Status:
COMPLETED
The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Chronic Disease
Eligibility:
FEMALE
50-75 years
Phase:
NA
Brief 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 tri...
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...
Eligibility Criteria
Inclusion
- 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 -
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01454674
Start Date
October 1 2007
End Date
August 1 2011
Last Update
October 19 2011
Active Locations (1)
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1
U of AZ Nutritional Sciences Department
Tucson, Arizona, United States, 85721