Curcumin and Exercise in Chronic Kidney Disease

NCT04132648 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 201907819
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Diseases; Blood Pressure; Hyperemia; Vasoconstriction

Keywords

CKD; Exercise; Vasoconstrictor Responsiveness

Outcome Measures

Primary Outcomes (1)

• %change forearm vascular condutance (FVC)

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

  2 hours

Secondary Outcomes (1)

• forearm blood flow (FBF)

  2 hours

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Curcumin DRUG

Oral supplement one time at 2,000 mg

Also known as: Longvida

Curcumin

Placebo OTHER

Oral supplement one time at 2,000 mg

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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?

Sponsors & Collaborators

• University of Iowa: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperemia; Motor Activity

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patient, providers, and the investigative team will all be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: November 15, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 21, 2023

Record last verified: 2023-02