scholarly journals A Low Glutamate Diet Improves Cognitive Functioning in Veterans with Gulf War Illness

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1217-1217
Author(s):  
Anna Kirkland ◽  
Elizabeth Brandley ◽  
Kathleen Holton
Keyword(s):  
Adult Adhd ◽  
Dietary Intervention ◽  
Gulf War ◽  
Self Report ◽  
Rank Test ◽  
Gulf War Illness ◽  
Double Blind ◽  
Cognitive Domains ◽  
Double Blind Placebo ◽  
The Us

Abstract Objectives The objective of this research was to investigate a novel low glutamate dietary intervention for Gulf War Illness (GWI), a chronic multi-symptom disorder that includes cognitive dysfunction. Methods Forty GW veterans with GWI were recruited from across the US. As part of a larger clinical trial, participants completed computerized cognitive testing and the Adult ADHD Self-Report Scale (ASRS) using CNS Vital Signs® (CNSVS) software. Before diet initiation, subjects received intensive dietary counseling. Post-diet assessments were completed after 1 month on the diet, and then participants were randomized to a 2-week double-blind placebo-controlled crossover challenge with glutamate (MSG)/placebo administered over 3 days of each week. The CNSVS battery was administered again on the 3rd day of each challenge week. The challenge data have not yet been un-blinded, and therefore will not be included in this abstract. Pre-post testing (t-test or Wilcoxon Signed Rank test) was conducted for each domain in the CNSVS battery, including an overall marker of neurocognitive function (NCI) and the ASRS. Results Several cognitive domains were significantly improved after 1-month on the low glutamate diet, including NCI (P < 0.01), executive functioning (P = 0.01), cognitive flexibility (P < 0.05), motor speed (P < 0.01), processing speed (P < 0.05), and psychomotor speed (P = 0.001). However, reaction time was slower at post-diet testing (P = 0.01). ADHD symptoms were also significantly improved at post-diet (P < 0.0001). Conclusions Veterans with GWI showed major improvements in cognitive function after 1-month on a low glutamate diet, including improvement in overall neurocognitive status. Upcoming analysis of the double-blind placebo-controlled crossover challenge data will provide additional information on which cognitive domains are directly affected by challenge with glutamate relative to placebo. Funding Sources The US Army Medical Research Acquisition Activity, 820 Chandler St, Fort Detrick MD 21,702–5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

scholarly journals The Effects of a Low Glutamate Dietary Intervention on Anxiety and PTSD in Veterans with Gulf War Illness (FS15-08-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Elizabeth Brandley ◽  
Anna Kirkland ◽  
Gabrielle Sarlo ◽  
John VanMeter ◽  
James Baraniuk ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Dietary Intervention ◽  
Monosodium Glutamate ◽  
Gulf War ◽  
Rank Test ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Gulf War Illness ◽  
Double Blind ◽  
Funding Sources

Abstract Objectives Glutamate is an amino acid and also serves as the most ubiquitous neurotransmitter in the human body. Previous work has shown that dysregulated glutamatergic neurotransmission is implicated in the etiology of anxiety disorders. Objective: To examine the effect of a low glutamate dietary intervention on anxiety and Posttraumatic Stress Disorder (PTSD) in veterans with Gulf War Illness (GWI). Methods Forty veterans with GWI are being recruited for a randomized-controlled clinical trial testing the effects of a low glutamate diet on neurological symptoms. After consent, subjects complete baseline measures, then subjects are randomized to the low-glutamate diet or a wait-listed control group. For the active intervention phase, they follow a 1-month low glutamate diet and then are re-tested prior to entering a double-blind, placebo-controlled crossover challenge with monosodium glutamate (MSG) or placebo, to test for return of symptoms. Preliminary data are presented here for changes observed on the Generalized Anxiety Disorder 7-item (GAD-7) scale and the PTSD Checklist (PCL-C) after one month on the diet in subjects recruited to date. Pre-post diet scores were compared for anxiety and PTSD using a Wilcoxon Signed Rank test in SAS. Results Seventeen veterans (M = 15; F = 2) with GWI have been recruited to date (mean age = 50 ± 4 yrs). Preliminary analyses demonstrate that after one month on the diet, significant improvements were noted for anxiety (score reduced from a median (IQ range) of 9 (13) to 5 (10), p = 0.01) and for PTSD (median (IQ) score reduced from 58 (33) to 43 (28), p = 0.04). Conclusions This study suggests that consuming a low glutamate diet may improve anxiety and PTSD in veterans suffering from Gulf War Illness. More research is needed to further explore the role of dietary glutamate in anxiety disorders. Funding Sources U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Gulf War Illness Research Program under Award No. W81XWH-17-1-0457. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

scholarly journals Gulf War Veterans with Psychiatric Symptoms (Anxiety, Depression, and PTSD) Significantly Improve on a Low Glutamate Diet

