A Randomized, Placebo-Controlled Clinical Trial of a Novel Dietary Supplement on Standardized CNS Vital Signs Cognitive Performance Parameters in Adults.

Objective: To test the effectiveness of a novel dietary supplement as a support for cognitive function in healthy younger and older adults Design: A double-blind, randomized, placebo-controlled trial of the dietary supplement, Braini® in two age cohorts with 60 participants: 31 healthy younger adults (18-30 years) and 29 healthy older adults (55-80 years). Intervention: A 28-day intervention of a dietary supplement (active or placebo) taken daily with cognitive assessment using CNS Vital Signs computer-based testing at day 0 and 28. Participants were asked to fill out a daily survey regarding compliance with supplement protocol, changes in health, adherence to the protocol, and reported side effects. CNS Vital Signs provides aged normed aggregated outcome measures for Processing Speed, Psychomotor Speed, Reaction Time, Cognitive Flexibility, Executive Function, and Motor Speed. Results: Significant improvements in performance were found for two CNS Vital Signs domains, Cognitive Flexibility (p = 0.048), and Executive Function (p = 0.025) in the treated younger adults (n = 12) compared with the placebo group (n = 19) at day 28 compared with baseline. The Shifting Attention Test Reaction Time (SAT-RT), a measure of shifting attention correct response reaction time, showed significant improvement at 28 days in those taking Braini in both younger (p = 0.004) and older adult cohorts (p = 0.05) with an average improvement over the control subjects of 44%. No serious side effects were reported. Conclusions: The dietary formulation, Braini, safely and significantly improved cognitive flexibility and executive function in younger adults and trended positively in older adults in this study that was stopped prematurely due to pandemic restrictions. Scores on SAT-RT significantly improved in both younger and older adults. Further studies are needed to confirm that Braini reliably improves cognitive function in additional CNS domains in healthy adults. Clinical Trial Registration: Clinicaltrials.gov under registration number: NCT04025255.

Reach and Impact of In-Person and Remote Delivery Formats of Walk with Ease.

This descriptive study retrospectively evaluates the reach and impact of cohorts enrolled in Group (in-person, 2017-2020) and Self-Directed (remote, 2019-2020) delivery formats of the evidenced-based health promotion program, Walk with Ease, implemented statewide in North Carolina. An existing dataset consisting of pre- and post-surveys were analyzed for 1,890 participants; 454 (24%) from the Group format and 1,436 (76%) from Self-Directed. Self-Directed participants were younger, had more years of education, represented more Black/African American and multi-racial participants, and participated in more locations than Group, though a higher percentage of Group participants were from rural counties. Self-Directed participants were less likely to report having arthritis, cancer, chronic pain, diabetes, heart disease, high cholesterol, hypertension, kidney disease, stroke, or osteoporosis, though more likely to report being obese or having anxiety or depression. All participants walked more and expressed higher confidence in managing joint pain following the program. These results promote opportunities for enhancing engagement in Walk with Ease with diverse populations.

Rural-urban outcome differences associated with COVID-19 hospitalizations in North Carolina.

People living in rural regions in the United States face more health challenges than their non-rural counterparts which could put them at additional risks during the COVID-19 pandemic. Few studies have examined if rurality is associated with additional mortality risk among those hospitalized for COVID-19. We studied a retrospective cohort of 3,991 people hospitalized with SARS-CoV-2 infections discharged between March 1 and September 30, 2020 in one of 17 hospitals in North Carolina that collaborate as a clinical data research network. Patient demographics, comorbidities, symptoms and laboratory data were examined. Logistic regression was used to evaluate associations of rurality with a composite outcome of death/hospice discharge. Comorbidities were more common in the rural patient population as were the number of comorbidities per patient. Overall, 505 patients died prior to discharge and 63 patients were discharged to hospice. Among rural patients, 16.5% died or were discharged to hospice vs. 13.3% in the urban cohort resulting in greater odds of death/hospice discharge (OR 1.3, 95% CI 1.1, 1.6). This estimate decreased minimally when adjusted for age, sex, race/ethnicity, payer, disease comorbidities, presenting oxygen levels and cytokine levels (adjusted model OR 1.2, 95% CI 1.0, 1.5). This analysis demonstrated a higher COVID-19 mortality risk among rural residents of NC. Implementing policy changes may mitigate such disparities going forward.

