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

Primary Purpose

Chronic Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2, 5 & 10 Vegetable doses

About this trial

This is an interventional prevention trial for Chronic Disease

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

U of AZ Nutritional Sciences Department

Outcomes

Primary Outcome Measures

Serum high sensitivity c-reactive protein

Change in serum high sensitivity c-reactive protein

Urine Isoprostanes 8-epi-PGF2alpha

Change in Urine Isoprostanes 8-epi-PGF2alpha

Secondary Outcome Measures

Plasma carotenoids

Change in plasma carotenoids.

Physical activity - Arizona Activity Frequency Questionnaire

Change in physical activity.

Body weight

Change in body weight

Waist/hip circumference

Change in waist/hip circumference

Percent body fat

Change in % body fat

Blood pressure

Change in blood pressure

Full Information

NCT ID

NCT01454674

First Posted

August 11, 2011

Last Updated

October 18, 2011

Sponsor

University of Arizona

Collaborators

United States Department of Agriculture (USDA)

1. Study Identification

Unique Protocol Identification Number

NCT01454674

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

Collaborators

United States Department of Agriculture (USDA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

2, 5 & 10 Vegetable doses

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum high sensitivity c-reactive protein

Description

Change in serum high sensitivity c-reactive protein

Time Frame

Change between baseline and 3 weeks

Title

Urine Isoprostanes 8-epi-PGF2alpha

Description

Change in Urine Isoprostanes 8-epi-PGF2alpha

Time Frame

Change between baseline and 3 weeks

Secondary Outcome Measure Information:

Title

Plasma carotenoids

Description

Change in plasma carotenoids.

Time Frame

Change between baseline and 3 weeks

Title

Physical activity - Arizona Activity Frequency Questionnaire

Description

Change in physical activity.

Time Frame

Change between baseline and 21 weeks

Title

Body weight

Description

Change in body weight

Time Frame

Change between baseline and 3 weeks

Title

Waist/hip circumference

Description

Change in waist/hip circumference

Time Frame

Change between baseline and 3 weeks

Title

Percent body fat

Description

Change in % body fat

Time Frame

Change between baseline and 3 weeks

Title

Blood pressure

Description

Change in blood pressure

Time Frame

Change between baseline and 21 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cynthia Thomson, PhD, RD

Organizational Affiliation

U of AZ Nutritional Sciences Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

U of AZ Nutritional Sciences Department

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85721

Country

United States

12. IPD Sharing Statement

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

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