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1192-1192
Author(s):  
Elizabeth Brandley ◽  
Anna Kirkland ◽  
Kathleen Holton
Keyword(s):  
Dietary Intervention ◽  
Psychiatric Symptoms ◽  
Gulf War ◽  
Control Group ◽  
Gulf War Illness ◽  
War Veterans ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Gulf War Veterans ◽  
Anxiety Depression

Abstract Objectives The objective of this study was to assess the effects of a low glutamate dietary intervention on measures of anxiety, depression, and PTSD in veterans with Gulf War Illness (GWI). Methods Forty Gulf War veterans were recruited from across the U.S. for a clinical trial examining the effects of a low glutamate diet on symptoms of GWI. During baseline testing, subjects completed the GAD-7 anxiety measure, the PCL-C PTSD scale, and the Center for Epidemiologic Studies Depression Scale (CES-D), and then were randomized to immediate dietary intervention or a wait-listed control group. All participants received intensive dietary training before starting the diet. After one month on the diet, post-diet testing was completed, then subjects were randomized into a double-blind, placebo-controlled crossover challenge with MSG/placebo to test for a return of symptoms. The challenge data has not yet been un-blinded; therefore, it will not be discussed in this abstract. Pre-post diet change scores were analyzed using the Wilcoxon Signed Rank tests via SPSS®v26. Results Results demonstrate highly significant improvements in psychiatric symptoms associated with GWI after one-month on a low glutamate diet. Scores were reduced from a median (IQ range) of 9(13) to 4(8), P = 0.001 for anxiety; from 27(15) to 19(10), P < 0.001 for depression; and from 57(32) to 39(32), P < 0.001 for PTSD. Conclusions These results suggest that a low glutamate diet may improve depression, anxiety, and PTSD in veterans with GWI. Future analysis of the double-blind, placebo-controlled crossover challenge data will provide a better understanding of whether challenge with glutamate can significantly increase anxiety, depression and PTSD relative to placebo. Funding Sources The US Army Medical Research Acquisition Activity, 820 Chandler St, Fort Detrick MD 21,702–5014 is the awarding and administering acquisition office. This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Gulf War Illness Research Program. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

scholarly journals The Low Glutamate Diet Significantly Improves Pain and Other Symptoms in Veterans with Gulf War Illness

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 1211-1211
Author(s):  
Kathleen Holton ◽  
Anna Kirkland ◽  
Elizabeth Brandley ◽  
John VanMeter ◽  
James Baraniuk
Keyword(s):  
Chronic Pain ◽  
Effect Size ◽  
Dietary Intervention ◽  
Monosodium Glutamate ◽  
Gulf War ◽  
Diet Group ◽  
Control Group ◽  
Diet Change ◽  
Gulf War Illness ◽  
Double Blind

Abstract Objectives The objective was to examine if a low glutamate diet can reduce symptoms in Gulf War Illness (GWI), a multi-symptom chronic pain condition. Methods Forty GW veterans were recruited from across the US. Baseline measures included assessment of symptoms, myalgic score, tender point count, and dolorimetry. Subjects were randomized to the low glutamate diet, or to a wait-listed control group, starting the diet one month later. Measures were evaluated post-diet, and then subjects were randomized to a double-blind placebo-controlled crossover challenge with monosodium glutamate (MSG)/placebo to assess whether symptoms return/worsen in each condition. Challenge data have not yet been un-blinded, and thus are not included in this abstract. Symptom scores were compared between those randomized to immediate dietary intervention versus wait-listed controls (independent t-tests). After everyone completed the 1-month diet, change scores were analyzed for the whole group (Wilcoxon Signed Rank tests). Improvement was defined as ‘much’ or ‘very much’ improved on the patient global impression of change (PGIC) score, and the effect size was calculated (Cohen's d). Results After 1-month, overall symptom number (mean (SD)) significantly differed between the diet group (11(6)) and the wait-listed controls (18(6)), P = 0.0007. The diet had a very large effect size, d = 1.17, with no adverse effects reported. When comparing pre-post scores after all subjects followed the 1-month diet, the number of symptoms went from a mean(SD) of 21(5) at baseline to 12(6) post-diet, P < 0.0001. The severity of remaining symptoms was also significantly reduced (all P < 0.0001). Seventy-two % of subjects met the PGIC criteria for improvement. Highly significant improvements in pain measures were also observed for myalgic score (P < 0.0001), number of tender points (P < 0.0001), and average dolorimetry (P < 0.001). Conclusions These striking results suggest that the low glutamate diet may be an effective treatment for chronic pain and symptoms associated with Gulf War Illness. Funding Sources Department of Defense (DoD), US Army Medical Research Acquisition Activity, Office of the Assistant Secretary of Defense for Health Affairs through the GWI Research Program. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the DoD.

Characterizing the Placebo Response in Adults With ADHD

2018 ◽  
Vol 24 (3) ◽  
pp. 425-433 ◽  
Author(s):  
Joseph Ben-Sheetrit ◽  
Miriam Peskin ◽  
Jeffrey H. Newcorn ◽  
Yaron Daniely ◽  
Liat Shbiro ◽  
...  
Keyword(s):  
Retrospective Cohort ◽  
Adult Adhd ◽  
Rating Scale ◽  
Cohort Analysis ◽  
Placebo Response ◽  
Self Report ◽  
Double Blind ◽  
Retrospective Cohort Analysis ◽  
Current Sample

Objective: Several ADHD pharmacological trials reported high placebo response (PR) rates. This study aims to characterize the PR in adult ADHD. Method: A retrospective cohort analysis of the placebo arm (140 adults with ADHD, 18-55 yrs, M:F 46.4%-53.6%) of a 6-week randomized, multicenter, double-blind metadoxine study, using Conners’ Adult ADHD Rating Scale (CAARS) and the Adult ADHD Self-Report Scale (ASRS), was conducted. Results: Pre–post changes in placebo-treated adults were significant for both the CAARS and ASRS, F(2.9, 404.5) = 61.2, p < .00001, F(2.8, 383.0) = 43.1, p < .00001, respectively. Less than half of the participants had a PR which began early in treatment and persisted; almost 50% had a variable, inconsistent PR. Conclusion: In the current sample, PR in adult ADHD was prominent on both symptom scales and the investigator–rater instrument. Therefore, using investigator ratings as a primary endpoint does not necessarily attenuate PR. Of note, about half of the PR is variable, suggesting unreliable determination of efficacy.

scholarly journals Patient Adherence and Efficacy of Certolizumab Pegol in the Management of Crohn's Disease

2012 ◽  
Vol 5 ◽  
pp. CGast.S7613 ◽  
Author(s):  
Wojciech Blonski ◽  
Anna M. Buchner ◽  
Gary R. Lichtenstein
Keyword(s):  
Tumor Necrosis ◽  
Maintenance Treatment ◽  
Patient Adherence ◽  
Certolizumab Pegol ◽  
Controlled Trials ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Us ◽  
Necrosis Factor ◽  
Adherence To Therapy

Treatment with Anti-Tumor Necrosis Factor (anti-TNF) therapy has become a mainstay of therapy for patients with CD who are unresponsive to conventional medical management. Currently there are three anti-TNFα antibodies that have been approved by the US Food and Drug Administration for the treatment of CD, namely infliximab, adalimumab and certolizumab pegol (CZP). Several double blind placebo controlled trials determined that CZP is effective as induction and maintenance treatment in adult patients with CD regardless of their prior exposure to other anti-TNFα antibodies. This review discusses the efficacy of CZP and adherence to therapy with anti-TNFα antibodies in patients with CD.

scholarly journals 0763 Effects Of Solriamfetol On Driving Performance In Participants With Narcolepsy

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A290-A290
Author(s):  
F Vinckenbosch ◽  
G Lammers ◽  
S Overeem ◽  
D Chen ◽  
G Wang ◽  
...  
Keyword(s):  
Lateral Position ◽  
Driving Performance ◽  
Rank Test ◽  
Double Blind ◽  
Automobile Accidents ◽  
Signed Rank ◽  
Increased Risk ◽  
The Us ◽  
Norepinephrine Reuptake Inhibitor ◽  
Signed Rank Test