A Statewide Approach to Falls Prevention: Widespread Implementation of A Matter of Balance in North Carolina, 2014-2019.

This study showcases the statewide strategies used to implement and sustain an evidence-based fall prevention program, A Matter of Balance (MOB) in North Carolina between 2014 and 2019. Statewide program implementation and data collection support strategies are detailed. The mostly White (not Hispanic/Latino), female participants were 75 years old on average. Pre- and post-self-reported assessments included demographic, health status, quality of life, and falls-related metrics. Survey responses were scaled and analyzed. Statistically significant improvements (p < .05) across health status measurements, times fallen, and falls resulting in injury were observed. These results offer a model for effective statewide implementation of the MOB program to reduce falls among older adults in community settings with support from a statewide resource center.

Reduced cancer risk in vegetarians: an analysis of recent reports.

This report reviews current evidence regarding the relationship between vegetarian eating patterns and cancer risk. Although plant-based diets including vegetarian and vegan diets are generally considered to be cancer protective, very few studies have directly addressed this question. Most large prospective observational studies show that vegetarian diets are at least modestly cancer protective (10%-12% reduction in overall cancer risk) although results for specific cancers are less clear. No long-term randomized clinical trials have been conducted to address this relationship. However, a broad body of evidence links specific plant foods such as fruits and vegetables, plant constituents such as fiber, antioxidants and other phytochemicals, and achieving and maintaining a healthy weight to reduced risk of cancer diagnosis and recurrence. Also, research links the consumption of meat, especially red and processed meats, to increased risk of several types of cancer. Vegetarian and vegan diets increase beneficial plant foods and plant constituents, eliminate the intake of red and processed meat, and aid in achieving and maintaining a healthy weight. The direct and indirect evidence taken together suggests that vegetarian diets are a useful strategy for reducing risk of cancer.

Food, plant food, and vegetarian diets in the US dietary guidelines: conclusions of an expert panel.

We summarize conclusions drawn from a panel discussion at the "Fifth International Congress on Vegetarian Nutrition" about the roles of and emphasis on food, plant food, and vegetarianism in current and future US dietary guidelines. The most general recommendation of the panel was that future dietary guidelines, following the lead of the 2005 Dietary Guidelines Advisory Committee, should emphasize food-based recommendations and thinking to the full extent that evidence allows. Although nutrient-based thinking and Dietary Reference Intakes (DRIs) may help ensure an adequate diet in the sense that deficiency states are avoided, the emphasis on DRIs may not capture many important nutritional issues and may inhibit a focus on foods. More generally, in the context of the conference on vegetarian nutrition, this report focuses on the history and structure of the Dietary Guidelines Advisory Committee, on various plant food-oriented recommendations that are supported by literature evidence, and on mechanisms for participating in the process of forming dietary guidelines. Among recommendations that likely would improve health and the environment, some are oriented toward increased plant food consumption and some toward vegetarianism. The literature on health effects of individual foods and whole lifestyle diets is insufficient and justifies a call for future food-oriented research, including expanding the evidence base for plant-based and vegetarian diets. The Dietary Guidelines Advisory Committee's role should be carried forward to creation of a publicly accessible icon (eg, the current pyramid) and related materials to ensure that the science base is fully translated for the public.

Should dairy be recommended as part of a healthy vegetarian diet? Counterpoint.

Although cow milk has been widely recommended in Western countries as necessary for growth and bone health, evidence collected during the past 20 y shows the need to rethink strategies for building and maintaining strong bones. Osteoporotic bone fracture rates are highest in countries that consume the most dairy, calcium, and animal protein. Most studies of fracture risk provide little or no evidence that milk or other dairy products benefit bone. Accumulating evidence shows that consuming milk or dairy products may contribute to the risk of prostate and ovarian cancers, autoimmune diseases, and some childhood ailments. Because milk is not necessary for humans after weaning and the nutrients it contains are readily available in foods without animal protein, saturated fat, and cholesterol, vegetarians may have healthier outcomes for chronic disease if they limit or avoid milk and other dairy products. Bones are better served by attending to calcium balance and focusing efforts on increasing fruit and vegetable intakes, limiting animal protein, exercising regularly, getting adequate sunshine or supplemental vitamin D, and getting approximately 500 mg Ca/d from plant sources. Therefore, dairy products should not be recommended in a healthy vegetarian diet.

