Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease
|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: NCT03826147|
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Dietary Supplement: Nitrate-rich beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease|
|Actual Study Start Date :||May 18, 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||July 2023|
Active Comparator: Nitrate-rich beetroot juice
Daily dose of nitrate-rich beetroot juice (70 mL) for 3 months.
Dietary Supplement: Nitrate-rich beetroot juice
Daily supplementation with ~100 kcal of nitrate-rich beetroot juice containing 400 mg of dietary nitrate (James White Drinks, UK).
Placebo Comparator: Nitrate-depleted beetroot juice
Daily dose of nitrate-depleted beetroot juice (70 mL) for 3 months. The nitrate-depleted beetroot juice is identical in appearance, taste and caloric content to nitrate-rich beetroot juice, but with nitrate removed.
Dietary Supplement: Nitrate-depleted beetroot juice
Daily supplementation with ~100 kcal of nitrate-depleted beetroot juice (James White Drinks, UK).
- Change in vascular endothelial function [ Time Frame: Baseline, 3 months ]as measured by brachial artery flow-mediated dilation
- Change in aortic stiffness [ Time Frame: Baseline, 3 months ]as measured by carotid-femoral pulse wave velocity
- Change in oxidative stress-associated suppression of endothelial function assessed as the increase in brachial artery flow-mediated dilation following an ascorbic acid infusion [ Time Frame: Baseline, 3 months ]The influence of oxidative stress on brachial artery flow-mediated dilation will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline
- Change in endothelial cell markers of oxidative stress [ Time Frame: Baseline, 3 months ]Endothelial cell nitrotyrosine levels will be determined
- Motor function composite score [ Time Frame: Baseline, 3 months ]Multiple domains of motor function (including endurance, strength, dexterity) assessed using the NIH Toolbox Motor Battery (aggregated into one reported value)
- Fluid cognition composite score [ Time Frame: Baseline, 3 months ]Multiple domains of cognitive function (including executive function, memory, processing speed) assessed using the NIH Toolbox Cognitive Battery (aggregated into one reported value)
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): NCT03826147
|Contact: Morgan Berryman-Macielfirstname.lastname@example.org|
|United States, Colorado|
|Integrative Physiology of Aging Laboratory||Recruiting|
|Boulder, Colorado, United States, 80309|
|Contact: Melanie R Zigler, M.S. 303-492-2485 email@example.com|