Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes.

PURPOSE: Improved management of pain and co-morbid symptoms (sleep disturbances, psychological distress) among women undergoing surgery for suspected gynecologic malignancies may reach a population vulnerable to chronic pain. PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHOD: We conducted a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). Semi-structured interviews were conducted by telephone (n = 23), recorded, transcribed, coded, and analyzed using thematic analysis. FINDINGS: Participants reported overall high acceptability such that all would recommend the study to others. Positive impacts of practicing eMMB included that it relieved tension, facilitated falling asleep, and decreased pain. Participants also reported high adherence to self-directed eMMB and AC writing practices and described facilitators and barriers to practicing. CONCLUSIONS: This qualitative feedback will inform future research to assess the efficacy of eMMB for reducing pain and use of remotely-delivered interventions more broadly. CLINICAL TRIAL REGISTRATION NUMBER: NCT03681405.

Major Gaps in Understanding Dietary Supplement Use in Health and Disease.

Precise dietary assessment is critical for accurate exposure classification in nutritional research, typically aimed at understanding how diet relates to health. Dietary supplement (DS) use is widespread and represents a considerable source of nutrients. However, few studies have compared the best methods to measure DSs. Our literature review on the relative validity and reproducibility of DS instruments in the United States [e.g., product inventories, questionnaires, and 24-h dietary recalls (24HR)] identified five studies that examined validity (n = 5) and/or reproducibility (n = 4). No gold standard reference method exists for validating DS use; thus, each study's investigators chose the reference instrument used to measure validity. Self-administered questionnaires agreed well with 24HR and inventory methods when comparing the prevalence of commonly used DSs. The inventory method captured nutrient amounts more accurately than the other methods. Reproducibility (over 3 months to 2.4 years) of prevalence of use estimates on the questionnaires was acceptable for common DSs. Given the limited body of research on measurement error in DS assessment, only tentative conclusions on these DS instruments can be drawn at present. Further research is critical to advancing knowledge in DS assessment for research and monitoring purposes.

Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial.

BACKGROUND: Low 25-hydroxyvitamin D (25[OH]D) concentrations (<30 ng/mL [<50 nmol/L]) have been associated with muscle weakness and impaired physical performance in observational studies. However, the effect of vitamin D supplementation on changes in muscle strength and physical performance in randomized controlled trials has been mixed. OBJECTIVES: To determine the effect of daily vitamin D supplementation on leg power, strength, and physical performance in low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL. METHODS: In this double-blind, randomized controlled trial, 136 low-functioning [Short Physical Performance Battery (SPPB) scores ≤10] adults aged 65-89 y with 25(OH)D concentrations of 18 to <30 ng/mL were randomly assigned to 2000 IU/d vitamin D3 or placebo for 12 mo. Lower-extremity leg power (primary outcome), leg and grip strength, SPPB, timed up and go (TUG), postural sway, and gait velocity and spatiotemporal parameters (secondary outcomes) were assessed at baseline, 4 and 12 mo. A subset (n = 37) also underwent a muscle biopsy at baseline and 4 mo and muscle fiber composition and contractile properties were assessed. RESULTS: Participants' mean ± SD age and SPPB scores at baseline were 73.4 ± 6.3 y and 7.8 ± 1.8, respectively. Mean ± SD 25(OH)D concentrations at baseline and 12 mo were 19.4 ± 4.2 ng/mL and 28.6 ± 6.7 ng/mL in the vitamin D group and 19.9 ± 4.9 ng/mL and 20.2 ± 5.0 ng/mL in the placebo group for a mean ± SE difference of 9.1 ± 1.1 ng/mL (P < 0.0001). However, there were no differences in change in leg power, leg or grip strength, SPPB score, TUG, postural sway, or gait velocity and spatiotemporal parameters by intervention group over 12 mo or muscle fiber composition and contractile properties over 4 mo. CONCLUSIONS: In low-functioning older adults with 25(OH)D concentrations of 18 to <30 ng/mL, randomization to 2000 IU/d vitamin D3 did not result in improvements in leg power, strength, or physical performance or muscle fiber composition and contractile properties. This trial was registered at clinicaltrials.gov as NCT02015611.

