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Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness

NCT02915237 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-06-29

No results posted yet for this study

Summary

Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for GWI currently available, there is an urgent need to develop novel interventions to alleviate major GWI clinical complications. Recent evidence highlights the potential value of flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants and common dietary preparations, in helping relieve clinical complications in Veterans with GWI. The overall goal is to test whether daily consumption of commercially available Concord grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and chronic fatigue in Veterans with GWI.

Conditions

  • Gulf War Illness

Interventions

DIETARY_SUPPLEMENT

Concord grape juice

Daily dietary supplementation with a commercially available Concord grape juice.

DIETARY_SUPPLEMENT

Placebo Beverage

Daily dietary supplementation with a placebo beverage consisting of water, sugar, artificial flavoring and color that is formulated to look and taste like grape juice and have the same carbohydrate composition and energy load.

Sponsors & Collaborators

Principal Investigators

  • Giulio Maria Pasinetti, MD, PhD · Icahn School of Medicine at Mount Sinai

  • Brett Chaney, MD · United States Department of Defense

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-01-17
Completion
2019-01-17

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915237 on ClinicalTrials.gov