Feasibility of Delivering a 5-Day Normobaric Hypoxia Breathing in Healthy Volunteers in a Hospital Setting.

BACKGROUND: Beneficial effects of breathing at FIO2 < 0.21 on disease outcomes have been reported in previous preclinical and clinical studies. However, the safety and intra-hospital feasibility of breathing hypoxic gas for 5 d have not been established. In this study, we examined the physiologic effects of breathing a gas mixture with FIO2 as low as 0.11 in 5 healthy volunteers. METHODS: All 5 subjects completed the study, spending 5 consecutive days in a hypoxic tent, where the ambient oxygen level was lowered in a stepwise manner over 5 d, from FIO2 of 0.16 on the first day to FIO2 of 0.11 on the fifth day of the study. All the subjects returned to an environment at room air on the sixth day. The subjects' SpO2 , heart rate, and breathing frequency were continuously recorded, along with daily blood sampling, neurologic evaluations, transthoracic echocardiography, and mental status assessments. RESULTS: Breathing hypoxia concentration dependently caused profound physiologic changes, including decreased SpO2 and increased heart rate. At FIO2 of 0.14, the mean SpO2 was 92%; at FIO2 of 0.13, the mean SpO2 was 93%; at FIO2 of 0.12, the mean SpO2 was 88%; at FIO2 of 0.11, the mean SpO2 was 85%; and, finally, at an FIO2 of 0.21, the mean SpO2 was 98%. These changes were accompanied by increased erythropoietin levels and reticulocyte counts in blood. All 5 subjects concluded the study with no adverse events. No subjects exhibited signs of mental status changes or pulmonary hypertension. CONCLUSIONS: Results of the current physiologic study suggests that, within a hospital setting, delivering FIO2 as low as 0.11 is feasible and safe in healthy subjects, and provides the foundation for future studies in which therapeutic effects of hypoxia breathing are tested.

Expectations from a Home Cooking Program: Qualitative Analyses of Perceptions from Participants in "Action" and "Contemplation" Stages of Change, before Entering a Bi-Center Randomized Controlled Trial.

Home cooking is an emerging strategy to improve nutrition; however, the literature lacks reports about patient expectations from culinary interventions. Personalized medicine utilizes knowledge about a person's genes; yet, behavioral factors, such as participant "readiness" to make a change, may also impact treatment preferences and outcomes. The purpose is to explore the expectations of participants in different stages of change from a home cooking intervention. Participants were recruited to a randomized controlled trial evaluating the impact of a home cooking intervention on weight. Stage of change assessed by a validated University of Rhode Island Change Assessment scale and expectations through an open-ended questionnaire. Sixteen (21%) participants were in the action stage of change, and 59 (79%) were in the contemplation stage. Participants from both groups shared similar expectations to achieve healthy eating and lifestyle goals and to adopt sustainable change. However, action group expectations also included expanding existing culinary knowledge and change of habits; the contemplation group expectations also included acquiring culinary knowledge, improving self-regulatory skills, and obtaining guidance and support. While action group participants were looking to expand existing knowledge and techniques, contemplation group participants were focusing on acquiring culinary knowledge and skills. This can potentially contribute to developing effective, personalized nutrition interventions.

Retail Food Equivalents for Post-Oral Immunotherapy Dosing in the Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food-Allergic Children and Adults (OUtMATCH) Clinical Trial.

BACKGROUND: Patients with food allergy may be advised to introduce specific foods into their diets, both to increase tolerance gradually and as next steps after completing oral immunotherapy or other therapeutic interventions. However, the safe use of retail foods depends on the ability to establish the specific allergen protein content of these foods. OBJECTIVE: To develop a systematic approach to estimate the protein content of peanut, milk, egg, wheat, cashew, hazelnut, and walnut in a variety of retail food equivalents for each allergen and associated patient education materials. METHOD: We created an algorithm that used a multistep process with information from product food labels, nutrient databases, independent weighing and measuring of foods, and information provided by manufacturers, including certificates of analysis, and e-mail communication to estimate the allergen protein content of multiple retail foods for each of seven allergens. Once a variety of retail food equivalents for each allergen and allergen serving size was determined, we developed participant education handouts, which were reviewed by study teams at 10 food allergy centers, the National Institute of Allergy and Infectious Diseases, and the Consortium for Food Allergy Research coordinating center. After 1 year of use, multiple queries were addressed and the retail food equivalents and educational materials were reviewed and edited. RESULTS: We identified a variety of retail food equivalents for seven allergens at six serving sizes, and created 48 unique patient education materials. CONCLUSION: Our results provide extensive guidance on a variety of retail equivalents for seven foods, and a method to estimate retail food protein equivalents systematically with ongoing reassessment.

How Accurately Can We Recall the Timing of Food Intake? A Comparison of Food Times from Recall-Based Survey Questions and Daily Food Records.