Study design and methods for the pilot study of muscadine grape extract supplement to improve fatigue among older adult cancer survivors (FOCUS) trial.

INTRODUCTION: Fatigue is a prevalent symptom among both cancer survivors and older adults. Negative consequences of fatigue include increased sedentary behavior, decreased physical activity and function, and lower quality of life. Few pharmacologic interventions improve fatigue. Our preclinical and clinical data show promising effects of a muscadine grape extract supplement (MGES) on oxidative stress, mitochondrial bioenergetics, the microbiome, and the symptom of fatigue. This pilot study seeks to translate these observations to cancer survivorship by testing the preliminary effect of MGE supplementation on older adult cancer survivors with self-reported fatigue. MATERIALS AND METHODS: We designed a double-blinded placebo-controlled pilot study to evaluate preliminary efficacy of MGE supplementation versus placebo on fatigue among older adult cancer survivors (aged ≥65 years) who report baseline fatigue. Sixty-four participants will be enrolled and randomized 1:1 to twice daily MGES (four tablets twice daily) versus placebo for 12 weeks. The primary outcome is change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue score from baseline to 12 weeks. Secondary outcomes are change in self-reported physical function, physical fitness (6-min walk test), self-reported physical activity, global quality of life (QOL), and the Fried frailty index. Correlative biomarker assays will assess changes in 8-hydroxy-2 deoxyguanosine, peripheral blood mitochondrial function, inflammatory markers, and the gut microbiome. DISCUSSION: This pilot study builds on preclinical and clinical observations to estimate effects of MGE supplementation on fatigue, physical function, QOL, and biologic correlates in older adult cancer survivors. Trial registration #: CT.govNCT04495751; IND 152908.

Qualitative similarities and distinctions between participants' experiences with a yoga intervention and an attention control.

PURPOSE: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer. METHODS: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory. RESULTS: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST. CONCLUSIONS: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious.

Factors associated with falls in older adults: A secondary analysis of a 12-month randomized controlled trial.

PURPOSE: While identifying older adults at risk for falls is important, fall prediction models have had limited success, in part because of a poor understanding of which physical function measures to include. The purpose of this secondary analysis was to determine physical function measures that are associated with future falls in older adults. METHODS: In a 12-month trial comparing Vitamin D3 supplementation versus placebo on neuromuscular function, 124 older adults completed physical function measures at baseline, including the Short Physical Performance Battery (SPPB), Timed Up and Go, tests of leg strength and power, standing balance on a force plate with firm and foam surfaces, and walking over an instrumented walkway. Falls were recorded with monthly diaries over 12 months and categorized as no falls vs. one or more falls. Univariate and multivariable logistic regression adjusting for demographics, treatment assignment, depression, and prescription medications were conducted to examine the association between each physical function measure and future falls. Models were additionally adjusted for fall history. RESULTS: 61 participants sustained one or more falls. In univariate analysis, white race, depression, fall history, SPPB, and postural stability on foam were significantly associated with future falls. In multivariable analysis, fall history (OR (95% CI): 3.20 (1.42-7.43)), SPPB (0.80 (0.62-1.01)), and postural stability on foam (3.01 (1.18, 8.45)) were each significantly associated with future falls. After adjusting for fall history, only postural stability on foam was significantly associated with falls. CONCLUSIONS: When developing fall prediction models, fall history, the SPPB, and postural stability when standing on foam should be considered.

A randomized pilot of eHealth mindful movement and breathing to improve gynecologic surgery outcomes.

