A Modified MCT-Based Ketogenic Diet Increases Plasma ß-Hydroxybutyrate but Has Less Effect on Fatigue and Quality of Life in People with Multiple Sclerosis Compared to a Modified Paleolithic Diet: A Waitlist-Controlled, Randomized Pilot Study.

OBJECTIVE: To investigate the feasibility of a modified MCT-based ketogenic diet and its impact on plasma ß-hydroxybutyrate and MS outcomes compared to a modified Paleolithic diet and usual diet in people with Multiple Sclerosis (MS). METHODS: Fifteen individuals with MS were randomized to 3 groups: 1) modified Paleolithic diet (Paleo; n = 6); 2) medium-chain triglyceride (MCT)-based ketogenic diet that included coconut as a fat source (Keto; n = 5); or 3) usual diet (Control; n = 4). Participants had blood drawn every 4 weeks to monitor nutritional ketosis. Participants completed 4-day weighed food records, measures of disability, fatigue, quality of life (QoL), cognitive function, and physical function at baseline and 12-weeks. RESULTS: Macronutrient intake significantly shifted toward a ratio indicative of a ketogenic diet in the Keto group at 12 weeks. Similarly, plasma ß-hydroxybutyrate indicated nutritional ketosis in the Keto group, whereas neither macronutrient intake nor plasma ß-hydroxybutyrate indicated nutritional ketosis in the Paleo and Control groups. The Paleo group had significant within group reductions in fatigue scores and maintained cognitive function scores compared to the Control group. The Keto group had significant reductions in fasting glucose and insulin compared to baseline values; however, no clinical outcomes significantly changed. CONCLUSIONS: Participants consuming the MCT-based ketogenic diet achieved nutritional ketosis; however, it was not associated with significant clinical improvement in this study whereas the modified Paleolithic diet was associated with significant clinical improvements. Larger randomized controlled trials are needed to determine the safety and efficacy of the modified Paleolithic and MCT-based ketogenic diets on MS.

Open fire ovens and effects of in-home lavash bread baking on carbon monoxide exposure and carboxyhemoglobin levels among women in rural Armenia.

Lavash is a traditional flatbread commonly baked at home by women in Armenia and other Middle Eastern and Caucasus countries. The baking process follows centuries' old recipes and is done primarily in open fire ovens. Data are limited regarding the impact of baking on indoor air quality and health outcomes. This study aimed at assessing the effects of lavash baking on household air pollution and cardiovascular outcomes among women who bake lavash in rural Armenia. A convenience sample of 98 bakers, all women, never-smokers, representing 36 households were enrolled. Carbon monoxide (CO) concentrations and carboxyhemoglobin (COHb) levels were monitored before, during, and/or after baking. As expected, exposure to concentrations of CO peaking at/or above 35-ppm during baking was more likely to occur in homes with fully enclosed and poorly ventilated baking rooms, compared to those with three or fewer walls and/or one or more windows. Bakers in homes where CO concentrations peaked at/or above 35-ppm were more likely to have an increase in post-baking COHb levels compared to those in homes with lower CO concentrations.

A Multimodal, Nonpharmacologic Intervention Improves Mood and Cognitive Function in People with Multiple Sclerosis.

