
- Blood pressure [ Time Frame: Change between baseline and 21 weeks ]Change in blood pressure
|Study Start Date:||October 2007|
|Study Completion Date:||August 2011|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Other: 2, 5 & 10 Vegetable doses
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454674
|United States, Arizona|
|U of AZ Nutritional Sciences Department|
|Tucson, Arizona, United States, 85721|
|Principal Investigator:||Cynthia Thomson, PhD, RD||U of AZ Nutritional Sciences Department|