OBJECTIVE: To conduct a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHODS: eMMB is a brief yoga intervention delivered remotely during the perioperative timeframe. We assessed feasibility and participants completed assessments (baseline, weeks 2 and 4 postoperatively). We summarized feasibility, participant characteristics, and outcomes by intervention group and time. FINDINGS: Forty-three percent of eligible patients approached participated (n = 31). Adherence to the interventions was 77%. Percent of participants to complete outcomes was 81% at Week 2 and 84% at Week 4 (>70%; retention was the primary feasibility indicator). Average reductions in the primary outcome of pain intensity were larger in the eMMB group than AC group (Week 2 d = -0.38; Week 4 d = -0.46). IMPLICATIONS: This pilot study of eMMB supported feasibility and improvements in pain intensity that warrant a future efficacy study.

Trends in Overall and Micronutrient-Containing Dietary Supplement Use in US Adults and Children, NHANES 2007-2018.

BACKGROUND: Dietary supplement (DS) use is widespread in the United States and contributes large amounts of micronutrients to users. Most studies have relied on data from 1 assessment method to characterize the prevalence of DS use. Combining multiple methods enhances the ability to capture nutrient exposures from DSs and examine trends over time. OBJECTIVES: The objective of this study was to characterize DS use and examine trends in any DS as well as micronutrient-containing (MN) DS use in a nationally representative sample of the US population (≥1 y) from the 2007-2018 NHANES using a combined approach. METHODS: NHANES obtains an in-home inventory with a frequency-based dietary supplement and prescription medicine questionnaire (DSMQ), and two 24-h dietary recalls (24HRs). Trends in the prevalence of use and selected types of products used were estimated for the population and by sex, age, race/Hispanic origin, family income [poverty-to-income ratio (PIR)], and household food security (food-secure vs. food-insecure) using the DSMQ or ≥ 1 24HR. Linear trends were tested using orthogonal polynomials (significance set at P < 0.05). RESULTS: DS use increased from 50% in 2007 to 56% in 2018 (P = 0.001); use of MN products increased from 46% to 49% (P = 0.03), and single-nutrient DS (e.g., magnesium, vitamins B-12 and D) use also increased (all P < 0.001). In contrast, multivitamin-mineral use decreased (70% to 56%; P < 0.001). In adults (≥19 y), any (54% to 61%) and MN (49% to 54%) DS use increased, especially in men, non-Hispanic blacks and Hispanics, and low-income adults (PIR ≤130%). In children (1-18 y), any DS use remained stable (∼38%), as did MN use, except for food-insecure children, whose use increased from 24% to 31% over the decade (P = 0.03). CONCLUSIONS: The prevalence of any and MN DS use increased over time in the United States. This may be partially attributed to increased use of single-nutrient products. Population subgroups differed in their DS use.

A Randomized Intervention of Supplemental Nutrition Assistance Program-Education Did Not Improve Dietary Outcomes Except for Vitamin D Among Lower-Income Women in Indiana.

BACKGROUND: The goal of US Department of Agriculture Supplemental Nutrition Assistance Program-Education (SNAP-Ed) is to improve the likelihood that those eligible for SNAP will make healthy choices aligned with the Dietary Guidelines for Americans, 2020-2025. OBJECTIVE: The objective of the study was to evaluate the long-term effects of a direct SNAP-Ed intervention in which participants actively engage in learning with educator instruction about dietary quality and usual intake of key nutrient and food groups among Indiana SNAP-Ed-eligible women participants as an example sample in the context of no similar existing evaluation. DESIGN: The study design was a parallel-arm, randomized controlled, nutrition education intervention, with follow-up at 1 year. PARTICIPANTS/SETTING: Participants (18 years and older; n = 97 women) eligible for SNAP-Ed and interested in receiving nutrition education lessons were recruited from 31 Indiana counties from August 2015 to May 2016 and randomized to an intervention (n = 53) or control (n = 44) group. INTERVENTION: The intervention comprised core lessons of Indiana SNAP-Ed delivered between 4 and 10 weeks after baseline assessment. Each participant completed a baseline and 1-year follow-up assessment. Dietary intake was assessed using repeated 24-hour dietary recalls (up to 2). MAIN OUTCOME MEASURES: Mean usual nutrient, food group intake, diet quality (ie, Healthy Eating Index-2010 scores), and proportion of intervention and control groups meeting Dietary Guidelines for Americans, 2020-2025 recommendations and Dietary Reference Intake indicators of requirement or adequacy, were determined using the National Cancer Institute method and the simple Healthy Eating Index-2010 scoring algorithm method. Dietary changes between intervention and control groups were examined over time using mixed linear models. STATISTICAL ANALYSES PERFORMED: Bonferroni-corrected significance levels were applied to the results of the mixed linear models for comparisons of usual intake of nutrients and foods. RESULTS: No differences in diet quality, intake of food group components, food group intake, or nutrients were observed at 1-year follow-up, except that vitamin D intake was higher among those who received SNAP-Ed compared with the control group. CONCLUSIONS: A direct SNAP-Ed intervention did not improve diet quality, food group intake, or key nutrient intake, except for vitamin D, among Indiana SNAP-Ed-eligible women up to 1 year after the nutrition education.

A narrative review of nutrient based indexes to assess diet quality and the proposed total nutrient index that reflects total dietary exposures.

A priori dietary indices provide a standardized, reproducible way to evaluate adherence to dietary recommendations across different populations. Existing nutrient-based indices were developed to reflect food/beverage intake; however, given the high prevalence of dietary supplement (DS) use and its potentially large contribution to nutrient intakes for those that use them, exposure classification without accounting for DS is incomplete. The purpose of this article is to review existing nutrient-based indices and describe the development of the Total Nutrient Index (TNI), an index developed to capture usual intakes from all sources of under-consumed micronutrients among the U.S. population. The TNI assesses U.S. adults' total nutrient intakes relative to recommended nutrient standards for eight under-consumed micronutrients identified by the Dietary Guidelines for Americans: calcium, magnesium, potassium, choline, and vitamins A, C, D, E. The TNI is scored from 0 to 100 (truncated at 100). The mean TNI score of U.S. adults (≥19 y; n = 9,954) based on dietary data from NHANES 2011-2014, was 75.4; the mean score for the index ignoring DS contributions was only 69.0 (t-test; p < 0.001). The TNI extends existing measures of diet quality by including nutrient intakes from all sources and was developed for research, monitoring, and policy purposes.Supplemental data for this article is available online at https://doi.org/10.1080/10408398.2021.1967872.

Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial.

BACKGROUND: Head and neck cancer (HNC) patients undergoing radiation therapy (RT) experience significant side effects, presenting challenging care tasks for their informal (unpaid) caregivers. HNC caregivers report low caregiving self-efficacy, high distress, and interest in supportive care interventions. OBJECTIVE: This randomized pilot trial assessed the feasibility and acceptability of a 6 to 7 week supported self-management intervention (Prepare to Care) offering psychoeducation and stress management skills building for caregivers of patients receiving RT for HNC. METHODS: Caregivers were randomized to Prepare to Care or standard of care. Primary feasibility measures included participation and retention percentages. Assessments were completed before the intervention, at intervention completion, and 6-weeks later after intervention completion. RESULTS: Caregivers (N = 38) were predominantly female (88.6%), an average age of 56 years old, and a spouse/partner to the patient (71.4%). Participation percent was 42.2%; retention at intervention conclusion was 80% and 77% at the 6-week follow-up. Quantitative and qualitative results support acceptability, with 64% to 88% reporting each intervention module was helpful (quite a bit or very). Intervention caregivers reported a significantly greater improvement in self-efficacy for progressive muscle relaxation (PMR). CONCLUSIONS: Prepare to Care and the randomized pilot trial methods are feasible and acceptable for HNC caregivers of patients receiving RT. A significant treatment effect was observed for self-efficacy for PMR, and findings were in the expected direction regarding improved caregiving self-efficacy. Further research is necessary to determine the efficacy of this intervention with a focus on increased engagement strategies and longer-term outcomes. TRIAL REGISTRATION: NCT03032250.