OBJECTIVE: The objective of this study was to examine whether participation in a 12-month multimodal intervention would improve mood and cognitive function in adults with progressive multiple sclerosis (MS). METHODS: In this one-arm, open-label feasibility trial, participants were prescribed a home-based multimodal intervention, including (1) a modified Paleolithic diet; (2) an exercise program (stretching and strengthening of the trunk and lower limb muscles); (3) neuromuscular electrical stimulation (EStim) of trunk and lower limb muscles; and (4) stress management (meditation and self-massage). Individuals completed measures of mood (Beck Anxiety and Depression Inventories) and cognitive (Cognitive Stability Index, Cognitive Screening Test, Delis-Kaplan Executive Function System) and executive function (Wechsler Adult Intelligence Scale) at baseline and 3, 6, 9, and 12 months after the start of the intervention. Dosage of the multimodal intervention was assessed at 3, 6, 9, and 12 months. RESULTS: The more individuals participated in the intervention activities, the greater improvements they had from baseline to 12 months on self-report measures of anxiety (Beck Anxiety Inventory [BAI]; ps = 0.001 to 0.02), depression (Beck Depression Inventory [BDI]; ps = <0.0001 to 0.09), cognitive function (Cognitive Stability Index [CSI/T], Delis-Kaplan Executive Function System [DKEFS]; ps = 0.001 to 0.06), and executive function (Wechsler Adult Intelligence Scale [WAIS]; ps = <0.0001 to 0.09). Mood and cognitive improvements were more closely related to a higher intake of the modified Paleolithic diet than to exercise and stress management dosage. Anxiety and depression changes were evident after just a few months, whereas changes in cognitive function were generally not observed until later in the intervention period. Mood and cognitive function changes from baseline to 12 months were significantly associated with fatigue improvements (ps = <0.0001 to 0.03). CONCLUSIONS: A modified Paleolithic diet, exercise, EStim, and stress management intervention like this one has the potential to improve the mood and cognitive symptoms that can lead to considerable suffering in people with MS, potentially improving quality of life and function for people with progressive MS.

Inside the nation's largest mental health institution: a prevalence study in a state prison system.

BACKGROUND: The United States has the highest incarceration rate in the world which has created a public health crisis. Correctional facilities have become a front line for mental health care. Public health research in this setting could inform criminal justice reform. We determined prevalence rates for mental illnesses and related comorbidities among all inmates in a state prison system. METHODS: Cross-sectional study using the Iowa Corrections Offender Network which contains health records of all inmates in Iowa. The point prevalence of both ICD-9 and DSM-IV codes for mental illnesses, timing of diagnosis and interval between incarceration and mental illness diagnosis were determined. RESULTS: The average inmate (N = 8574) age was 36.7 ± 12.4 years; 17% were ≥50 years. The majority of inmates were men (91%) and white (65%).Obesity was prevalent in 38% of inmates, and 51% had a history of smoking. Almost half of inmates were diagnosed with a mental illness (48%), of whom, 29% had a serious mental illness (41% of all females and 27% of all males), and 26% had a history of a substance use disorder. Females had higher odds of having both a mental illness and substance use disorder. Almost all mental illness diagnoses were first made during incarceration (99%). The mean interval to diagnosis of depression, anxiety, PTSD and personality disorders were 26, 24, 21 and 29 months respectively. Almost 90% of mental illnesses were recognized by the 6th year of incarceration. The mean interval from incarceration to first diagnosis (recognition) of a substance abuse history was 11 months. CONCLUSIONS: There is a substantial burden of mental illness among inmates. Racial, age and gender disparities in mental health care are coupled with a general delay in diagnosis and treatment. A large part of understanding the mental health problem in this country starts at prisons.

Diet drink consumption and the risk of cardiovascular events: a report from the Women's Health Initiative.

BACKGROUND: Data are limited regarding the influence of diet drink consumption on cardiovascular disease (CVD) outcomes. OBJECTIVE: We aimed to evaluate the relationship between diet drink intake and cardiovascular events. DESIGN: We conducted a retrospective cohort study, utilizing data from the national, multicenter Women's Health Initiative Observational Study (WHI OS), recruiting subjects from 1993 to 1998. PATIENTS: Post-menopausal women with available diet drink intake data, without pre-existing CVD and who survived ≥ 60 days were included in the study. MAIN MEAURES: A composite of incident coronary heart disease, heart failure, myocardial infarction, coronary revascularization procedure, ischemic stroke, peripheral arterial disease and CVD death was used as the primary outcome. CVD death and all-cause mortality were secondary outcomes. Adjusted Cox proportional hazards models were used to compare primary and secondary outcomes across diet drink intake strata. KEY RESULTS: In all, 59,614 women, mean age 62.8 years, were included for analysis. In unadjusted analysis over a follow-up of 8.7 ± 2.7 years, the primary outcome occurred in 8.5 % of the women consuming ≥ 2 diet drinks/day, compared to 6.9 %, 6.8 % and 7.2 % in the 5-7/week, 1-4/week and 0-3/month groups, respectively. After controlling for other CVD risk factors, women who consumed ≥ 2 drinks/day had a higher adjusted risk of CVD events (HR 1.3, 95 % CI 1.1-1.5), CVD mortality (HR 1.5, 95 % CI 1.03-2.3) and overall mortality (HR 1.3, 95 % CI 1.04-1.5) compared to the reference group (0-3 drinks/month). CONCLUSIONS: This analysis demonstrates an association between high diet drink intake and CVD outcomes and mortality in post-menopausal women in the WHI OS.

