Cardiorenal Protective Diet (CPD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04117204|
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Cardiovascular Diseases Hypertension||Other: Fruits and Vegetables||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Identifying a Cardiorenal Protective Diet in a Lower-income African American Population With Chronic Kidney Disease at Risk for Cardiovascular Disease.|
|Actual Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Fruits and Vegetables
This group will receive a prescribed amount of free fruits and vegetables (F&V) for 6 weeks of pick-up at a farm stand or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F&V at farm stands for an additional 6 weeks with minimal contact.
Other: Fruits and Vegetables
Fruits and Vegetable delivery, once a week for 12 weeks.
No Intervention: Wait List Control
This group will not receive a prescribed amount of free fruits and vegetables (F&V) for 12 weeks. They will serve as the control group. After 12 weeks of control and data comparisons, they will be given 12 weeks of vouchers with minimal contact.
- Changes from baseline in fruit and vegetable intake at 6 weeks and 3 months. [ Time Frame: Baseline; 6 weeks and 3 months ]Track changes in fruit and vegetable intake via ASA24 dietary recall food diary.
- Changes from baseline in systolic and diastolic blood pressure at 6 weeks and 3 months. [ Time Frame: Baseline; 6 weeks and 3 months ]Measure changes in systolic/diastolic blood pressure (mmHg) to assess cardiovascular disease (CVD) risk.
- Change from baseline of urine albumin-to-creatinine ration (ACR) at 6 weeks and 3 months. [ Time Frame: Baseline; 6 weeks and 3 months ]Measure of renal damage.
- Metabolomics will be used to profile how changes in diet effects disease risk. [ Time Frame: Baseline and 6 Weeks ]Urine and plasma specimens will be collected for metabolomic analysis as novel biomarkers may appear in both sample types.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117204
|Contact: Heather Kitzman, PhD||214-865-3082||Heather.KitzmanCarmichael@BSWHealth.org|
|Contact: Brian Vilayvanh, BSN, RN||214-865-3071||Brian.Vilayvanh@BSWHealth.org|
|United States, Texas|
|Baylor Scott & White Health and Wellness Center||Recruiting|
|Dallas, Texas, United States, 75210|
|Contact: Brian Vilayvanh, BSN, RN 214-865-3071 Brian.Vilayvanh@BSWHealth.org|
|Contact: Patricia Allison, CHW 214-865-3053 Patricia.Allison@BSWHealth.org|
|Principal Investigator: Heather Kitzman, PhD|
|Sub-Investigator: Donald Wesson, MD, MBA|
|Principal Investigator:||Heather Kitzman, PhD||Baylor Scott & White Health and Wellness Center|