- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132648
Curcumin and Exercise in Chronic Kidney Disease
Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Nicholas Kruse, Ph.D.
- Phone Number: 4199662797
- Email: nicholas-kruse-1@uiowa.edu
Study Contact Backup
- Name: Diana Jala, M.D.
- Phone Number: 7204254154
- Email: diana-jalal@uiowa.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)?
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Patients will receive placebo pill identical in appearance and taste to the supplement
|
Oral supplement one time at 2,000 mg
|
Experimental: Curcumin
Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials
|
Oral supplement one time at 2,000 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
%change forearm vascular condutance (FVC)
Time Frame: 2 hours
|
Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
forearm blood flow (FBF)
Time Frame: 2 hours
|
steady state FBF during forearm hand-grip exercise and CPT
|
2 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 201907819
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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