Chronic Kidney DiseasesPhase 2NCT04132648
Curcumin and Exercise in Chronic Kidney Disease
A Phase 2 study testing Curcumin in people with Chronic Kidney Diseases and Blood Pressure, run by University of Iowa.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Blood Pressure, Hyperemia
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2020to 1 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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?
Show all 47Show fewer
- 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)?
Who cannot join
None listed.
About this study
Official title: Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Blood Pressure, Hyperemia, Vasoconstriction
- Being tested
- Curcumin, Placebo
- Keywords
- CKD, Exercise, Vasoconstrictor Responsiveness
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called Longvida
Oral supplement one time at 2,000 mg
PlaceboOther
Oral supplement one time at 2,000 mg
| Study group | Role | What they receive |
|---|---|---|
| Curcumin | Experimental | Patients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials Receives: Drug: Curcumin |
| Placebo | Placebo comparator | Patients will receive placebo pill identical in appearance and taste to the supplement Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
%change forearm vascular condutance (FVC)
Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)
Measured: 2 hours
Secondary outcomes (1)
forearm blood flow (FBF)
steady state FBF during forearm hand-grip exercise and CPT
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start15 Nov 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Why it stopped: PI left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132648
- Sponsor's protocol ID
- 201907819
- Status last verified
- Feb 2023
- First submitted
- 17 Oct 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoconstrictor Responsiveness in Contracting Muscle of CKD: Influence of Acute Curcumin Supplementation
- ClinicalTrials.gov ID
- NCT04132648
- Acronym / sponsor ID
- 201907819
- Conditions
- Chronic Kidney Diseases, Blood Pressure, Hyperemia, Vasoconstriction
- Keywords
- CKD, Exercise, Vasoconstrictor Responsiveness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double-Blind Placebo-Controlled Crossover Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: CurcuminPatients will receive curcumin (Longvida) 2000 mg one time prior to exercise trials |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive placebo pill identical in appearance and taste to the supplement |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- 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?
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: LongvidaOral supplement one time at 2,000 mg | Drug | Curcumin |
| PlaceboOral supplement one time at 2,000 mg | Other | Placebo |
Primary outcome
%change forearm vascular condutance (FVC)
Time frame: 2 hours
Percentage reduction in FVC in response to acute sympathetic stimulus (cold pressor test; CPT)
1 secondary outcome
forearm blood flow (FBF)
Time frame: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Curcumin in people with Chronic Kidney Diseases and Blood Pressure, run by University of Iowa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%change forearm vascular condutance (FVC) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.