Preparedness for natural disasters among older US adults: a nationwide survey.

OBJECTIVES: We sought to determine natural disaster preparedness levels among older US adults and assess factors that may adversely affect health and safety during such incidents. METHODS: We sampled adults aged 50 years or older (n = 1304) from the 2010 interview survey of the Health and Retirement Study. The survey gathered data on general demographic characteristics, disability status or functional limitations, and preparedness-related factors and behaviors. We calculated a general disaster preparedness score by using individual indicators to assess overall preparedness. RESULTS: Participant (n = 1304) mean age was 70 years (SD = 9.3). Only 34.3% reported participating in an educational program or reading materials about disaster preparation. Nearly 15% reported using electrically powered medical devices that might be at risk in a power outage. The preparedness score indicated that increasing age, physical disability, and lower educational attainment and income were independently and significantly associated with worse overall preparedness. CONCLUSIONS: Despite both greater vulnerability to disasters and continuous growth in the number of older US adults, many of the substantial problems discovered are remediable and require attention in the clinical, public health, and emergency management sectors of society.

Preparedness for natural disasters among older US adults: a nationwide survey.

OBJECTIVES: We sought to determine natural disaster preparedness levels among older US adults and assess factors that may adversely affect health and safety during such incidents. METHODS: We sampled adults aged 50 years or older (n = 1304) from the 2010 interview survey of the Health and Retirement Study. The survey gathered data on general demographic characteristics, disability status or functional limitations, and preparedness-related factors and behaviors. We calculated a general disaster preparedness score by using individual indicators to assess overall preparedness. RESULTS: Participant (n = 1304) mean age was 70 years (SD = 9.3). Only 34.3% reported participating in an educational program or reading materials about disaster preparation. Nearly 15% reported using electrically powered medical devices that might be at risk in a power outage. The preparedness score indicated that increasing age, physical disability, and lower educational attainment and income were independently and significantly associated with worse overall preparedness. CONCLUSIONS: Despite both greater vulnerability to disasters and continuous growth in the number of older US adults, many of the substantial problems discovered are remediable and require attention in the clinical, public health, and emergency management sectors of society.

Medication therapy management and complex patients with disability: a randomized controlled trial.

BACKGROUND: Drug therapy problems, adverse drug events (ADEs), and symptom burden are high among adults with disabilities. OBJECTIVE: To compare the effects of a modified medication therapy management (MTM) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations. METHODS: Three-group randomized controlled trial among adults (age 40 and older) with self-reported activity limitations in community practice. INTERVENTIONS: 8 weekly Living Well With a Disability (LWD) 2-hour workshop sessions with and without a collaborative medication management (CMM) module. PRIMARY OUTCOME: mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms. Process measures: changes in medication regimens and self-reported ADEs. ANALYSIS: general linear mixed models (continuous outcomes) and generalized estimating equations (categorical outcomes). RESULTS: Participants had high symptom burden, low physical health, and took many medications. There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups (Study group × Time P = .014), and there were significantly more changes in medication regimens in the LWD + CMM group (P = .013 LWD only vs LWD + CMM). The oldest third of participants had significantly fewer mean symptoms but received more intense CMM. There was no difference between the LWD-only, LWD + CMM, and usual care groups in symptom burden over time. CONCLUSION: Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations.

Assessment of dietary adequacy for important brain micronutrients in patients presenting to a traumatic brain injury clinic for evaluation.

