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Trial record 100 of 531 for:    Taste Disorders

Nitrite-boosting Therapy for Improving Physiological Function in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03826147
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Seals, University of Colorado, Boulder

Brief Summary:
Nitric oxide (NO) is an essential molecule in the body that is decreased in patients with chronic kidney disease (CKD), leading to reductions in vascular, movement ("motor") and cognitive functions. This study will determine if daily oral supplementation (3 months) with a supplement that increases NO in the body, i.e., nitrate-rich beetroot juice, improves vascular, motor and cognitive function in patients with CKD; this study will also provide insight into the biological reasons (mechanisms) by which supplementation with nitrate-rich beetroot juice improves vascular function in these patients. Overall, this research will provide scientific evidence supporting the use of nitrate-rich beetroot juice for preserving physiological function and preventing co-morbid clinical conditions and disability in CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: Nitrate-rich beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Change in vascular endothelial function [ Time Frame: Baseline, 3 months ]
    as measured by brachial artery flow-mediated dilation

  2. Change in aortic stiffness [ Time Frame: Baseline, 3 months ]
    as measured by carotid-femoral pulse wave velocity


Secondary Outcome Measures :
  1. 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

  2. Change in endothelial cell markers of oxidative stress [ Time Frame: Baseline, 3 months ]
    Endothelial cell nitrotyrosine levels will be determined


Other Outcome Measures:
  1. 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)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CKD stage II-IV (eGFR using the Modification of Diet in Renal Disease (MDRD) prediction equation 20-90 mL/min/1.73m2; stable renal function in the past 3 months)
  • Ability to give informed consent
  • Albumin > 3.0 g/dL
  • Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 6 min, climb 10 stairs)
  • Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
  • Mini-mental state examination score >21 (rationale: to screen for subjects with major cognitive impairment)
  • Blood pressure (BP) >100/60 mmHg for past 3 months (rationale: blood pressure below 100/60 mmHg may elevate the normally small risk of hypotension with nitrate supplementation)
  • Not taking medications that will interfere with administered medications (e.g., sildenafil interacts with nitroglycerin)
  • Body mass index (BMI) <40 kg/m2 (vascular function measurements can be inaccurate in severely obese patients)

Exclusion Criteria:

  • Life expectancy <1 year
  • Uncontrolled hypertension, defined as blood pressure > 160/100 mmHg in the past 3 months
  • History of severe liver disease
  • History of severe congestive heart failure (i.e., ejection fraction < 35%)
  • History of hospitalizations within the last 3 months
  • Active infection or antibiotic therapy
  • Warfarin use
  • Vasculitis requiring immunosuppressive therapy within the last year
  • High dietary nitrate intake or current nitrate/nitrite supplementation; hypersensitivity to nitrates or nitrites
  • Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin >2%
  • Unwilling to abstain from use of mouthwash or other oral hygiene practices (e.g., tongue scraping) outside of teeth brushing that disrupt the oral microbiome and would interfere with nitrate conversion to nitrite
  • Blood donation within 8 weeks prior to enrolling in the study; unwilling to abstain from donating blood for 8 weeks after completing the study

Information from the National Library of Medicine

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


Contacts
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Contact: Morgan Berryman-Maciel 303-492-4568 beetrootstudy@colorado.edu

Locations
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United States, Colorado
Integrative Physiology of Aging Laboratory Recruiting
Boulder, Colorado, United States, 80309
Contact: Melanie R Zigler, M.S.    303-492-2485    melanie.connell@colorado.edu   
Sponsors and Collaborators
University of Colorado, Boulder

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Responsible Party: Douglas Seals, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT03826147     History of Changes
Other Study ID Numbers: 18-0364
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency