scholarly journals Impact of Fatty Acid Supplementation on Cognitive Performance among United States (US) Military Officers: The Ranger Resilience and Improved Performance on Phospholipid-Bound Omega-3’s (RRIPP-3) Study

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1854
Author(s):  
Bernadette P. Marriott ◽  
Travis H. Turner ◽  
Joseph R. Hibbeln ◽  
Jill C. Newman ◽  
Marcie Pregulman ◽  
...  
Keyword(s):  
United States ◽  
Controlled Trial ◽  
The United States ◽  
Military Officers ◽  
Krill Oil ◽  
Omega 3 ◽  
Double Blind ◽  
Significant Group ◽  
Intention To Treat ◽  
Improved Performance

Studies have assessed omega-3 fatty acids and cognitive decline among older adults and cognitive development among children, although less is known about cognitive or neurological effects among young adults. We examined whether omega-3 supplementation from krill oil could improve cognition and resilience among young military officers compared to a control. This double-blind, placebo-controlled trial enrolled 555 officers (mean age 23.4 ± 2.8, 98.6% male) entering the United States (US) Army Infantry Basic Officer Leaders Course (IBOLC) with the intention to complete the US Ranger Course. Volunteer participants consumed eight dietary supplements daily of krill oil containing 2.3 g omega-3 or control (macadamia nut oil) over an approximate 20-week period. Cognitive functioning, resilience, and mood were assessed during a well-rested period at approximately 14 weeks and after a battlefield simulation at 16 weeks. Blood spot samples were collected to monitor compliance and dietary intake was assessed. All hypotheses were tested using both ‘Intention to Treat’ (ITT) and ‘As Per Protocol’ (APP) approaches. Of the 555 randomized individuals, 245 (44.1%) completed the study. No statistically significant group-by-time interactions indicating treatment effect were found on any outcomes. Poor compliance was indicated by lower than expected omega-3 elevations in the treatment group, and may have contributed to a failure to detect a response.

scholarly journals Daily Lactobacillus Probiotic versus Placebo in COVID-19-Exposed Household Contacts (PROTECT-EHC): A Randomized Clinical Trial

2022 ◽  
Author(s):  
Paul E Wischmeyer ◽  
Helen Tang ◽  
Yi Ren ◽  
Lauren Bohannon ◽  
Zeni E Ramirez ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
The United States ◽  
Post Exposure Prophylaxis ◽  
Event Analysis ◽  
Double Blind ◽  
Intention To Treat ◽  
Tract Infections ◽  
Exposure Prophylaxis ◽  
Vaccine Availability

Background: The COVID-19 pandemic continues to pose unprecedented challenges to worldwide health. While vaccines are effective, supplemental strategies to mitigate the spread and severity of COVID-19 are urgently needed. Emerging evidence suggests susceptibility to infections, including respiratory tract infections, may be reduced by probiotic interventions. Therefore, probiotics may be a low-risk, widely implementable modality to mitigate risk of COVID-19 disease, particularly in areas with low vaccine availability and/or uptake. Methods: We conducted a randomized, double-blind, placebo-controlled trial across the United States testing the probiotic Lactobacillus rhamnosus GG (LGG) as post-COVID-19-exposure prophylaxis. We enrolled individuals > 1 year of age with a household contact with a recent (≤ 7 days) diagnosis of COVID-19. Participants were randomized to receive daily LGG or placebo for 28 days. Stool was collected to evaluate the microbiome. The primary outcome was development of symptoms of illness compatible with COVID-19 within 28 days. Findings: We enrolled 182 COVID-19-exposed participants. Intention-to-treat analysis showed that participants randomized to LGG were less likely to develop symptoms versus those randomized to placebo (26.4% vs. 42.9%, p=0.02). Further, LGG was associated with a statistically significant reduction in COVID-19 diagnosis (log rank p=0.049) via time-to-event analysis. Overall incidence of COVID-19 diagnosis was not significantly different between LGG (8.8%) and placebo (15.4%) (p=0.17). LGG was well-tolerated with no increased side effects versus placebo. Interpretation: These findings suggest that LGG probiotic may protect against the development of COVID-19 infection and symptoms when used as post-exposure prophylaxis within 7 days after exposure. Funding: This work was supported by a grant from the Duke Microbiome Center to A.D.S. and P.E.W. and private philanthropic donations to A.D.S. DSM/iHealth donated the LGG and placebo for the trial but had no role in its design, conduct, analysis, or writing. Trial registration: NCT04399252

