Gut-microbiota-targeted diets modulate human immune status.

Diet modulates the gut microbiome, which in turn can impact the immune system. Here, we determined how two microbiota-targeted dietary interventions, plant-based fiber and fermented foods, influence the human microbiome and immune system in healthy adults. Using a 17-week randomized, prospective study (n = 18/arm) combined with -omics measurements of microbiome and host, including extensive immune profiling, we found diet-specific effects. The high-fiber diet increased microbiome-encoded glycan-degrading carbohydrate active enzymes (CAZymes) despite stable microbial community diversity. Although cytokine response score (primary outcome) was unchanged, three distinct immunological trajectories in high-fiber consumers corresponded to baseline microbiota diversity. Alternatively, the high-fermented-food diet steadily increased microbiota diversity and decreased inflammatory markers. The data highlight how coupling dietary interventions to deep and longitudinal immune and microbiome profiling can provide individualized and population-wide insight. Fermented foods may be valuable in countering the decreased microbiome diversity and increased inflammation pervasive in industrialized society.

Changes in soluble LDL receptor and lipoprotein fractions in response to diet in the DIETFITS weight loss study.

Circulating levels of the soluble ligand-binding ectodomain of the LDL receptor (sLDLR) that is proteolytically cleaved from the cell surface have been shown to correlate with plasma triglycerides, but the lipid and lipoprotein effects of longitudinal changes in sLDLR have not been examined. We sought to assess associations between changes in sLDLR and detailed lipoprotein measurements between baseline and 6 months in participants in the DIETFITS (Diet Intervention Examining The Factors Interacting with Treatment Success) weight loss trial who were randomly assigned to the low-fat (n = 225) or low-carbohydrate (n = 236) diet arms. sLDLR was assayed using a proteomic procedure, lipids and apoprotein (apo) B and apoAI were measured by standard assays, and lipoprotein particle subfractions were quantified by ion mobility methodology. Changes in sLDLR were significantly positively associated with changes in plasma cholesterol, triglycerides, apoB, large-sized and medium-sized VLDL, and small and very small LDL, and inversely with changes in large LDL and HDL. The lipoprotein subfraction associations with sLDLR were independent of age, sex, diet, and BMI, but all except for large LDL were reduced to insignificance when adjusted for triglyceride change. Principal component analysis identified three independent clusters of changes in lipoprotein subfractions that accounted for 78% of their total variance. Change in sLDLR was most strongly correlated with change in the principal component that was loaded positively with large VLDL and small and very small LDL and negatively with large LDL and HDL. In conclusion, sLDLR is a component of a cluster of lipids and lipoproteins that are characteristic of atherogenic dyslipidemia.

Popular Dietary Patterns: Alignment With American Heart Association 2021 Dietary Guidance: A Scientific Statement From the American Heart Association.

The evolution of dietary guidelines from isolated nutrients to broader dietary pattern recommendations results from growing knowledge of the synergy between nutrients and their food sources as they influence health. Macronutrient and micronutrient needs can be met by consuming various dietary patterns, but guidance is often required to facilitate population-wide adherence to wise food choices to achieve a healthy dietary pattern. This is particularly true in this era with the proliferation of nutrition misinformation and misplaced emphasis. In 2021, the American Heart Association issued a scientific statement outlining key principles of a heart-healthy dietary pattern that could be operationalized in various ways. The objective of this scientific statement is to assess alignment of commonly practiced US dietary patterns with the recently published American Heart Association criteria, to determine clinical and cultural factors that affect long-term adherence, and to propose approaches for adoption of healthy dietary patterns. This scientific statement is intended to serve as a tool for clinicians and consumers to evaluate whether these popular dietary pattern(s) promote cardiometabolic health and suggests factors to consider when adopting any pattern to improve alignment with the 2021 American Heart Association Dietary Guidance. Numerous patterns strongly aligned with 2021 American Heart Association Dietary Guidance (ie, Mediterranean, DASH [Dietary Approaches to Stop Hypertension], pescetarian, vegetarian) can be adapted to reflect personal and cultural preferences and budgetary constraints. Thus, optimal cardiovascular health would be best supported by developing a food environment that supports adherence to these patterns wherever food is prepared or consumed.

