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Trial record 72 of 167 for:    curcumin

Curcumin and Exercise in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT04132648
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nicholas Kruse, University of Iowa

Brief Summary:
Chronic kidney disease (CKD) is associated with a pro-oxidative and pro-inflammatory state, and this is thought to contribute to a decrease in vascular function leading to greater cardiovascular disease (CVD) risk. Curcumin supplementation has been shown to reduce oxidative stress and improve endothelial function at rest in healthy older humans, although the magnitude of this effect remains unknown during exercise in CKD. The primary aim of this proposal is to determine whether exercising blood flow and vasoconstrictor responsiveness are improved as a result of acute oral supplementation with curcumin in patients with CKD. We hypothesize that: 1) acute curcumin supplementation will increase steady state exercise blood flow, and 2) reduce vasoconstriction induced by an acute sympathetic stimulus (cold pressor test) CKD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Blood Pressure Hyperemia Vasoconstriction Drug: Curcumin Other: Placebo Phase 2

Detailed Description:

Active muscles require an optimal amount of local blood flow to meet the functional and metabolic demand of the exercising muscle. It is well known that maximal aerobic work capacity and exercise tolerance are reduced in CKD, contributing to functional impairment and loss of independence. A multitude of factors may be responsible for this outcome including reduced blood flow to active muscle beds brought on by greater levels of oxidative stress in CKD. Aging and some individuals with disease (coronary artery disease, hypertension, diabetes) exhibit elevated resting sympathetic nerve activity (SNA), leading to greater vasoconstriction and pressor responses during exercise. However, the magnitude of this effect remains unknown in CKD. Importantly, there are a lack of interventions aimed at improving blood flow and reduce sympathetic mediated vasoconstriction in patients with CKD.

Recent evidence in aging humans suggest that curcumin supplementation improves vascular function by reducing oxidative stress. However, it remains unknown whether acute curcumin supplementation can be regarded as an effective therapeutic strategy aimed at modulating exercise vasodilation and sympathetic mediated vasoconstriction in CKD. Understanding the mechanisms that impair vascular function within exercising muscle is important when understanding implications for systemic blood pressure regulation, cardiovascular disease and functional work capacity in CKD. Therefore, identifying a low cost, non-pharmaceutical intervention and its potential impact on improving vascular function in CKD is a priority in preventative cardiovascular disease medicine.

The present proposal aims to examine the effect of sympathetic vasoconstriction on the differential changes in exercising blood flow in response to acute oral supplementation with curcumin in patients with CKD.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patient, providers, and the investigative team will all be blinded to the randomization.
Primary Purpose: Treatment
Official Title: Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials
Drug: Curcumin
Oral supplement one time at 2,000 mg
Other Name: Longvida

Placebo Comparator: Placebo
Patients will receive placebo pill identical in appearance and taste to the supplement
Other: Placebo
Oral supplement one time at 2,000 mg




Primary Outcome Measures :
  1. %change forearm vascular condutance (FVC) [ Time Frame: 2 hours ]
    Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)


Secondary Outcome Measures :
  1. forearm blood flow (FBF) [ Time Frame: 2 hours ]
    steady state FBF during forearm hand-grip exercise and CPT



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for CKD subjects:

Age 45-80 years old CKD stage III and IV (estimated glomerular filtration rate: 15-60 mL/min/1.73m2) BMI <40 kg/m2-1 Able to give informed consent

Exclusion Criteria for CKD subjects will include answering yes to the following questions:

  • Active participation in another study?
  • Dialysis?
  • End stage renal disease or kidney failure?
  • Kidney transplant?
  • Sever liver disease or transplant?
  • Diabetes?
  • Angina (i.e., chest discomfort/pain/pressure upon exertion)
  • Severe congestive heart failure?
  • Pacemaker/defibrillator?
  • Heart arrhythmia (i.e. Atrial fibrillation/flutter)?
  • Pregnant, breastfeeding, or unwilling to use adequate birth control?
  • Active infection or antibiotic therapy?
  • Immunosuppressive therapy within the last 3 months?
  • History of stroke?
  • Have you had a heart attack in the last 3 months?
  • Have you taken curcumin in last 3 months?
  • Current use of Hormone Replacement Therapy (if female)?
  • Current smoker?
  • Anemic (Hemoglobin count <9)?

Inclusion Criteria for healthy middle-age and older subjects:

Age 45-80 years old BMI <40 kg/m2 1 Able to give informed consent

Exclusion Criteria for health older subjects will include answering yes to the following questions:

  • Chronic kidney disease?
  • Hypertension?
  • Asthma?
  • Heart disease?
  • Clinical depression?
  • Autonomic disorders?
  • Sleep apnea?
  • Sever liver disease or transplant?
  • Diabetes?
  • Heart attack?
  • Angina (i.e., chest discomfort/pain/pressure upon exertion)
  • Severe systolic or congestive heart failure?
  • Heart angioplasty/stent or bypass surgery?
  • Heart valve surgery/replacement or valve disease?
  • Pacemaker/defibrillator?
  • Heart arrhythmia (i.e. Atrial fibrillation/flutter)?
  • Pregnant, breastfeeding, or unwilling to use adequate birth control?
  • Active infection or antibiotic therapy?
  • Immunosuppressive therapy within the last 3 months?
  • Have you taken curcumin in last 3 months?
  • Current use of Hormone Replacement Therapy (if female)?
  • Current smoker?
  • Anemic (Hemoglobin count <9)?

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): NCT04132648


Contacts
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Contact: Nicholas Kruse, Ph.D. 4199662797 nicholas-kruse-1@uiowa.edu
Contact: Diana Jala, M.D. 7204254154 diana-jalal@uiowa.edu

Sponsors and Collaborators
Nicholas Kruse

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Responsible Party: Nicholas Kruse, Postdoctoral Researcher, University of Iowa
ClinicalTrials.gov Identifier: NCT04132648     History of Changes
Other Study ID Numbers: 201907819
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nicholas Kruse, University of Iowa:
CKD
Exercise
Vasoconstrictor Responsiveness
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperemia
Urologic Diseases
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Curcumin
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action