BACKGROUND: There currently are no standard, low-cost, and validated methods to assess the timing of food intake. OBJECTIVES: The aim of this study was to validate simple, recall-based questions that can characterize food timing in free-living populations. METHODS: The concordance between recall-based survey questions and food times estimated from multiple daily food records was assessed in 249 generally healthy, free-living adults from the Shift Work, Heredity, Insulin, and Food Timing (SHIFT) Study. At baseline, participants were asked: "At what time do you first start and stop eating on weekdays/workdays and weekends/non-workdays?" and "At what time do you have your main meal on weekdays/workdays and weekends/non-workdays?" Participants were then asked to complete ≤14 d of food records noting the start time of each eating occasion. The timing of the first, last, and main (largest percentage calories) eating occasions were determined from food records. Wilcoxon matched pairs signed rank and Kendall's coefficient of concordance were used to compare differences and determine agreements between the methods for these food timing parameters, as well as for the midpoint between first and last eating occasion. RESULTS: Eating occasions on work and free days showed significant agreements between the 2 methods, except for the main eating occasion on free days. Significant agreements were generally modest and ranged from 0.16 (workdays main eating occasion) to 0.45 (workdays first eating occasion). Generally, times based on recall were later than those estimated from food records, and the differences in estimated times were smaller on workdays compared with free days, and smaller for the first compared with the last eating occasion. Main eating occasions from food records often varied between lunch and dinner times, contributing to low concordance with recalled times. CONCLUSIONS: Modest agreements were found between food times derived from simple, recall-based survey questions and food times estimated from multiple-day food records. Single administration of these questions can effectively characterize the overall timing of eating occasions within a population for chrononutrition research purposes.

Impaired insulin signaling in unaffected siblings and patients with first-episode psychosis.

Patients with psychotic disorders are at high risk for type 2 diabetes mellitus, and there is increasing evidence that patients display glucose metabolism abnormalities before significant antipsychotic medication exposure. In the present study, we examined insulin action by quantifying insulin sensitivity in first-episode psychosis (FEP) patients and unaffected siblings, compared to healthy individuals, using a physiological-based model and comprehensive assessment battery. Twenty-two unaffected siblings, 18 FEP patients, and 15 healthy unrelated controls were evaluated using a 2-h oral glucose tolerance test (OGTT), with 7 samples of plasma glucose and serum insulin concentration measurements. Insulin sensitivity was quantified using the oral minimal model method. Lipid, leptin, free fatty acids, and inflammatory marker levels were also measured. Anthropometric, nutrient, and activity assessments were conducted; total body composition and fat distribution were determined using whole-body dual-energy X-ray absorptiometry. Insulin sensitivity significantly differed among groups (F = 6.01 and 0.004), with patients and siblings showing lower insulin sensitivity, compared to controls (P = 0.006 and 0.002, respectively). Body mass index, visceral adipose tissue area (cm2), lipids, leptin, free fatty acids, inflammatory markers, and activity ratings were not significantly different among groups. There was a significant difference in nutrient intake with lower total kilocalories/kilogram body weight in patients, compared to siblings and controls. Overall, the findings suggest that familial abnormal glucose metabolism or a primary insulin signaling pathway abnormality is related to risk for psychosis, independent of disease expression and treatment effects. Future studies should examine underlying biological mechanisms of insulin signaling abnormalities in psychotic disorders.

Associations of anthropometry and lifestyle factors with HDL subspecies according to apolipoprotein C-III.

The presence of apoC-III on HDL impairs HDL's inverse association with coronary heart disease (CHD). Little is known about modifiable factors explaining variation in HDL subspecies defined according to apoC-III. The aim was to investigate cross-sectional associations of anthropometry and lifestyle with HDL subspecies in 3,631 participants from the Diet, Cancer, and Health study originally selected for a case-cohort study (36% women; age 50-65 years) who were all free of CHD. Greater adiposity and less activity were associated with higher HDL containing apoC-III and lower HDL lacking apoC-III. Per each 15 cm higher waist circumference, the level of HDL containing apoC-III was 2.8% higher (95% CI: 0.4, 5.3; P = 0.024) and the level of HDL not containing apoC-III was 4.7% lower (95% CI: -6.0, -3.4; P = <0.0001). Associations for physical activity were most robust to multivariable modeling. Each 20 metabolic equivalent task hours per week reported higher physical activity was associated with 0.9% (95% CI: -1.7, -0.1; P = 0.031) lower HDL containing apoC-III and 0.5% higher (95% CI: 0.1, 1.0; P = 0.029) HDL lacking apoC-III. Lower alcohol consumption was associated with lower HDL lacking apoC-III (percent difference per 15 g/day: 1.58 (95% CI: 0.84, 2.32; P = <0.0001). Adiposity and sedentary lifestyle were associated with a less favorable HDL subspecies profile.