Food Is Medicine: A Presidential Advisory From the American Heart Association.

Unhealthy diets are a major impediment to achieving a healthier population in the United States. Although there is a relatively clear sense of what constitutes a healthy diet, most of the US population does not eat healthy food at rates consistent with the recommended clinical guidelines. An abundance of barriers, including food and nutrition insecurity, how food is marketed and advertised, access to and affordability of healthy foods, and behavioral challenges such as a focus on immediate versus delayed gratification, stand in the way of healthier dietary patterns for many Americans. Food Is Medicine may be defined as the provision of healthy food resources to prevent, manage, or treat specific clinical conditions in coordination with the health care sector. Although the field has promise, relatively few studies have been conducted with designs that provide strong evidence of associations between Food Is Medicine interventions and health outcomes or health costs. Much work needs to be done to create a stronger body of evidence that convincingly demonstrates the effectiveness and cost-effectiveness of different types of Food Is Medicine interventions. An estimated 90% of the $4.3 trillion annual cost of health care in the United States is spent on medical care for chronic disease. For many of these diseases, diet is a major risk factor, so even modest improvements in diet could have a significant impact. This presidential advisory offers an overview of the state of the field of Food Is Medicine and a road map for a new research initiative that strategically approaches the outstanding questions in the field while prioritizing a human-centered design approach to achieve high rates of patient engagement and sustained behavior change. This will ideally happen in the context of broader efforts to use a health equity-centered approach to enhance the ways in which our food system and related policies support improvements in health.

Unveiling the epigenetic impact of vegan vs. omnivorous diets on aging: insights from the Twins Nutrition Study (TwiNS).

BACKGROUND: Geroscience focuses on interventions to mitigate molecular changes associated with aging. Lifestyle modifications, medications, and social factors influence the aging process, yet the complex molecular mechanisms require an in-depth exploration of the epigenetic landscape. The specific epigenetic clock and predictor effects of a vegan diet, compared to an omnivorous diet, remain underexplored despite potential impacts on aging-related outcomes. METHODS: This study examined the impact of an entirely plant-based or healthy omnivorous diet over 8 weeks on blood DNA methylation in paired twins. Various measures of epigenetic age acceleration (PC GrimAge, PC PhenoAge, DunedinPACE) were assessed, along with system-specific effects (Inflammation, Heart, Hormone, Liver, and Metabolic). Methylation surrogates of clinical, metabolite, and protein markers were analyzed to observe diet-specific shifts. RESULTS: Distinct responses were observed, with the vegan cohort exhibiting significant decreases in overall epigenetic age acceleration, aligning with anti-aging effects of plant-based diets. Diet-specific shifts were noted in the analysis of methylation surrogates, demonstrating the influence of diet on complex trait prediction through DNA methylation markers. An epigenome-wide analysis revealed differentially methylated loci specific to each diet, providing insights into the affected pathways. CONCLUSIONS: This study suggests that a short-term vegan diet is associated with epigenetic age benefits and reduced calorie intake. The use of epigenetic biomarker proxies (EBPs) highlights their potential for assessing dietary impacts and facilitating personalized nutrition strategies for healthy aging. Future research should explore the long-term effects of vegan diets on epigenetic health and overall well-being, considering the importance of proper nutrient supplementation. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05297825.

Strengthening US Food Policies and Programs to Promote Equity in Nutrition Security: A Policy Statement From the American Heart Association.

