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

NCT01454674 | Completed

• 1 other identifier: 07-0820-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.Implement a randomized vegetable feeding trial among overweight post- menopausal women
2. 2.Produce, in a controlled environmental setting, vegetable crops which provide a selected variety and quantity of carotenoid and nutrient exposure
3. 3.Assess changes and hopefully demonstrate a significant reduction in oxidant stress and inflammation in this population at risk for developing chronic disease

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (2)

• Serum high sensitivity c-reactive protein

  Change in serum high sensitivity c-reactive protein

  Change between baseline and 3 weeks

• Urine Isoprostanes 8-epi-PGF2alpha

  Change in Urine Isoprostanes 8-epi-PGF2alpha

  Change between baseline and 3 weeks

Secondary Outcomes (6)

• Plasma carotenoids

  Change between baseline and 3 weeks

• Physical activity - Arizona Activity Frequency Questionnaire

  Change between baseline and 21 weeks

• Body weight

  Change between baseline and 3 weeks

• Waist/hip circumference

  Change between baseline and 3 weeks

• Percent body fat

  Change between baseline and 3 weeks

Interventions

2, 5 & 10 Vegetable doses OTHER

2,5 \& 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers \& tomatoes consumed for 3 week intervals

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Arizona: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

U of AZ Nutritional Sciences Department

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia Thomson, PhD, RD

  U of AZ Nutritional Sciences Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: October 19, 2011
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

US (1)