OBJECTIVE: To evaluate dietary adequacy of patients presenting for evaluation at an outpatient traumatic brain injury (TBI) clinic. METHODS: We identified 14 key micronutrients with defined dietary intake reference ranges that are considered important for brain health. Adult patients completed the Brief NutritionQuest Food Frequency Questionnaire (FFQ) to calculate estimated nutrient intake. Medical records were abstracted for diagnoses, body mass index, and neurobehavioral subscale scores. Nutrients were assessed individually and were also summarized into a summary score. Associations between individual nutrients, summary nutrient intake, and neurobehavioral scores were assessed. RESULTS: A total of 39 FFQs were completed by subjects, and 25 (64%) had recorded neurobehavioral scores. No subjects met the recommended dietary allowances (RDAs) for all 14 micronutrients. Ten (26%) met the RDAs for 6 or fewer nutrients, and 10 met the RDAs for 11-12 nutrients. Of 12 nutrients with sufficient sample size for analysis, 11 (92%) were associated with worse mean somatic scores, 9 (75%) were associated with worse cognitive scores, and 8 (67%) were linked with worse affective scores for those with the lowest nutrient intake compared with those who had the highest intake. However, only four nutrients were statistically associated with the somatic mean score: folate (P = 0.010), magnesium (P = 0.082), vitamin C (P = 0.021), and vitamin K (P = 0.024). None were linked with cognitive or affective scores. DISCUSSION: Diets failing to meet RDAs for important brain nutrients were common in an outpatient TBI clinic, with the worst mean neurobehavioral scores for those patients not meeting the estimated average requirements.

[Preparedness for natural disasters among older US adults: a nationwide survery]. / Preparación de los adultos mayores en los Estados Unidos para hacer frente a los desastres naturales: encuesta a escala nacional.

OBJECTIVES: We sought to determine natural disaster preparedness levels among older US adults and assess factors that may adversely affect health and safety during such incidents. METHODS: We sampled adults aged 50 years or older (n = 1 304) from the 2010 interview survey of the Health and Retirement Study. The survey gathered data on general demographic characteristics, disability status or functional limitations, and preparedness-related factors and behaviors. We calculated a general disaster preparedness score by using individual indicators to assess overall preparedness. RESULTS: Participant (n = 1 304) mean age was 70 years (SD = 9.3). Only 34.3% reported participating in an educational program or reading materials about disaster preparation. Nearly 15% reported using electrically powered medical devices that might be at risk in a power outage. The preparedness score indicated that increasing age, physical disability, and lower educational attainment and income were independently and significantly associated with worse overall preparedness. CONCLUSIONS: Despite both greater vulnerability to disasters and continuous growth in the number of older US adults, many of the substantial problems discovered are remediable and require attention in the clinical, public health, and emergency management sectors of society.

Association Between Improved Serum Fatty Acid Profiles and Cognitive Function During a Dietary Intervention Trial in Relapsing-Remitting Multiple Sclerosis.

BACKGROUND: Cognitive impairment is a common multiple sclerosis (MS)-related symptom that impacts quality of life (QOL). Diet interventions are shown to be beneficial in managing QOL, and the intake of essential fatty acids is linked with improved cognitive function. However, the effect of diets on serum fatty acid profiles and cognitive function is unknown. METHODS: A previous randomized, parallel-arm trial recruited participants with relapsing-remitting MS (N = 77). Study visits included 4 time points: run-in, baseline, 12 weeks, and 24 weeks. During the run-in phase, participants followed their usual diet and were then randomly assigned to either a modified paleolithic (Wahls) or a low saturated fat (Swank) diet at baseline. Assessments at study visits included cognitive function assessed by Symbol Digit Modalities Test-Oral (SDMT-O) and Perceived Deficits Questionnaire (PDQ), and serum fatty acids, including eicosapentaenoic (EPA), docosahexaenoic (DHA), and arachidonic (ARA) acids. RESULTS: Both groups had significant improvements in all serum fatty acids (P < .01), except for ARA, as well as SDMT-O at 24-weeks (P < .05), total PDQ at 12 and 24 weeks (P < .01) compared with baseline values. The 12-week changes in ω-3 (EPA + DHA) index and EPA serum fatty acids were associated with SDMT-O changes (P ≤ .05); however, the changes in fatty acid levels did not mediate the effect of the diets on SDMT-O or PDQ (P > .05). CONCLUSIONS: Both diets led to improvements in serum fatty acid profiles and cognitive function, with associations between the 12-week ω-3 (EPA + DHA) index and EPA changes with SDMT-O.