Evaluating a Food Pantry-Based Intervention to Improve Food Security, Dietary Intake, and Quality in Midwestern Food Pantries.

BACKGROUND: Voices for Food was a longitudinal community, food pantry-based intervention informed by the social ecological model, and designed to improve food security, dietary intake, and quality among clients, which was carried out in 24 rural food pantries across 6 Midwestern states. OBJECTIVE: Our objective was to evaluate changes in adult food security, dietary intake, and quality from baseline (2014) to follow-up (2016), and to assess the role of adult food security on dietary outcomes. DESIGN: A multistate, longitudinal, quasi-experimental intervention with matched treatment and comparison design was used to evaluate treatment vs comparison group changes over time and changes in both groups over time. PARTICIPANTS/SETTING: Adult food pantry clients (n = 617) completed a demographic food security survey, and up to three 24-hour dietary recalls at baseline (n = 590) and follow-up (n = 160). INTERVENTION: Community coaching served as the experimental component, which only "treatment" communities received, and a food council guide and food pantry toolkit were provided to both "treatment" and matched "comparison" communities. MAIN OUTCOME MEASURES: Change in adult food security status, mean usual intakes of nutrients and food groups, and Healthy Eating Index-2010 scores were the main outcome measures. STATISTICAL ANALYSES PERFORMED: Linear mixed models estimated changes in outcomes by intervention group and by adult food security status over time. RESULTS: Improvements in adult food security score (-0.7 ± 0.3; P = .01), Healthy Eating Index-2010 total score (4.2 ± 1.1; P < .0001), and empty calories component score (3.4 ± 0.5; P <.0001) from baseline to follow-up were observed in treatment and comparison groups, but no statistically significant changes were found for adult food security status, dietary quality, and usual intakes of nutrients and food groups between the 2 groups over time. The intervention effect on dietary quality and usual intake changes over time by adult food security status were also not observed. CONCLUSIONS: Food pantry clients in treatment and comparison groups had higher food security and dietary quality at the follow-up evaluation of the Voices for Food intervention trial compared with baseline, despite the lack of difference among the groups as a result of the experimental coaching component.

The Total Nutrient Index is a Useful Measure for Assessing Total Micronutrient Exposures Among US Adults.

BACKGROUND: Most dietary indices reflect foods and beverages and do not include exposures from dietary supplements (DS) that provide substantial amounts of micronutrients. A nutrient-based approach that captures total intake inclusive of DS can strengthen exposure assessment. OBJECTIVES: We examined the construct and criterion validity of the Total Nutrient Index (TNI) among US adults (≥19 years; nonpregnant or lactating). METHODS: The TNI includes 8 underconsumed micronutrients identified by the Dietary Guidelines for Americans: calcium; magnesium; potassium; choline; and vitamins A, C, D, and E. The TNI is expressed as a percentage of the RDA or Adequate Intake to compute micronutrient component scores; the mean of the component scores yields the TNI score, ranging from 0-100. Data from exemplary menus and the 2003-2006 (≥19 years; n = 8861) and 2011-2014 NHANES (≥19 years; n = 9954) were employed. Exemplary menus were used to determine whether the TNI yielded high scores from dietary sources (women, 31-50 years; men ≥ 70 years). TNI scores were correlated with Healthy Eating Index (HEI) 2015 overall and component scores for dairy, fruits, and vegetables; TNI component scores for vitamins A, C, D, and E were correlated with respective biomarker data. TNI scores were compared between groups with known differences in nutrient intake based on the literature. RESULTS: The TNI yielded high scores on exemplary menus (84.8-93.3/100) and was moderately correlated (r = 0.48) with the HEI-2015. Mean TNI scores were significantly different for DS users (83.5) compared with nonusers (67.1); nonsmokers (76.8) compared with smokers (70.3); and those living with food security (76.6) compared with food insecurity (69.1). Correlations of TNI vitamin component scores with available biomarkers ranged from 0.12 (α-tocopherol) to 0.36 (serum 25-hydroxyvitamin D), and were significantly higher than correlations obtained from the diet alone. CONCLUSIONS: The evaluation of validity supports that the TNI is a useful construct to assess total micronutrient exposures of underconsumed micronutrients among US adults.

