Safety, Tolerability and Efficacy of Dietary Supplementation with Concord Grape Juice in Gulf War Veterans with Gulf War Illness: A Phase I/IIA, Randomized, Double-Blind, Placebo-Controlled Trial

Seguridad, tolerabilidad y eficacia de la suplementación dietética con jugo de uva Concord en veteranos de la Guerra del Golfo con la enfermedad de la Guerra del Golfo: un ensayo de fase I/IIA, aleatorizado, doble ciego y controlado con placebo

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ID: 114198
2020
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Abstract
Approximately 30 percent of U.S. veterans deployed during the Gulf War (1990–1991) have been diagnosed with Gulf War Illness (GWI), a chronic multi-symptom disorder without widely available specific treatments. We investigated whether the consumption of Concord grape juice (CGJ), rich in anti-inflammatory flavonoids, would be tolerated and safe in individuals with GWI and explored improvement in cognitive function and fatigue. Thirty-six veterans with GWI enrolled in a 24-week randomized, double-blind, Phase I/IIA clinical trial to explore safety, tolerability, and feasibility of 16 ounces daily of commercially available CGJ compared to placebo. Participants completed neurocognitive tests and self-reported surveys at baseline, 12 and 24 weeks. Thirty-one participants (86%) completed the study; no dropouts were related to side effects. Thirty participants (83%) documented ≥80% adherence. There were no statistically significant unadjusted differences between CGJ and placebo groups in change in efficacy measures from baseline to endpoint. We employed general linear regression models controlling for baseline differences between groups which indicated statistically significant improvement in the Halstead Category Test–Russell Revised Version (RCAT) at endpoint in the CGJ group compared to placebo (8.4 points, p = 0.04). Other measures of cognitive functioning did not indicate significant improvements in the adjusted analyses (p-values: 0.09–0.32), nor did the fatigue variable (p = 0.67). CGJ was safe and well-tolerated by veterans with GWI. Our data suggest high tolerability and potential benefit from CGJ in veterans with GWI and can be used to inform future studies of efficacy.
Aproximadamente el 30 por ciento de los veteranos de EE. UU. desplegados durante la Guerra del Golfo (1990–1991) han sido diagnosticados con la enfermedad de la Guerra del Golfo (GWI), un trastorno multisintomático crónico sin tratamientos específicos ampliamente disponibles. Investigamos si el consumo de jugo de uva Concord (CGJ), rico en flavonoides antiinflamatorios, sería tolerado y seguro en individuos con GWI, y exploramos la mejora en la función cognitiva y la fatiga. Treinta y seis veteranos con GWI se inscribieron en un ensayo clínico de fase I/IIA, aleatorizado, doble ciego y de 24 semanas para explorar la seguridad, tolerabilidad y viabilidad de 16 onzas diarias de CGJ disponible comercialmente en comparación con placebo. Los participantes completaron pruebas neurocognitivas y encuestas autoinformadas al inicio, a las 12 y a las 24 semanas. Treinta y un participantes (86%) completaron el estudio; ningún abandono estuvo relacionado con efectos secundarios. Treinta participantes (83%) documentaron una adherencia ≥80%. No hubo diferencias no ajustadas estadísticamente significativas entre los grupos de CGJ y placebo en el cambio de las medidas de eficacia desde el inicio hasta el criterio de valoración final. Empleamos modelos de regresión lineal general que controlaron las diferencias basales entre los grupos, los cuales indicaron una mejora estadísticamente significativa en la Prueba de Categorías de Halstead–Versión Revisada de Russell (RCAT) en el criterio de valoración final en el grupo de CGJ en comparación con el placebo (8,4 puntos, p = 0,04). Otras medidas del funcionamiento cognitivo no indicaron mejoras significativas en los análisis ajustados (valores de p: 0,09–0,32), así como tampoco la variable de fatiga (p = 0,67). El CGJ fue seguro y bien tolerado por los veteranos con GWI. Nuestros datos sugieren una alta tolerabilidad y un beneficio potencial del CGJ en veteranos con GWI, y pueden utilizarse para fundamentar futuros estudios de eficacia.
Reference Key
helmer2020internationalsafety, Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Drew A. Helmer;William W. Van Doren;David R. Litke;Chin-Lin Tseng;Lap Ho;Omowunmi Osinubi;Giulio Maria Pasinetti;Helmer, Drew A.;Van Doren, William W.;Litke, David R.;Tseng, Chin-Lin;Ho, Lap;Osinubi, Omowunmi;Pasinetti, Giulio Maria;
Journal International journal of environmental research and public health
Year 2020
DOI
10.3390/ijerph17103546
URL
https://www.mdpi.com/1660-4601/17/10/3546
Keywords
safety fatigue cognitive functioning veteran tolerability dietary polyphenols gulf war veterans gulf war illness concord grape juice

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