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Curcumin and Exercise in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases, Blood Pressure, Hyperemia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Curcumin

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring CKD, Exercise, Vasoconstrictor Responsiveness

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)?

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin

Placebo

Arm Description

Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials

Patients will receive placebo pill identical in appearance and taste to the supplement

Outcomes

Primary Outcome Measures

%change forearm vascular condutance (FVC)

Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)

Secondary Outcome Measures

forearm blood flow (FBF)

steady state FBF during forearm hand-grip exercise and CPT

Full Information

NCT ID

NCT04132648

First Posted

October 17, 2019

Last Updated

February 16, 2023

Sponsor

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT04132648

Brief Title

Curcumin and Exercise in Chronic Kidney Disease

Official Title

Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Withdrawn

Why Stopped

PI left the Institution

Study Start Date

November 15, 2020 (Anticipated)

Primary Completion Date

November 1, 2021 (Anticipated)

Study Completion Date

November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Kidney Diseases, Blood Pressure, Hyperemia, Vasoconstriction

Keywords

CKD, Exercise, Vasoconstrictor Responsiveness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Patient, providers, and the investigative team will all be blinded to the randomization.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Curcumin

Arm Type

Experimental

Arm Description

Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients will receive placebo pill identical in appearance and taste to the supplement

Intervention Type

Drug

Intervention Name(s)

Curcumin

Other Intervention Name(s)

Longvida

Intervention Description

Oral supplement one time at 2,000 mg

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Oral supplement one time at 2,000 mg

Primary Outcome Measure Information:

Title

%change forearm vascular condutance (FVC)

Description

Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

forearm blood flow (FBF)

Description

steady state FBF during forearm hand-grip exercise and CPT

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)?

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Curcumin and Exercise in Chronic Kidney Disease

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