A Randomized Controlled Pilot Study of Yoga Skills Training Versus an Attention Control Delivered During Chemotherapy Administration.

CONTEXT: It is important to address fatigue and co-occurring symptoms during chemotherapy to preserve quality of life in patients with gastrointestinal (GI) cancer. OBJECTIVE: To conduct a randomized controlled pilot study of a Yoga Skills Training (YST) intervention compared to an attention control (AC) among adults diagnosed with GI cancer. METHODS: YST consisted of four 30-minute sessions delivered individually during chemotherapy plus home practice. AC provided empathic attention plus home diaries. Patient-reported (PROMIS T-score) assessments of fatigue, depressive symptoms, sleep disturbances, and psychological stress (Perceived Stress Scale) were collected at chemotherapy visits: baseline, Week 8, Week 10 and Week 14, and analyzed using a mixed effects model. Inflammatory cytokines were assessed at baseline and Week 10. RESULTS: Forty-four of 77 adults approached agreed to participate (57%; YST n = 23; AC n = 21). Participants' mean age was 58 years and 48% were men. Participants randomized to YST reported a larger decline in fatigue (-2.4 difference, d = 0.30) and depressive symptoms (-2.5 difference, d = 0.30) than AC participants from baseline to Week 10 and sleep disturbances at Week 8 (-3.9 difference, d = 0.50). Differences in magnitude of change in symptoms were consistent with or exceeded a minimally important difference. Psychological stress decreased more in the AC at Week 10 (d = 0.30). Reductions in inflammatory cytokines (IL-6, sTNF R1) were larger in the YST group than AC. CONCLUSION: YST showed promise for improving fatigue, depressive symptoms, sleep disturbances, and inflammation. YST is also feasible and reaches patients underrepresented in yoga research (i.e., GI cancer, men), thus warranting further examination.

Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016.

BACKGROUND: Food insecurity is associated with poorer nutrient intakes from food sources and lower dietary supplement use. However, its association with total usual nutrient intakes, inclusive of dietary supplements, and biomarkers of nutritional status among US children remains unknown. OBJECTIVE: The objective was to assess total usual nutrient intakes, Healthy Eating Index-2015 (HEI-2015) scores, and nutritional biomarkers by food security status, sex, and age among US children. METHODS: Cross-sectional data from 9147 children aged 1-18 y from the 2011-2016 NHANES were analyzed. Usual energy and total nutrient intakes and HEI-2015 scores were estimated using the National Cancer Institute method from 24-h dietary recalls. RESULTS: Overall diet quality was poor, and intakes of sodium, added sugars, and saturated fat were higher than recommended limits, regardless of food security status. Food-insecure girls and boys were at higher risk of inadequate intakes for vitamin D and magnesium, and girls also had higher risk for inadequate calcium intakes compared with their food-secure counterparts, when total intakes were examined. Choline intakes of food-insecure children were less likely to meet the adequate intake than those of their food-secure peers. No differences by food security status were noted for folate, vitamin C, iron, zinc, potassium, and sodium intakes. Food-insecure adolescent girls aged 14-18 y were at higher risk of micronutrient inadequacies than any other subgroup, with 92.8% (SE: 3.6%) at risk of inadequate intakes for vitamin D. No differences in biomarkers for vitamin D, folate, iron, and zinc were observed by food security status. The prevalence of iron deficiency was 12.7% in food-secure and 12.0% in food-insecure adolescent girls. CONCLUSIONS: Food insecurity was associated with compromised intake of some micronutrients, especially among adolescent girls. These results highlight a need for targeted interventions to improve children's overall diet quality, including the reduction of specific nutrient inadequacies, especially among food-insecure children. This study was registered at clinicaltrials.gov as NCT03400436.

