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Resveratrol and Vascular Function in CKD

Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03597568
Enrollment
25
Registered
2018-07-24
Start date
2019-01-01
Completion date
2023-01-12
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Endothelial Dysfunction

Keywords

Resveratrol, Kidney Diseases, Renal Insufficiency, Diabetes, Oxidative stress, Endothelial dysfunction

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTResveratrol

Oral supplementation for 6 weeks

OTHERPlacebo

Oral supplementation for 6 weeks

Sponsors

Diana Jalal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
% Change of Brachial Artery Flow-mediated DilationFirst Baseline measurement to 6 weeks then Second baseline to 6 weeksBrachial 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

Secondary

MeasureTime frameDescription
Change in oxLDL6 weeksOxidized low density lipoprotein- (LDL) cholesterol Compare the 6 weeks change from baseline with resveratrol versus placebo

Countries

United States

Participant flow

Recruitment details

Consented 28 and randomized 25

Pre-assignment details

Randomized cross over design, each subject served as their own control. Randomized either to placebo first or resveratrol first. There was 2 week wash-out period.

Participants by arm

ArmCount
Resveratrol First
Randomized cross over design, subjects received either resveratrol or placebo first, 2 weeks washout separated the 2 treatments
13
Placebo First
Randomized cross over design, subjects received either resveratrol or placebo first, 2 weeks washout separated the 2 treatments
12
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyUnable to analyze vascular data11
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicResveratrol FirstPlacebo FirstTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants8 Participants19 Participants
Age, Categorical
Between 18 and 65 years
2 Participants2 Participants4 Participants
Age, Continuous68 years69 years68 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants10 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
13 Participants10 Participants23 Participants
Region of Enrollment
United States
13 participants10 participants23 participants
Sex: Female, Male
Female
2 Participants1 Participants3 Participants
Sex: Female, Male
Male
11 Participants9 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 25
other
Total, other adverse events
3 / 250 / 25
serious
Total, serious adverse events
1 / 250 / 25

Outcome results

Primary

% 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

Time frame: First Baseline measurement to 6 weeks then Second baseline to 6 weeks

Population: Randomized cross over design

ArmMeasureValue (MEAN)
Resveratrol% Change of Brachial Artery Flow-mediated Dilation1.3 %change
Placebo% Change of Brachial Artery Flow-mediated Dilation0.91 %change
Secondary

Change in oxLDL

Oxidized low density lipoprotein- (LDL) cholesterol Compare the 6 weeks change from baseline with resveratrol versus placebo

Time frame: 6 weeks

Population: oxLDL was measured and change from baseline was compared for both groups.

ArmMeasureValue (MEAN)
ResveratrolChange in oxLDL1.66 U/L
PlaceboChange in oxLDL1.38 U/L

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026