NCT03665740

Multimodal Investigation of the Neuroprotective Effects of Resveratrol (MINER)

A Pilot RCT on the Effect of Resveratrol on Mood, Memory Deficits, Hippocampal Inflammation and Neurogenesis in Veterans With Gulf War Illness

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: VISN 17 Center of Excellence · Federal
• Sex: All
• Age: 44 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

Since their return from military service in the 1990-1991 Gulf War, many Veterans have been affected by debilitating symptoms that are not easily explained. A leading hypothesis states that the combination of exposure to toxic chemicals and environmental stressors are responsible for a cluster of debilitating symptoms known as Gulf War Illness (GWI). Research has found that over-the-counter antioxidant supplements such as resveratrol may reverse the damage that causes these debilitating symptoms. Resveratrol is a nutrient found abundantly in the skin of red grapes that is known to have robust antioxidant and anti-inflammatory properties. The investigators predict that resveratrol treatment will improve memory issues, difficulties with thinking and mood problems in Veterans with GWI and that resveratrol will do so with minimal risk.

Detailed description

A randomized controlled trial is proposed that will employ well-validated instruments and state-of-the-art techniques to assess improvements in cognitive functioning, functional status, mood, hippocampal neurogenesis and functional connectivity as well as anti-inflammatory and antioxidant effects of treatment with resveratrol. Design: The proposed study will be an intent-to-treat outpatient, randomized, double-blind, clinical trial of 93 Veterans who meet the Centers for Disease Control and Prevention and Kansas case definitions for GWI. The study involves a comparison of resveratrol at a dose of 2000 mg and placebo. All doses will be administered orally once or twice daily. Doses of resveratrol at 500 mg will begin with a dose titration period. In order to reach a maximum dose of 2000 mg for the resveratrol, titration will begin at 500 mg for 6 weeks, then increased to 1000 mg for 6 weeks and increased to 1500 mg for 6 weeks and increased to 2000 mg for the remaining 6 weeks on treatment. Morning dosing will be taken with or before breakfast. Evening dosing will be taken with or before dinner.

Conditions

• Gulf War Illness

Interventions

Type	Name	Description
DRUG	Resveratrol	resveratrol is an OTC supplement

Timeline

• Start date: 2018-08-01
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2018-09-11
• Last updated: 2018-09-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study