Nutritionally inadequate dietary intake is a leading contributor to chronic cardiometabolic diseases. Differences in dietary quality contribute to socioeconomic and racial and ethnic health disparities. Food insecurity, a household-level social or economic condition of limited access to sufficient food, is a common cause of inadequate dietary intake. Although US food assistance policies and programs are designed to improve food security, there is growing consensus that they should have a broader focus on nutrition security. In this policy statement, we define nutrition security as an individual or household condition of having equitable and stable availability, access, affordability, and utilization of foods and beverages that promote well-being and prevent and treat disease. Despite existing policies and programs, significant gaps remain for achieving equity in nutrition security across the life span. We provide recommendations for expanding and improving current food assistance policies and programs to achieve nutrition security. These recommendations are guided by several overarching principles: emphasizing nutritional quality, improving reach, ensuring optimal utilization, improving coordination across programs, ensuring stability of access to programs across the life course, and ensuring equity and dignity for access and utilization. We suggest a critical next step will be to develop and implement national measures of nutrition security that can be added to the current US food security measures. Achieving equity in nutrition security will require coordinated and sustained efforts at the federal, state, and local levels. Future advocacy, innovation, and research will be needed to expand existing food assistance policies and programs and to develop and implement new policies and programs that will improve cardiovascular health and reduce disparities in chronic disease.

Friend or Foe? The Role of Animal-Source Foods in Healthy and Environmentally Sustainable Diets.

Scientific and political discussions around the role of animal-source foods (ASFs) in healthy and environmentally sustainable diets are often polarizing. To bring clarity to this important topic, we critically reviewed the evidence on the health and environmental benefits and risks of ASFs, focusing on primary trade-offs and tensions, and summarized the evidence on alternative proteins and protein-rich foods. ASFs are rich in bioavailable nutrients commonly lacking globally and can make important contributions to food and nutrition security. Many populations in Sub-Saharan Africa and South Asia could benefit from increased consumption of ASFs through improved nutrient intakes and reduced undernutrition. Where consumption is high, processed meat should be limited, and red meat and saturated fat should be moderated to lower noncommunicable disease risk-this could also have cobenefits for environmental sustainability. ASF production generally has a large environmental impact; yet, when produced at the appropriate scale and in accordance with local ecosystems and contexts, ASFs can play an important role in circular and diverse agroecosystems that, in certain circumstances, can help restore biodiversity and degraded land and mitigate greenhouse gas emissions from food production. The amount and type of ASF that is healthy and environmentally sustainable will depend on the local context and health priorities and will change over time as populations develop, nutritional concerns evolve, and alternative foods from new technologies become more available and acceptable. Efforts by governments and civil society organizations to increase or decrease ASF consumption should be considered in light of the nutritional and environmental needs and risks in the local context and, importantly, integrally involve the local stakeholders impacted by any changes. Policies, programs, and incentives are needed to ensure best practices in production, curb excess consumption where high, and sustainably increase consumption where low.

SWAP-MEAT Athlete (study with appetizing plant-food, meat eating alternatives trial) - investigating the impact of three different diets on recreational athletic performance: a randomized crossover trial.

BACKGROUND: Plant-based diets are known to be beneficial for cardiovascular health and promote environmental sustainability. However, many athletes avoid plant-based diets due to concerns of protein inadequacy. OBJECTIVES: To investigate the impact of two predominately plant-based diets-whole food plant-based (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet, favoring red meat and poultry (Animal), on endurance and muscular strength. METHODS: 12 recreational runners and 12 resistance trainers were assigned to three diets-WFPB, PBMA, and Animal-for 4 weeks each, in random order. Primary outcomes for runners (12-minute timed run) and resistance trainers (composite machine strength) were collected at baseline and after diets, along with secondary performance outcomes and dietary data. RESULTS: 22 recreational athletes completed the study (age: 26.2 ± 4.4 years; sex: 10 female, 12 male; BMI: 23.1 ± 2.4 kg/m2). Mean differences in 12-minute timed run - WFPB vs. Animal (- 23.4 m; 95% CI: - 107 to 60.0 m) and PBMA vs. Animal (- 2.9 m; 95% CI: - 119 to 113 m) - were not significant. Mean percent differences in composite machine strength - WFPB vs. Animal (- 2.7%; 95% CI: - 5.8 to 0.4% and PBMA vs. Animal (- 0.7%; 95% CI: - 3.5 to 2.2%) - were not significant. Average protein intake for all diets met International Society for Sports Nutrition recommendations. CONCLUSIONS: Our findings suggest recreational athletes can maintain athletic performance on both an omnivorous diet and two diets that are predominately plant-based. TRIAL REGISTRATION: NCT05472701. Retrospectively registered.