Diet-Induced Changes in Functional Disability among People with Multiple Sclerosis: A Secondary Pooled Analysis of Two Randomized Controlled Pilot Trials.

Emerging evidence links dietary interventions to favorable multiple sclerosis (MS) outcomes; however, evidence for the efficacy of dietary interventions on functional disability remains sparse. Data from two 12-week, randomized, controlled pilot trials were pooled to investigate the efficacy of a modified Paleolithic diet (Paleo) on functional disability, as assessed by the MS Functional Composite (MSFC), among people diagnosed with MS. Pooled baseline-referenced MSFC scores were calculated from the nine-hole peg test (NHPT), timed 25-foot walk (T25FW), and Paced Auditory Serial Addition Test (PASAT) Z-scores. There was no significant difference in the mean change in MSFC scores between groups (p = 0.07). In the Paleo group, a significant increase was observed in the MSFC scores (p = 0.03), NHPT (p < 0.001), and PASAT (p = 0.04) Z-scores at 12 weeks, indicating reduced functional disability compared to baseline values. No significant changes were observed within the Control group. Study-specific differences in the MSFC changes between groups were observed. Functional disability was reduced compared to the baseline in the Paleo group, possibly depending on MS type. These results provide preliminary observations on the efficacy of a modified Paleolithic diet for reducing or maintaining functional disability in MS.

Effects of a Remote Multimodal Intervention Involving Diet, Walking Program, and Breathing Exercise on Quality of Life Among Newly Diagnosed People with Multiple Sclerosis: A Quasi-Experimental Non-Inferiority Pilot Study.

Background: Interventions involving diet, physical activity, and breathing exercises are shown to be beneficial in managing both fatigue and quality of life (QoL) related to MS; however, the impact of such interventions among people newly diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) who decline disease-modifying therapies (DMTs) is unknown. Methods: A 12-month prospective quasi-experimental non-inferiority trial recruited people newly diagnosed with CIS or RRMS who voluntarily declined DMTs (health behavior group; HB, n = 29) or followed standard of care (SOC, n = 15). Participants in the HB group were remotely coached on the study diet, moderate-intensity walking, and breathing exercises. All participants completed questionnaires validated to assess MS symptoms, including perceived mental and physical QoL (MSQOL54); fatigue (Fatigue Severity Scale, FSS; and Modified Fatigue Impact Scale, MFIS); mood (Hospital Anxiety and Depression Scale, HADS); and cognitive function (Perceived Deficits Questionnaire, PDQ). Results: During the 12 months, the HB group experienced improvement in scores for mental QoL (MSQOL54 - Mental, 0.24, 95% CI 0.01, 0.47; p = 0.04), fatigue (Total MFIS, -7.26, 95% CI -13.3,-1.18; p = 0.02), and perceived cognitive function (Total PDQ, PDQ-Attention, PDQ-Promemory, and PDQ-Planning, p ≤ 0.03 for all). A between-group difference was observed only for PDQ-Planning (p = 0.048). Non-inferiority analysis revealed that the 12-month changes in means for the HB group were not worse than those for the SOC group with respect to fatigue (FSS, p = 0.02), mood (HDS-Anxiety, p = 0.02; HADS-Depression, p < 0.0001), physical QoL (MSQOL54 - Physical, p = 0.02), or cognitive dysfunction (Total PDQ, p = 0.01). Conclusion: The multimodal lifestyle intervention for individuals newly diagnosed with CIS or RRMS, who voluntarily decline DMTs, did not yield patient-reported outcomes worse than those observed in the SOC group regarding perceived mental quality of life, mood, fatigue, and cognitive function. Trial Registration: clinicaltrials.gov identifier: NCT04009005.

Association of serum homocysteine, folate, and vitamin B12 and mood following the Swank and Wahls elimination dietary interventions in relapsing-remitting multiple sclerosis: Secondary analysis of the WAVES trial.

