The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
Completed · Not applicable
Conditions studied: Chronic Disease
In brief
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
Key facts
- Study ID
- NCT01454674
- Run by
- University of Arizona
- People needed
- 75
- Starts
- 2007-10-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2011-10-19
Who can join
Age: 50 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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 ;
- 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 -
You may not qualify if…
- 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.
Where it is running
- U of AZ Nutritional Sciences Department — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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