Dairy and weight loss hypothesis: an evaluation of the clinical trials.

This review evaluates evidence from clinical trials that assessed the effect of dairy product or calcium intake, with or without concomitant energy restriction, on body weight and adiposity. Of 49 randomized trials assessing the effect of dairy products or calcium supplementation on body weight, 41 showed no effect, two demonstrated weight gain, one showed a lower rate of gain, and five showed weight loss. Four of 24 trials report differential fat loss. Consequently, the majority of the current evidence from clinical trials does not support the hypothesis that calcium or dairy consumption aids in weight or fat loss.

Relation of omega-3 Fatty Acid intake to other dietary factors known to reduce coronary heart disease risk.

Data supporting the inverse correlation of fish or long-chain omega-3 fatty acid (FA) (eicosapentaenoic acid plus docosahexaenoic acid) supplement consumption and coronary heart disease are inconclusive and may be confounded by other dietary and lifestyle factors. Using the Diabetic Control and Complications Trial (DCCT) database (n = 1,441), correlations between consumption of omega-3 FAs and saturated FAs to dietary variables (kilocalories, macronutrients, sodium, and cholesterol) and to age, gender, exercise level, and tobacco use were tested using Pearson correlation coefficients. Long-chain omega-3 FA intake inversely correlated with consumption of calories (r = -0.16, p <0.0001), percent calories from total fat (r = -0.14, p <0.0001), and percent calories from saturated FAs (r = -0.21, p <0.0001) and directly with dietary fiber intake (grams per 1,000 kcal, r = 0.20, p <0.0001). In the DCCT database, long-chain omega-3 FAs (i.e., fish consumption) inversely correlated with an overall low risk nutritional profile for coronary heart disease. In conclusion, these findings provide evidence that associations observed in studies suggesting a benefit of fish or long-chain omega-3 FAs may be due to a convergence of greater fish intakes with an overall healthier dietary pattern rather than with a specific effect of long-chain omega-3 FAs.

Calcium, dairy products, and bone health in children and young adults: a reevaluation of the evidence.

OBJECTIVE: Numerous nutrition policy statements recommend the consumption of 800 to 1500 mg of calcium largely from dairy products for osteoporosis prevention; however, the findings of epidemiologic and prospective studies have raised questions about the efficacy of the use of dairy products for the promotion of bone health. The objective of this study was to review existing literature on the effects of dairy products and total dietary calcium on bone integrity in children and young adults to assess whether evidence supports (1) current recommended calcium intake levels and (2) the suggestion that dairy products are better for promoting bone integrity than other calcium-containing food sources or supplements. METHODS: A Medline (National Library of Medicine, Bethesda, MD) search was conducted for studies published on the relationship between milk, dairy products, or calcium intake and bone mineralization or fracture risk in children and young adults (1-25 years). This search yielded 58 studies: 22 cross-sectional studies; 13 retrospective studies; 10 longitudinal prospective studies; and 13 randomized, controlled trials. RESULTS: Eleven of the studies did not control for weight, pubertal status, and exercise and were excluded. Ten studies were randomized, controlled trials of supplemental calcium, 9 of which showed modest positive benefits on bone mineralization in children and adolescents. Of the remaining 37 studies of dairy or unsupplemented dietary calcium intake, 27 studies found no relationship between dairy or dietary calcium intake and measures of bone health. In the remaining 9 reports, the effects on bone health are small and 3 were confounded by vitamin D intake from milk fortified with vitamin D. Therefore, in clinical, longitudinal, retrospective, and cross-sectional studies, neither increased consumption of dairy products, specifically, nor total dietary calcium consumption has shown even a modestly consistent benefit for child or young adult bone health. CONCLUSION: Scant evidence supports nutrition guidelines focused specifically on increasing milk or other dairy product intake for promoting child and adolescent bone mineralization.