scholarly journals Effect of 1 Year Krill Oil Supplementation on Cognitive Achievement of Dutch Adolescents: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1230 ◽  
Author(s):  
Inge S.M. van der Wurff ◽  
Clemens von Schacky ◽  
Trygve Bergeland ◽  
Roeslan Leontjevas ◽  
Maurice P. Zeegers ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Repeated Measurements ◽  
Krill Oil ◽  
Omega 3 ◽  
Double Blind ◽  
Neurocognitive Tests ◽  
Neurocognitive Test ◽  
Intervention Trials ◽  
One Year ◽  
And Function

Long-chain polyunsaturated fatty acids (LCPUFA) are important for brain development and function, maybe especially during adolescence. Observational studies have demonstrated an association between fish consumption (a source of LCPUFA) and cognition in adolescents, but intervention trials are lacking. The goal of the current study was to investigate the effect of one year of krill oil (a source of LCPUFA) supplementation on the cognitive performance of adolescents with a low Omega-3 Index (O3I ≤ 5%). A double-blind, randomized, and placebo-controlled supplementation trial with repeated measurements (baseline (T0), three months (T1), six months (T2), and 12 months (T3)) in adolescents (267 randomized) was executed. Participants were randomized to 400 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) per day in Cohort I or placebo and 800 mg EPA + DHA per day in Cohort II or placebo. O3I was monitored by a finger prick at all time points. At T0, T2, and T3, participants executed a neurocognitive test battery. Covariate corrected mixed models were run with either condition (krill or placebo) or O3I as predictors. Krill oil supplementation led to a small but significant increase in mean O3I, but few participants increased to the intended O3I range (8–11%). There was no significant effect of supplementation on the neurocognitive tests, nor a relationship between O3I and neurocognitive test scores. The increase in O3I was small in most participants, probably due to non-compliance. Possibly the increase in O3I was too small to demonstrate an effect. More research on the influence of LCPUFAs on cognition in adolescents is needed.

When, If Ever, Is It Ethical to Do Research in Developing Countries That Could Not Be Done Ethically in Developed Countries?

2018 ◽  
pp. 122-144
Author(s):  
Lainie Friedman Ross
Keyword(s):  
United States ◽  
Developing Countries ◽  
Controlled Trial ◽  
Perinatal Transmission ◽  
Developed Countries ◽  
The United States ◽  
Haemophilus Influenzae Type ◽  
Haemophilus Influenzae Type B ◽  
Double Blind ◽  
Double Blind Placebo

In this chapter, three studies performed in the 1990s in three developing countries focused on three neonatal infectious diseases are discussed. The studies were (a) a randomized, double-blind, placebo-controlled trial to reduce perinatal transmission of HIV in Thailand; (b) a randomized, double-blind, placebo-controlled trial to prevent Haemophilus influenzae type b pneumonia in infants in The Gambia; and (c) a nonrandomized cluster trial to reduce neonatal mortality rate from sepsis in infants born at home in India. The chapter examines the ethical controversies raised by these studies and concludes that location and intention matter. Although these studies could not have been performed in the United States or United Kingdom, they were designed to answer a question relevant to the community in which the research was being conducted. Finally, the chapter explores the different ethical scrutiny these studies received and what lessons can be learned.

Effectiveness of the Fun for Wellness Online Behavioral Intervention to Promote Well-Being Actions in Adults With Obesity or Overweight: A Randomized Controlled Trial

2020 ◽  
pp. 1-14
Author(s):  
Seungmin Lee ◽  
Adam McMahon ◽  
Isaac Prilleltensky ◽  
Nicholas D. Myers ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
United States ◽  
Randomized Controlled Trial ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
The United States ◽  
Three Dimensions ◽  
Double Blind ◽  
Randomized Controlled ◽  
Parallel Group

The purpose of this study was to evaluate the effectiveness of the Fun For Wellness (FFW) online intervention to increase well-being actions in adults with obesity in the United States in relatively uncontrolled settings. The FFW intervention is guided by self-efficacy theory. The study design was a large-scale, prospective, double-blind, and parallel-group randomized controlled trial. Data collection occurred at baseline, 30 days after baseline, and 60 days after baseline. Participants (N = 667) who were assigned to the FFW group (nFFW = 331) were provided with 30 days of 24-hr access to FFW. Supportive evidence was provided for the effectiveness of FFW in real-world settings to promote, either directly or indirectly, three dimensions of well-being actions: community, occupational, and psychological. This study shows that theory-based intervention may be effective in promoting well-being actions in adults with obesity in the United States.