Phase I Study of Muscadine Grape Extract for Patients With Advanced Cancer.

OBJECTIVE: Preclinical studies with muscadine grape extract (MGE) show antitumor activity and decreased systemic inflammation. This phase I study (NCT02583269) assessed safety and tolerability of a proprietary MGE preparation in patients with advanced solid tumors. METHODS: Patients with metastatic or unresectable cancers who were progressing on standard therapies were assigned to MGE in a standard 3+3 design. Five dose levels were tested (320 to 1600 mg total phenolics/d). Safety and maximum-tolerated dose were assessed after 4 weeks. Patients were evaluated for response at 8 weeks and continued on MGE if clinically stable. Secondary outcomes were response, survival, adherence, fatigue, and quality of life (QOL). RESULTS: In total, 23 patients (lung, n=7; gastrointestinal, n=7; genitourinary, n=6; other, n=3) received MGE capsules by mouth twice daily. The cohort [median age 72 years, 48% Eastern Cooperative Oncology Group (ECOG) 2] was heavily pretreated. After 4 weeks on MGE, possibly attributable adverse events grade 2 or higher were fatigue (n=1), decreased lymphocyte count (n=1), and constipation (n=2), including 1 dose-limiting toxicity for grade 3 constipation. Maximum-tolerated dose was not reached. No partial responses were observed. Median time on therapy was 8 weeks, with 29% of patients treated beyond 16 weeks and a median overall survival of 7.2 months. QOL and fatigue levels were stable from baseline to 8 weeks. Higher MGE dose was correlated with improvement in self-reported physical well-being QOL at 8 weeks (r=0.6; P=0.04). CONCLUSIONS: MGE is safe and well-tolerated in heavily pretreated and older cancer patients.  The potential anticancer properties and the effects of MGE on physical well-being and QOL metrics will be evaluated in future studies.

Dietary Quality and Usual Intake of Underconsumed Nutrients and Related Food Groups Differ by Food Security Status for Rural, Midwestern Food Pantry Clients.

BACKGROUND: Food pantry users represent a predominantly food insecure population, yet dietary intake may differ among food secure (FS), low FS, and very low FS clients. Usual intake of food groups and nutrients by food security status has not previously been compared among food pantry clients. OBJECTIVE: This study aimed to estimate the usual intakes of underconsumed nutrients (ie, potassium; dietary fiber; choline; magnesium; calcium; vitamins A, D, E, and C; and iron) and related food groups (ie, vegetables, fruits, whole grains, and dairy) and dietary quality, and to evaluate their relationship with food security status. DESIGN: This cross-sectional, secondary analysis used baseline data from a prior intervention study (Clinical Trial Registry: NCT03566095). A demographic questionnaire, the US Household Food Security Survey Module, and up to three 24-hour dietary recalls on nonconsecutive days, including weekdays and weekends, were collected. PARTICIPANTS/SETTING: This community-based study included a convenience sample of adult, midwestern food pantry clients (N=579) recruited from August to November 2014. MAIN OUTCOME MEASURES: Main outcomes evaluated were Healthy Eating Index-2010 scores and usual intakes of underconsumed nutrients and related food groups. STATISTICAL ANALYSES PERFORMED: Linear regression models and the National Cancer Institute method, adjusting for confounders, were used to estimate associations of food security with diet quality and usual intake, respectively. RESULTS: Being FS was associated with a higher whole grains HEI-2010 score and higher mean usual intake of whole grains compared with being low FS. Being FS was associated with higher usual intakes of iron and dairy compared with being very low FS. Being FS was associated with a higher mean usual intake of dark green vegetables compared with being low FS and very low FS. Usual intakes were below federal guidance for all subgroups of food security. CONCLUSIONS: Although food security status may differentiate dietary intake among food pantry clients, improvements are needed among all clients.

Older adults with obesity have higher risks of some micronutrient inadequacies and lower overall dietary quality compared to peers with a healthy weight, National Health and Nutrition Examination Surveys (NHANES), 2011-2014.