Abstract Introduction Patients with narcolepsy have an increased risk of automobile accidents. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the US (Sunosi®) for adults with excessive daytime sleepiness (EDS) associated with narcolepsy (75-150 mg/day). This study evaluated the effects of solriamfetol on on-road driving performance in participants with narcolepsy. Methods In each period of this randomized, double-blind, placebo-controlled, crossover study (NCT 02806908; EudraCT 2015-003931-36), driving performance during an on-road driving test (a 1-hour drive on a public highway) was assessed at 2 hours and 6 hours postdose following 7 days of treatment with solriamfetol (150 mg/day × 3, then 300 mg/day × 4) or placebo. For assessment of driving performance, the primary endpoint was standard deviation of lateral position (SDLP), a measure of “weaving,” at 2 hours postdose. Comparisons (solriamfetol vs placebo) used a Wilcoxon signed-rank test. Results The study included 24 participants (54% male; mean age, 40 years); 22 were included in the analyses of SDLP data. At 2 hours postdose, SDLP for solriamfetol (median, 19.08 cm) was statistically significantly lower than that for placebo (median, 20.46 cm; P=0.0022; incomplete driving tests: solriamfetol, n=4; placebo, n=7), indicating a better performance with solriamfetol. At 6 hours postdose, SDLP for solriamfetol (median, 19.59 cm) was not statistically significantly different from that for placebo (median, 19.78 cm; P=0.1245; incomplete driving tests: solriamfetol, n=3; placebo, n=10). Common adverse events (≥5%) were headache, decreased appetite, somnolence, sleep disorder, agitation, nausea, and palpitations. Conclusion Solriamfetol (300 mg/day) improved SDLP, an important measure of driving performance, at 2 hours after administration in participants with narcolepsy. Support Jazz Pharmaceuticals

Executive Functioning Outcomes Over 6 Months of Atomoxetine for Adults With ADHD: Relationship to Maintenance of Response and Relapse Over the Subsequent 6 Months After Treatment

2016 ◽  
Vol 24 (3) ◽  
pp. 363-372 ◽  
Author(s):  
Lenard A. Adler ◽  
Mary Solanto ◽  
Rodrigo Escobar ◽  
Sarah Lipsius ◽  
Himanshu Upadhyaya
Keyword(s):  
Executive Functioning ◽  
Adult Adhd ◽  
Rating Scale ◽  
Self Report ◽  
Symptom Improvement ◽  
Double Blind ◽  
Behavior Rating Inventory ◽  
The Relationship ◽  
Controlled Clinical Study

Objective: This study examines the relationship between maintenance of improved executive functioning (EF) in adults with ADHD with long-term symptom improvement with atomoxetine. Method: Data were collected from a yearlong, double-blind, placebo-controlled clinical study on adult patients with ADHD receiving atomoxetine (80-100 mg/day) for 24 weeks. Patients were then randomized to continue atomoxetine or placebo for 6 months. Executive functioning was rated with Behavior Rating Inventory of Executive Function–Adult Version: Self-Report™ (BRIEF-A: Self-Report™), and the T-scores were determined. Results: Postrandomization T-scores for atomoxetine patients were significantly better than those of placebo patients (3 and 6 months postrandomization). Patients with greater improvements in EF were more likely to show worsening of EF and to relapse after atomoxetine discontinuation. The maintenance of improved EF was significantly associated with improved ADHD symptoms (Conners’ Adult ADHD Rating Scale–Investigator Rated: Screening Version [CAARS-Inv:SV] with adult prompts). Conclusion: Treatment with atomoxetine improved EF during the treatment phases. Improved EF was maintained up to 6 months after discontinuation of atomoxetine.

scholarly journals Effects of MDMA on socioemotional feelings, authenticity, and autobiographical disclosure in healthy volunteers in a controlled setting

2015 ◽  
Author(s):  
Matthew J Baggott ◽  
Jeremy R Coyle ◽  
Jennifer D Siegrist ◽  
Kathleen J Garrison ◽  
Gantt P Galloway ◽  
...  
Keyword(s):  
Illicit Drug ◽  
Emotional Disclosure ◽  
Negative Evaluation ◽  
Self Report ◽  
Controlled Study ◽  
Social Emotions ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Interpersonal Closeness ◽  
Within Subjects

The drug 3,4-methylenedioxymethamphetamine (MDMA, ?ecstasy?, ?molly?) is a widely used illicit drug and experimental adjunct to psychotherapy. MDMA has unusual, poorly understood socioemotional effects, including feelings of interpersonal closeness and sociability. To better understand these effects, we conducted a within-subjects double-blind placebo controlled study of the effects of 1.5 mg/kg oral MDMA on social emotions and autobiographical disclosure in a controlled setting. MDMA displayed both sedative- and stimulant-like effects, including increased self-report anxiety. At the same time, MDMA positively altered evaluation of the self (i.e., increasing feelings of authenticity) while decreasing concerns about negative evaluation by others (i.e., decreasing social anxiety). Consistent with these feelings, MDMA increased how comfortable participants felt describing emotional memories. Overall, MDMA produced a prosocial syndrome that seemed to facilitate emotional disclosure and that appears consistent with the suggestion that it represents a novel pharmacological class.

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