Rotigotine improves restless legs syndrome: A 6-month randomized, double-blind, placebo-controlled trial in the United States

2010 ◽  
Vol 25 (11) ◽  
pp. 1675-1683 ◽  
Author(s):  
Wayne A. Hening ◽  
Richard P. Allen ◽  
William G. Ondo ◽  
Arthur S. Walters ◽  
John W. Winkelman ◽  
...  
Keyword(s):  
United States ◽  
Restless Legs Syndrome ◽  
Controlled Trial ◽  
The United States ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Restless Legs

scholarly journals The aspirin in reducing events in the elderly trial: Statistical analysis plan

2017 ◽  
Vol 13 (3) ◽  
pp. 335-338 ◽  
Author(s):  
Rory Wolfe ◽  
Anne M Murray ◽  
Robyn L Woods ◽  
Brenda Kirpach ◽  
David Gilbertson ◽  
...  
Keyword(s):  
United States ◽  
Statistical Analysis ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The United States ◽  
Statistical Analysis Plan ◽  
Sensitivity Analyses ◽  
Double Blind ◽  
Age Related

Rationale Aspirin has positive and negative effects on a number of age-related chronic conditions and there is uncertainty regarding its role in primary prevention in people aged 70 years and over. Aims To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants. Design A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke. Study outcome In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person. Discussion The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses. (International Standard Randomized Controlled Trial Number Register ISRCTN83772183 and clinicaltrials.gov Number NCT01038583)

scholarly journals Increase of Dose Associated With Decrease in Protection Against Controlled Human Malaria Infection by PfSPZ Vaccine in Tanzanian Adults

2019 ◽  
Vol 71 (11) ◽  
pp. 2849-2857 ◽  
Author(s):  
Said A Jongo ◽  
L W Preston Church ◽  
Ali T Mtoro ◽  
Tobias Schindler ◽  
Sumana Chakravarty ◽  
...  
Keyword(s):  
United States ◽  
Malaria Infection ◽  
Controlled Trial ◽  
Quantitative Polymerase Chain Reaction ◽  
The United States ◽  
Double Blind ◽  
Human Malaria ◽  
Cell Responses ◽  
Controlled Human Malaria Infection ◽  
Ideal Tool

Abstract Background A vaccine would be an ideal tool for reducing malaria’s impact. PfSPZ Vaccine (radiation attenuated, aseptic, purified, cryopreserved Plasmodium falciparum [Pf] sporozoites [SPZ]) has been well tolerated and safe in >1526 malaria-naive and experienced 6-month to 65-year-olds in the United States, Europe, and Africa. When vaccine efficacy (VE) of 5 doses of 2.7 × 105 PfSPZ of PfSPZ Vaccine was assessed in adults against controlled human malaria infection (CHMI) in the United States and Tanzania and intense field transmission of heterogeneous Pf in Mali, Tanzanians had the lowest VE (20%). Methods To increase VE in Tanzania, we increased PfSPZ/dose (9 × 105 or 1.8 × 106) and decreased numbers of doses to 3 at 8-week intervals in a double blind, placebo-controlled trial. Results All 22 CHMIs in controls resulted in parasitemia by quantitative polymerase chain reaction. For the 9 × 105 PfSPZ group, VE was 100% (5/5) at 3 or 11 weeks (P < .000l, Barnard test, 2-tailed). For 1.8 × 106 PfSPZ, VE was 33% (2/6) at 7.5 weeks (P = .028). VE of dosage groups (100% vs 33%) was significantly different (P = .022). Volunteers underwent repeat CHMI at 37–40 weeks after last dose. 6/6 and 5/6 volunteers developed parasitemia, but time to first parasitemia was significantly longer than controls in the 9 × 105 PfSPZ group (10.89 vs 7.80 days) (P = .039), indicating a significant reduction in parasites in the liver. Antibody and T-cell responses were higher in the 1.8 × 106 PfSPZ group. Conclusions In Tanzania, increasing the dose from 2.7 × 105 to 9 × 105 PfSPZ increased VE from 20% to 100%, but increasing to 1.8 × 106 PfSPZ significantly reduced VE. Clinical Trials Registration NCT02613520.

