Evidence map›Paper›PMID 32438639›Full record

Trial reportInternational journal of environmental research and public health2020

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.

Drew A Helmer, William W Van Doren, David R Litke, Chin-Lin Tseng, Lap Ho, Omowunmi Osinubi, Giulio Maria Pasinetti

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in International journal of environmental research and public health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02915237 (Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02915237 phase1 / phase2completednot on this map

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

TypeinterventionalSponsorIcahn School of Medicine at Mount SinaiRan2016 to 2019Enrolled36ConditionsGulf War IllnessArmsConcord grape juice, Placebo Beverage
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Drew A HelmerWar Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.
William W Van DorenWar Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.
David R LitkeWar Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.
Chin-Lin TsengWar Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.
Lap HoIcahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.
Omowunmi OsinubiWar Related Illness and Injury Study Center, Veterans Affairs New Jersey Healthcare System, 385 Tremont Avenue, East Orange, NJ 07018, USA.
Giulio Maria PasinettiIcahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Place, New York, NY 10029, USA.ORCID 0000-0002-1524-5196
VA New Jersey Health Care System · USIcahn School of Medicine at Mount Sinai · USMichael E. DeBakey VA Medical Center · USRutgers, The State University of New Jersey · USThe King's College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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,

Indexed as

Dietary SupplementsPersian Gulf SyndromeVeteransVitisCognition DisordersDouble-Blind MethodFatigueFemaleGulf WarHumansMaleMiddle Agedcognitive functioningconcord grape juicedietary polyphenolsfatigueGulf War illnessGulf War veteranssafetytolerabilityveteran

Identifiers

PMID32438639
PMCPMC7277758
OpenAlexW3027309952

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.