Trial Outcomes & Findings for Resveratrol and Vascular Function in CKD (NCT NCT03597568)

Last Updated: 2024-11-01

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

First Baseline measurement to 6 weeks then Second baseline to 6 weeks

Results posted on

2024-11-01

Participant Flow

Consented 28 and randomized 25

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.

Participant milestones

Participant milestones
Measure	Resveratrol First Subjects received resveratrol 400 mg PO per day for 6 weeks then placebo after 2 week wash out period	Placebo First Subjects received placebo identical to the study drug for 6 weeks then resveratrol at 400 mg a day after a 2 week wash out
Overall Study STARTED	13	12
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Resveratrol First Subjects received resveratrol 400 mg PO per day for 6 weeks then placebo after 2 week wash out period	Placebo First Subjects received placebo identical to the study drug for 6 weeks then resveratrol at 400 mg a day after a 2 week wash out
Overall Study Withdrawal by Subject	1	1
Overall Study Unable to analyze vascular data	1	1

Baseline Characteristics

2 subjects in total in both arms did not have vascular images that could be analyzed.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: First Baseline measurement to 6 weeks then Second baseline to 6 weeks

Population: Randomized cross over design

Outcome measures

Outcome measures
Measure	Resveratrol n=21 Participants Resveratrol was compared to placebo in randomized cross over design	Placebo n=21 Participants Randomized cross over design
% Change of Brachial Artery Flow-mediated Dilation	1.3 %change Interval 1.06 to 1.61	0.91 %change Interval 0.74 to 1.12

SECONDARY outcome

Timeframe: 6 weeks

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

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

Outcome measures

Outcome measures
Measure	Resveratrol n=21 Participants Resveratrol was compared to placebo in randomized cross over design	Placebo n=21 Participants Randomized cross over design
Change in oxLDL	1.66 U/L Interval 1.15 to 2.32	1.38 U/L Interval 0.98 to 1.94

Adverse Events

Resveratrol

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Resveratrol n=25 participants at risk 6 weeks randomized cross over study, randomized to resveratrol first or placebo first, there was 2 week wash out period	Placebo n=25 participants at risk 6 weeks randomized cross over study, randomized to resveratrol first or placebo first, there was 2 week wash out period
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • Number of events 1 • 6 weeks of resveratrol supplementation	0.00% 0/25 • 6 weeks of resveratrol supplementation

Other adverse events

Other adverse events
Measure	Resveratrol n=25 participants at risk 6 weeks randomized cross over study, randomized to resveratrol first or placebo first, there was 2 week wash out period	Placebo n=25 participants at risk 6 weeks randomized cross over study, randomized to resveratrol first or placebo first, there was 2 week wash out period
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1 • 6 weeks of resveratrol supplementation	0.00% 0/25 • 6 weeks of resveratrol supplementation
General disorders Dizziness	8.0% 2/25 • Number of events 2 • 6 weeks of resveratrol supplementation	0.00% 0/25 • 6 weeks of resveratrol supplementation

Additional Information

Dr. Diana Jalal

University of I

Phone: 319-338-0581

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Resveratrol First n=13 Participants Randomized cross over design, subjects received either resveratrol or placebo first, 2 weeks washout separated the 2 treatments	Placebo First n=12 Participants Randomized cross over design, subjects received either resveratrol or placebo first, 2 weeks washout separated the 2 treatments	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=13 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	0 Participants n=10 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	0 Participants n=23 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.
Age, Categorical Between 18 and 65 years	2 Participants n=13 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	2 Participants n=10 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	4 Participants n=23 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.
Age, Categorical >=65 years	11 Participants n=13 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	8 Participants n=10 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.	19 Participants n=23 Participants • 2 subjects in total in both arms did not have vascular images that could be analyzed.
Age, Continuous	68 years n=13 Participants	69 years n=12 Participants	68 years n=25 Participants
Sex: Female, Male Female	2 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	1 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	3 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Sex: Female, Male Male	11 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	9 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	20 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	10 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	23 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) Asian	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) Black or African American	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) White	13 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	10 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	23 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) More than one race	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=13 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=10 Participants • 2 subjects did not have vascular images that could be analyzed	0 Participants n=23 Participants • 2 subjects did not have vascular images that could be analyzed
Region of Enrollment United States	13 participants n=13 Participants	10 participants n=12 Participants	23 participants n=25 Participants