Chronic Kidney DiseasesNCT03597568
Resveratrol and Vascular Function in CKD
A study testing Resveratrol in people with Chronic Kidney Diseases and Endothelial Dysfunction, run by Diana Jalal at 1 site in United States.
Trial summary
The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Endothelial Dysfunction
- What is being tested?
- Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
- Able to give informed consent
- Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
- Type II diabetes mellitus
Who cannot join
- Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
- Life expectancy <1 year
- BMI >40 kg/m2 1
- Pregnant, breastfeeding, or unwilling to use adequate birth control
- Uncontrolled hypertension; blood pressure > 140/90
- Uncontrolled type II DM; AIC > 8.5
Show all 13Show fewer
- Currently taking anticoagulants including: coumadin, dalteparin, enoxaparin, haparin, and plavix.
- Severe liver disease
- Severe systolic heart failure
- Hospitalization within the last 3 months
- Active infection or antibiotic therapy
- Immunosuppressive therapy within the last year
- Currently partaking in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52245
About this study
Official title: Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.
Read the detailed description
Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction in CKD are a priority.
Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)
The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.
- Conditions
- Chronic Kidney Diseases, Endothelial Dysfunction
- Being tested
- Resveratrol, Placebo
- Keywords
- Resveratrol, Kidney Diseases, Renal Insufficiency, Diabetes, Oxidative stress, Endothelial dysfunction
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Renal Insufficiency, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDietary supplement
Oral supplementation for 6 weeks
PlaceboOther
Oral supplementation for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol first, then placebo | Experimental | Patients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening. After a minimum of 2 week washout period, subjects then took placebo for 6 weeks. Receives: Dietary Supplement: Resveratrol; Other: Placebo |
| Placebo first, then resveratrol | Placebo comparator | Patients will receive placebo pill identical in appearance and taste to the supplement. Subjects took this placebo twice daily, once in the morning and once in the evening. After a minimum of 2 week washout period, subjects then took resveratrol for 6 weeks. Receives: Dietary Supplement: Resveratrol; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change of Brachial Artery Flow-mediated Dilation
Brachial artery flow-mediated dilation, dilation of the brachial artery in response to shear stress.
Resveratrol first, then placebo:
Baseline to 6 weeks on Resveratrol Minimum 2 week washout Baseline to 6 week on placebo
Placebo first, then resveratrol:
Baseline to 6 weeks on placebo Minimum washout 2 weeks Baseline to 6 weeks on resveratrol
Measured: First Baseline measurement to 6 weeks then Second baseline to 6 weeks
Secondary outcomes (1)
Change in oxLDL
Oxidized low density lipoprotein- (LDL) cholesterol Compare the 6 weeks change from baseline with resveratrol versus placebo
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jan 2019
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized to either receive the following intervention: placebo or resveratrol for six weeks and then after a two week washout will be assigned the alternate study drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diana Jalal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diana Jalal, University of Iowa
- Investigators
- Diana Jalal, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597568
- Sponsor's protocol ID
- 201806073
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2018
- Last updated
- 1 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gimblet CJ, Kruse NT, Geasland K, Michelson J, Sun M, Mandukhail SR, Wendt LH, Eyck PT, Pierce GL, Jalal DI. Effect of Resveratrol on Endothelial Function in Patients with CKD and Diabetes: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):161-168. doi: 10.2215/CJN.0000000000000337. Epub 2023 Oct 16.
PubMed 37843843
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
- ClinicalTrials.gov ID
- NCT03597568
- Acronym / sponsor ID
- 201806073
- Conditions
- Chronic Kidney Diseases, Endothelial Dysfunction
- Keywords
- Resveratrol, Kidney Diseases, Renal Insufficiency, Diabetes, Oxidative stress, Endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Diana JalalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 1 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.
Detailed description
Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction in CKD are a priority.
Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)
The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.
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
- Subjects will be randomized to either receive the following intervention: placebo or resveratrol for six weeks and then after a two week washout will be assigned the alternate study drug.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol first, then placebo | Experimental | Dietary Supplement: Resveratrol, Other: PlaceboPatients will receive resveratrol 400 mg PO per day in divided doses of 200 mg in the morning and 200 mg in the evening. After a minimum of 2 week washout period, subjects then took placebo for 6 weeks. |
| Placebo first, then resveratrol | Placebo comparator | Dietary Supplement: Resveratrol, Other: PlaceboPatients will receive placebo pill identical in appearance and taste to the supplement. Subjects took this placebo twice daily, once in the morning and once in the evening. After a minimum of 2 week washout period, subjects then took resveratrol for 6 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
- Able to give informed consent
- Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
- Type II diabetes mellitus
Key exclusion criteria (13 listed)
- Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
- Life expectancy <1 year
- BMI >40 kg/m2 1
- Pregnant, breastfeeding, or unwilling to use adequate birth control
- Uncontrolled hypertension; blood pressure > 140/90
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 |
|---|---|---|
| ResveratrolOral supplementation for 6 weeks | Dietary supplement | Placebo first, then resveratrol, Resveratrol first, then placebo |
| PlaceboOral supplementation for 6 weeks | Other | Placebo first, then resveratrol, Resveratrol first, then placebo |
Primary outcome
% Change of Brachial Artery Flow-mediated Dilation
Time frame: First Baseline measurement to 6 weeks then Second baseline to 6 weeks
Brachial artery flow-mediated dilation, dilation of the brachial artery in response to shear stress. Resveratrol first, then placebo: Baseline to 6 weeks on Resveratrol Minimum 2 week washout Baseline to 6 week on placebo Placebo first, then resveratrol: Baseline to 6 weeks on placebo Minimum washout 2 weeks Baseline to 6 weeks on resveratrol
1 secondary outcome
Change in oxLDL
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37843843Gimblet CJ, Kruse NT, Geasland K, Michelson J, Sun M, Mandukhail SR, Wendt LH, Eyck PT, Pierce GL, Jalal DI. Effect of Resveratrol on Endothelial Function in Patients with CKD and Diabetes: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):161-168. doi: 10.2215/CJN.0000000000000337. Epub 2023 Oct 16.
- Individual participant dataSharing planned: No
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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.
Diana Jalal principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol in people with Chronic Kidney Diseases and Endothelial Dysfunction, run by Diana Jalal at 1 site in United States.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Brachial Artery Flow-mediated Dilation (time frame: First Baseline measurement to 6 weeks then Second baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597568, which also lists 1 linked publication.
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 1 Nov 2024.