Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress

This study has been completed.
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Julie West, University of Arizona Identifier:
First received: August 11, 2011
Last updated: October 18, 2011
Last verified: October 2011

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

Condition Intervention
Chronic Disease
Other: 2, 5 & 10 Vegetable doses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Vegetable Dose Response Study: Effects of Consumption on Inflammation and Oxidative Stress

Resource links provided by NLM:

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Serum high sensitivity c-reactive protein [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in serum high sensitivity c-reactive protein

  • Urine Isoprostanes 8-epi-PGF2alpha [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in Urine Isoprostanes 8-epi-PGF2alpha

Secondary Outcome Measures:
  • Plasma carotenoids [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in plasma carotenoids.

  • Physical activity - Arizona Activity Frequency Questionnaire [ Time Frame: Change between baseline and 21 weeks ] [ Designated as safety issue: No ]
    Change in physical activity.

  • Body weight [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in body weight

  • Waist/hip circumference [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in waist/hip circumference

  • Percent body fat [ Time Frame: Change between baseline and 3 weeks ] [ Designated as safety issue: No ]
    Change in % body fat

  • Blood pressure [ Time Frame: Change between baseline and 21 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure

Enrollment: 75
Study Start Date: October 2007
Study Completion Date: August 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.


Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Female;
  2. Age 50 to 75 years of age;
  3. Target to include 20% minority subjects.
  4. Post-menopausal - defined as greater than 12 months without menses; or lab values indicative of post-menopausal status;
  5. Waist to hip ratio of > 0.85;
  6. Body mass index (BMI) between 25.0 and 45 kg/m2 ;
  7. Non-smoker;
  8. Reported alcohol intake of < 2 servings daily;
  9. Reported stable body weight for previous 6 months;
  10. In general good health with no history of cancer (other than non- melanoma skin cancer), diabetes, liver or renal disease;
  11. No known allergies to or intolerances of leaf lettuce, tomato, carrots or peppers;
  12. Willing and able to successfully complete run-in activities -

Exclusion Criteria:

  1. Morbid obesity (BMI > 45 kg/m2);
  2. Medical diagnosis requiring a therapeutic diet (i.e, diabetes, hepatic disease, etc);
  3. Smoking history within previous 6 months;
  4. Consuming > 5 servings of fruits/vegetables daily prior to study enrollment;
  5. Regular use of anti-inflammatory medications;
  6. Unwilling to discontinue dietary supplements with the exception of study provided multivitamin and/or calcium supplement;
  7. 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.
  8. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01454674

United States, Arizona
U of AZ Nutritional Sciences Department
Tucson, Arizona, United States, 85721
Sponsors and Collaborators
University of Arizona
USDA Beltsville Human Nutrition Research Center
Principal Investigator: Cynthia Thomson, PhD, RD U of AZ Nutritional Sciences Department
  More Information

No publications provided

Responsible Party: Julie West, Study coordinator, University of Arizona Identifier: NCT01454674     History of Changes
Other Study ID Numbers: 07-0820-02
Study First Received: August 11, 2011
Last Updated: October 18, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes processed this record on February 26, 2015