BACKGROUND: Depression and anxiety are common psychiatric comorbidities among people with multiple sclerosis (MS). Emerging data suggest abnormal serum homocysteine, vitamin B12, and folate levels in people with MS, which are related to a range of neurological disorders, including mood and mental illnesses. Evidence suggests that dietary interventions could affect mood disorders via several pathways. This study aimed to evaluate the impact of the low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets, along with a supplement regimen, on mood as assessed by Hospital Anxiety and Depression Scale (HADS), and Mental Health Inventory (MHI). The secondary objective was to identify changes in serum levels of homocysteine, folate, and vitamin B12 and the association and mediation effects between their changes and HADS and MHI scores and their subscales among people with relapsing-remitting MS (RRMS). METHODS: In a previously conducted randomized parallel-arm trial, participants with RRMS (n = 77) were randomly allocated to either the Swank or Wahls diets at baseline and followed for 24 weeks. Blood was drawn at four study visits spaced 12 weeks apart: (1) run-in, (2) baseline, (3) 12 weeks, and (4) 24 weeks. Serum vitamin B12, folate, and homocysteine were analyzed. HADS and MHI questionnaires were also completed by participants at the four study visits to assess symptoms of depression and anxiety, behavioral control and positive affect respectively. RESULTS: Significant improvement in severity of depression (HADS-D) and anxiety (HADS-A) symptoms, MHI total, and MHI subscores were seen at 12 and 24 weeks in each diet group. Further, a significant within-group reduction in serum homocysteine and a significant increase in serum vitamin B12 level were observed in both groups at 12 and 24 weeks compared to corresponding baseline values (p ≤ 0.05 for all). All participants exceeded the analytical maximum threshold for folate of 20 nmol/L at 12 and 24 weeks. Changes in serum levels of homocysteine and vitamin B12 were not associated with and did not mediate changes in HADS depression, anxiety, MHI total and four subscales scores (p > 0.05). CONCLUSION: Participants on both Swank and Wahls dietary interventions, including folate and vitamin B12 supplements, showed significant improvement in mood. However, the favorable effects of both diets on mood were not associated with or mediated by the effect of the diets on serum levels of homocysteine, folate, and vitamin B12 (p > 0.05).

Diet-induced changes in functional disability are mediated by fatigue in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES randomized parallel-arm trial.

Background: People with multiple sclerosis (MS) often report dietary modifications; however, evidence on functional outcomes remains sparse. Objective: Evaluate the impact of the low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets on functional disability among people with relapsing-remitting MS. Methods: Baseline-referenced MS functional composite (MSFC) scores were calculated from nine-hole peg-test (NHPT), timed 25-foot walk, and oral symbol digit modalities test (SDMT-O) collected at four study visits: (a) run-in, (b) baseline, (c) 12 weeks, and (d) 24 weeks. Participants were observed at run-in and then randomized at baseline to either the Swank (n = 44) or Wahls (n = 43) diets. Results: Among the Swank group, MSFC scores significantly increased from -0.13 ± 0.14 at baseline to 0.10 ± 0.11 at 12 weeks (p = 0.04) and 0.14 ± 0.11 at 24 weeks (p = 0.02). Among the Wahls group, no change in MSFC scores was observed at 12 weeks from 0.10 ± 0.11 at baseline but increased to 0.28 ± 0.13 at 24 weeks (p = 0.002). In both groups, NHPT and SDMT-O z-scores increased at 24 weeks. Changes in MSFC and NHPT were mediated by fatigue. Discussion: Both diets reduced functional disability as mediated by fatigue. Trial Registration: Clinicaltrials.gov Identifier: NCT02914964.

Association between improved metabolic risk factors and perceived fatigue during dietary intervention trial in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES trial.

