Blood Pressure Clinical Trial
Official title:
Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation
Verified date | February 2023 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility | 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)? |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | %change forearm vascular condutance (FVC) | Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT) | 2 hours | |
Secondary | forearm blood flow (FBF) | steady state FBF during forearm hand-grip exercise and CPT | 2 hours |
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