Resveratrol and Vascular Function in CKD

NCT03597568 | Completed Results DMC

• 1 other identifier: 201806073
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Endothelial Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• % 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

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

Secondary Outcomes (1)

• Change in oxLDL

  6 weeks

Study Arms (2)

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.

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.

Dietary Supplement: Resveratrol; Other: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Oral supplementation for 6 weeks

Placebo first, then resveratrol; Resveratrol first, then placebo

Placebo OTHER

Oral supplementation for 6 weeks

Placebo first, then resveratrol; Resveratrol first, then 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diana Jalal: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

Location

Related Publications (1)

• 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.

  PMID: 37843843 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Renal Insufficiency; Diabetes Mellitus

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Results Point of Contact

• Title: Dr. Diana Jalal
• Organization: University of I

diana-jalal@uiowa.edu

319-338-0581

Study Officials

• Diana Jalal

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2018
• First Posted: July 24, 2018
• Study Start: January 1, 2019
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)