Background: Preliminary dietary intervention trials with the low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets have shown favorable effects on fatigue among people with multiple sclerosis (MS); however, their impact on metabolic health is unknown. Objective: To evaluate the impact of the Swank and Wahls diets on markers of metabolic health and to determine the association and mediation effect between changes in metabolic health and perceived fatigue among people with relapsing-remitting MS (RRMS). Methods: As part of a randomized parallel-arm trial, vital signs, blood metabolic biomarkers, and the fatigue scale for motor and cognitive functions (FSMC) were collected from participants with relapsing-remitting MS (n = 77) at four study visits spaced 12 weeks apart: (1) run-in, (2) baseline, (3) 12-weeks, and (4) 24-weeks. Participants followed their usual diet at run-in, then were randomized at baseline to either the Swank or Wahls diets and followed for 24 weeks. Results: Both groups had significant reductions in weight, body mass index (BMI), total cholesterol, and low-density lipoprotein (LDL) at 12- and 24-weeks compared to respective baseline values (p ≤ 0.04 for all). The Swank group also had a significant reduction in high-density lipoprotein (HDL) at 12- and 24-weeks (p = 0.0001 and p = 0.02, respectively), while the Wahls group had significant reductions in diastolic blood pressure (DBP). In addition, both groups had significant reductions in FSMC total perceived fatigue and the motor and cognitive fatigue subscales at 12- and 24-weeks (p ≤ 0.01 for all); however, change in the cognitive subscale was not significant at 12-weeks in the Swank group (p = 0.06). Furthermore, the favorable effects, of both diets, on markers of metabolic health were not associated with and did not mediate the effect of the diets on perceived fatigue (p > 0.05 for all). Conclusion: Both diets lead to significant reductions in perceived fatigue, weight, BMI, total cholesterol, and LDL, but the significant reductions in perceived fatigue were independent of changes in markers of metabolic health.

Change in Micronutrient Intake among People with Relapsing-Remitting Multiple Sclerosis Adapting the Swank and Wahls Diets: An Analysis of Weighed Food Records.

The low-saturated fat (Swank) and modified Paleolithic elimination (Wahls) diets have shown promise for MS symptoms; however, due to their restriction of specific foods, inadequate intake of micronutrients is concerning. Therefore, as part of a randomized trial, weighed food records were collected on three consecutive days and were used to evaluate the intake of micronutrients among people with relapsing remitting MS adapting these diets. After randomization to either the Swank or Wahls diets, diet education and support was provided by registered dietitians at baseline and throughout the first 12 weeks of the intervention. Usual intake of each micronutrient was estimated and then evaluated with the EAR-cut point method. At 12 weeks, the Swank group had significant reductions in the proportion with inadequate intake from food for vitamins C, D, and E, while the Wahls group had significant reductions for magnesium and vitamins A, C, D, and E. However, the proportion with inadequate intake significantly increased for calcium, thiamin, and vitamin B12 in the Wahls group and for vitamin A in the Swank group. Inclusion of intake from supplements reduced the proportion with inadequate intake for all micronutrients except calcium among the Wahls group but increased the proportion with excessive intake for vitamin D and niacin among both groups and magnesium among the Swank group. Both diets, especially when including intake from supplements, are associated with reduced inadequate intake compared to the normal diet of people with relapsing remitting MS.

Redesigned Care Delivery for Insulin-Requiring Diabetes in Pregnancy Improves Perinatal Glycemic Control While Reducing Neonatal Intensive Care Admissions, Length of Stay, and Costs.

Objective: We sought to improve perinatal glycemic control and downstream neonatal outcomes through redesigned ambulatory management for women with insulin-requiring diabetes in pregnancy. Methods: To address gaps in perinatal glycemic management of women with insulin-requiring diabetes in pregnancy, redesigned care delivery (RCD) utilized integrated practice unit and minimally disruptive medicine concepts with incorporation of cellular-enabled glucose monitoring. Primary outcomes of RCD (N = 129) included hemoglobin A1c ([HbA1c], within RCD cohort), and gestational age (GA) at delivery, neonatal intensive care (NICU) admission, and NICU length of stay (LOS) compared with a preredesign care cohort (Pre-RCD; N = 122). Secondary outcomes included facility, payer reimbursement, and program costs. Generalized linear models assessed continuous variables while logistic regression methods assessed categorical outcomes. Results: Utilizing RCD, 92% of women with an initial HbA1c <6.5% maintained glycemic control until delivery, and 67.2% with an initial HbA1c ≥6.5% achieved delivery levels <6.5%. NICU admissions and GA-adjusted LOS decreased significantly [Pre-RCD vs. RCD: NICU admissions, 41.0% vs. 27.3%, p < 0.024; NICU LOS (95% confidence interval [CI]), 21.9 (17.1-26.6) vs. 14.6 (9.1-20.1), p = 0.045]. Every 10 days of redesigned management decreased mean NICU LOS by 1 day. Mean payer neonatal reimbursements decreased over $18,000 per delivery (p = 0.08) compared with implementation costs of $1,942 per delivery. Conclusion: Redesigned perinatal diabetes care with remote glucose monitoring demonstrated improved outcomes and value through downstream neonatal outcomes and lower payer costs. Therefore, subsequent dissemination and sustainability of similar programs' improved outcomes will likely require payer support.