OBJECTIVE: To evaluate total usual intakes and biomarkers of micronutrients, overall dietary quality and related health characteristics of US older adults who were overweight or obese compared with a healthy weight. DESIGN: Cross-sectional study. SETTING: Two 24-h dietary recalls, nutritional biomarkers and objective and subjective health characteristic data were analysed from the National Health and Nutrition Examination Survey 2011-2014. We used the National Cancer Institute method to estimate distributions of total usual intakes from foods and dietary supplements for eleven micronutrients of potential concern and the Healthy Eating Index (HEI)-2015 score. PARTICIPANTS: Older adults aged ≥60 years (n 2969) were categorised by sex and body weight status, using standard BMI categories. Underweight individuals (n 47) were excluded due to small sample size. RESULTS: A greater percentage of obese older adults compared with their healthy-weight counterparts was at risk of inadequate Mg (both sexes), Ca, vitamin B6 and vitamin D (women only) intakes. The proportion of those with serum 25-hydroxyvitamin D < 40 nmol/l was higher in obese (12 %) than in healthy-weight older women (6 %). Mean overall HEI-2015 scores were 8·6 (men) and 7·1 (women) points lower in obese than in healthy-weight older adults. In addition, compared with healthy-weight counterparts, obese older adults were more likely to self-report fair/poor health, use ≥ 5 medications and have limitations in activities of daily living and cardio-metabolic risk factors; and obese older women were more likely to be food-insecure and have depression. CONCLUSIONS: Our findings suggest that obesity may coexist with micronutrient inadequacy in older adults, especially among women.

Comparison of 4 Methods to Assess the Prevalence of Use and Estimates of Nutrient Intakes from Dietary Supplements among US Adults.

BACKGROUND: Accurate and reliable methods to assess prevalence of use of and nutrient intakes from dietary supplements (DSs) are critical for research, clinical practice, and public health monitoring. NHANES has been the primary source of DS usage patterns using an in-home inventory with a frequency-based DS and Prescription Medicine Questionnaire (DSMQ), but little is known regarding DS information obtained from 24-h dietary recalls (24HRs). METHODS: The objectives of this analysis were to compare results from 4 different methods for measuring DS use constructed from two data collection instruments (i.e., DSMQ and 24HR) and to determine the most comprehensive method for measuring the prevalence of use and estimating nutrient intakes from DS for selected nutrients. NHANES 2011-2014 data from US adults (aged ≥19 y; n = 11,451) were used to examine the 4 combinations of methods constructed for measuring the prevalence of use of and amount of selected nutrients from DSs (i.e., riboflavin, vitamin D, folate, magnesium, calcium): 1) DSMQ, 2) 24HR day 1, 3) two 24HRs (i.e., mean), and 4) DSMQ or at least one 24HR. RESULTS: Half of US adults reported DS use on the DSMQ (52%) and on two 24HRs (mean of 49%), as compared with a lower prevalence of DS use when using a single 24HR (43%) and a higher (57%) prevalence when combining the DSMQ with at least one 24HR. Mean nutrient intake estimates were highest using 24HR day 1. Mean supplemental calcium from the DSMQ or at least one 24HR was 372 mg/d, but 464 mg/d on the 24HR only. For vitamin D, the estimated intakes per consumption day were higher on the DSMQ (46 µg) and the DSMQ or at least one 24HR (44 µg) than those on the 24HR day 1 (32 µg) or the mean 24HR (31 µg). Fewer products were also classed as a default or reasonable match on the DSMQ than on the 24HR. CONCLUSIONS: A higher prevalence of use of DSs is obtained using frequency-based methods, whereas higher amounts of nutrients are reported from a 24HR. The home inventory results in greater accuracy for products reported. Collectively, these findings suggest that combining the DSMQ with at least one 24HR (i.e., DSMQ or at least one 24HR) is the most comprehensive method for assessing the prevalence of and estimating usual intake from DSs in US adults.This trial was registered at clinicaltrials.gov as NCT03400436.