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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Blood Pressure Hyperemia Vasoconstriction||Drug: Curcumin Other: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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.|
|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|
Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials
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
Oral supplement one time at 2,000 mg
- %change forearm vascular condutance (FVC) [ Time Frame: 2 hours ]Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)
- forearm blood flow (FBF) [ Time Frame: 2 hours ]steady state FBF during forearm hand-grip exercise and CPT
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
|Contact: Nicholas Kruse, Ph.D.||email@example.com|
|Contact: Diana Jala, M.D.||firstname.lastname@example.org|