Impact of the Swank and Wahls elimination dietary interventions on fatigue and quality of life in relapsing-remitting multiple sclerosis: The WAVES randomized parallel-arm clinical trial.

OBJECTIVE: To compare the effect of the modified Paleolithic elimination (Wahls) and low-saturated fat (Swank) diets in relapsing-remitting MS (RRMS). METHODS: Individuals (n = 87) with RRMS were randomized to the Swank or Wahls diets in a parallel group clinical trial consisting of four timepoints: 1) run-in, 2) baseline, 3) 12-weeks, and 4) 24-weeks. RESULTS: 77 participants completed 12 weeks and 72 completed 24 weeks. The 12-week change from baseline in fatigue was -0.94 ± 0.18 (FSS) and -9.87 ± 1.93 (MFIS; both p < 0.0001) for Swank, and -0.71 ± 0.24 (FSS; p = 0.004) and -14.41 ± 2.22 (MFIS; p ≤ 0.0001) for Wahls. Physical MSQoL scores improved by 6.04 ± 2.18 (p = 0.006) for Swank and by 14.5 ± 2.63 (p < 0.0001) for Wahls. Mental MSQoL scores improved by 11.3 ± at 2.79 (p < 0.0001) for Wahls while the Swank did not change (3.85 ± 2.63; p = 0.14). Neither group showed significant changes in 6-minute walking distance at 12 weeks. All outcomes were maintained or further improved at 24 weeks. CONCLUSIONS: Both diets were associated with clinically meaningful within-group reductions in fatigue and improvements in QoL.Trial Registration: Clinicaltrials.gov Identifier: NCT02914964.

Risk factors and survival by HPV-16 E6 and E7 antibody status in human papillomavirus positive head and neck cancer.

High-risk human papillomavirus types (HPV-HR) are associated with head and neck cancer (HNC) risk and better survival. Most patients with HPV-HR DNA-positive tumors develop anti-HPV E6/E7 antibodies; however, it is unclear whether those who mount an immune response have similar risk factors or clinical outcomes as those who do not. HPV-16 DNA tumor-positive HNC cases were evaluated for HPV-16 E6 and E7 antibodies using a GST capture ELISA system. Among 57 HPV-16 DNA tumor-positive HNC cases, 67% were detected with HPV-16 E6 and/or E7 antibodies. Male gender (76% vs. 42%, p = 0.02), younger age (63% vs. 16%, p = 0.001) but not tobacco or alcohol were associated with E6 and/or E7 seropositivity. Seropositivity was associated more often with late stage (76%), poor grade (65%), positive nodes (82%). and in the oropharynx (82%), Median disease-specific and recurrence-free survival were longer in E6 and/or E7 seropositive compared to E6/E7-negative cases (2.2 years vs. 1.4 years, both outcomes), although results were not statistically significant. When examined jointly with p16 expression, E6 and/or E7-positive/p16-positive cases had better disease-specific (2.1 years vs. 1.1 years, p = 0.06) and recurrence-free (2.3 years vs. 1.1 years, p = 0.03) survival compared to E6-/E7-/p16- cases. These findings suggest there are 2 distinct HNC patient groups with HPV DNA-positive tumors, distinguishable by E6 and/or E7 antibody status. Differences in antibody status are associated with distinct risk factors and clinical outcomes. This information can be available as a simple blood test at initial presentation, before the removal of tissue through biopsy or surgery.