scholarly journals A Randomized, Double-Blind Controlled Trial of Lumbar Interlaminar Epidural Injections in Central Spinal Stenosis: 2-Year Follow-Up

2015 ◽  
Vol 18;1 (1;1) ◽  
pp. 79-92
Author(s):  
Laxmaiah Manchikanti
Keyword(s):  
United States ◽  
Low Back Pain ◽  
Back Pain ◽  
Spinal Stenosis ◽  
Local Anesthetic ◽  
Controlled Trial ◽  
The United States ◽  
Low Back ◽  
Double Blind ◽  
Epidural Injections

Background: While low back pain is the number one cause of disability in the United States, lumbar spinal stenosis along with intervertebral disc herniation and degenerative spondylolisthesis is one of the 3 most common diagnosis of low back and leg pain for which surgery is performed. Numerous modalities of treatments including drug therapy and complex surgical fusions have been recommended for treatment of central spinal stenosis. Epidural injections are one of the commonly performed nonsurgical interventions in managing central spinal stenosis; however, there has been paucity of literature in reference to efficacy of epidural injections in managing central spinal stenosis with lumbar interlaminar epidural injections. Study Design: A randomized, double-blind, active controlled trial. Setting: Private interventional pain management practice and specialty referral center in the United States. Objective: To assess the effectiveness of lumbar interlaminar epidural injections with or without steroids in providing effective and long-lasting pain relief with improvement in functional status for the management of chronic low back and lower extremity pain related to lumbar central spinal stenosis. Methods: A randomized, double-blind, active-control trial was designed with the inclusion of 120 patients assigned to 2 groups. Group I patients received lumbar interlaminar epidural injections of local anesthetic (lidocaine 0.5%) 6 mL, whereas Group II received lumbar interlaminar epidural injections with local anesthetic (lidocaine 0.5%) 5 mL mixed with 1 mL of steroids and 6 mg of betamethasone. Outcomes Assessment: Outcomes were assessed utilizing the numeric pain rating scale (NRS) and Oswestry Disability Index (ODI) at 3, 6, 12, 18, and 24 months post treatment. The primary outcome measure was significant improvement, defined as 50% improvement in pain and disability scores. Results: Significant relief and functional status improvement was seen in 72% and 73% of patients in Groups I and II at the end of 2 years considering all participants; however, this was 84% and 85% in the successful group. Overall significant improvement was achieved for 65.7 ± 37.3 weeks in Group 1 and 68.9 ± 37.7 weeks in Group II at the end of 2 years when all participants were considered; whereas, this was 77 ± 27.8 weeks and 77.9 ± 30.2 weeks when they were separated into successful categories. The average number of procedures per patient was 5 to 6 in both groups. Limitations: Limitations of this trial include lack of placebo control group and treatment of patients with multiple procedures over a period of 2 years. Conclusion: Lumbar interlaminar epidural injections of local anesthetic with or without steroids provide relief in a significant proportion of patients with lumbar central spinal stenosis. Key words: Chronic low back pain, lower extremity pain, central spinal stenosis, interlaminar epidural injections, caudal epidural injections, steroids, local anesthetics, placebo, active control

A Consumer’s Guide to Eggs

EDIS ◽  
2013 ◽  
Vol 2013 (11) ◽  
Author(s):  
Jeanine Beatty ◽  
Karla Shelnutt ◽  
Gail P. A. Kauwell
Keyword(s):  
United States ◽  
Fatty Acid ◽  
New World ◽  
The United States ◽  
Omega 3 ◽  
Bottom Line ◽  
Christopher Columbus ◽  
Food Stores ◽  
Omega 3 Fatty Acid ◽  
Chicken Eggs

People have been eating eggs for centuries. Records as far back as 1400 BC show that the Chinese and Egyptians raised birds for their eggs. The first domesticated birds to reach the Americas arrived in 1493 on Christopher Columbus' second voyage to the New World. Most food stores in the United States offer many varieties of chicken eggs to choose from — white, brown, organic, cage free, vegetarian, omega-3 fatty acid enriched, and more. The bottom line is that buying eggs is not as simple as it used to be because more choices exist today. This 4-page fact sheet will help you understand the choices you have as a consumer, so you can determine which variety of egg suits you and your family best. Written by Jeanine Beatty, Karla Shelnutt, and Gail Kauwell, and published by the UF Department of Family Youth and Community Sciences, November 2013. http://edis.ifas.ufl.edu/fy1357

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