Examining differences between overweight women and men in 12-month weight loss study comparing healthy low-carbohydrate vs. low-fat diets.

BACKGROUND/OBJECTIVES: Biological sex factors and sociocultural gender norms affect the physiology and behavior of weight loss. However, most diet intervention studies do not report outcomes by sex, thereby impeding reproducibility. The objectives of this study were to compare 12-month changes in body weight and composition in groups defined by diet and sex, and adherence to a healthy low carbohydrate (HLC) vs. healthy low fat (HLF) diet. PARTICIPANTS/METHODS: This was a secondary analysis of the DIETFITS trial, in which 609 overweight/obese nondiabetic participants (age, 18-50 years) were randomized to a 12-month HLC (n = 304) or HLF (n = 305) diet. Our first aim concerned comparisons in 12-month changes in weight, fat mass, and lean mass by group with appropriate adjustment for potential confounders. The second aim was to assess whether or not adherence differed by diet-sex group (HLC women n = 179, HLC men n = 125, HLF women n = 167, HLF men n = 138). RESULTS: 12-month changes in weight (p < 0.001) were different by group. HLC produced significantly greater weight loss, as well as greater loss of both fat mass and lean mass, than HLF among men [-2.98 kg (-4.47, -1.50); P < 0.001], but not among women. Men were more adherent to HLC than women (p = 0.02). Weight loss estimates within group remained similar after adjusting for adherence, suggesting adherence was not a mediator. CONCLUSIONS: By reporting outcomes by sex significant weight loss differences were identified between HLC and HLF, which were not recognized in the original primary analysis. These findings highlight the need to consider sex in the design, analysis, and reporting of diet trials.

Sustainable Diets for Cardiovascular Disease Prevention and Management.

PURPOSE OF REVIEW: Healthy dietary patterns are recommended for prevention of cardiovascular disease, which remains the leading cause of morbidity and mortality globally. In this review, we discuss dietary patterns that are not only optimal for CVD prevention and management but also sustainable in maximizing health, environmental, and economic benefits. RECENT FINDINGS: The growing literature on sustainable diets in the context of environmental sustainability includes subtopics of climate change, land use, biodiversity loss, freshwater use, and reactive nitrogen emissions. Similarly, economic sustainability, beyond the retail cost of food, extends to healthcare costs and the economic costs of environmental destruction related to current agricultural practices and food choices. Dietary patterns that are high in plant foods and low in animal foods could maximize health, environmental, and economic benefits; however, questions remain about how to best promote these patterns to achieve wider adoption in an environmentally and economically sustainable way.

Interventions to reduce meat consumption by appealing to animal welfare: Meta-analysis and evidence-based recommendations.

Reducing meat consumption may improve human health, curb environmental damage, and limit the large-scale suffering of animals raised in factory farms. Most attention to reducing consumption has focused on restructuring environments where foods are chosen or on making health or environmental appeals. However, psychological theory suggests that interventions appealing to animal welfare concerns might operate on distinct, potent pathways. We conducted a systematic review and meta-analysis evaluating the effectiveness of these interventions. We searched eight academic databases and extensively searched grey literature. We meta-analyzed 100 studies assessing interventions designed to reduce meat consumption or purchase by mentioning or portraying farm animals, that measured behavioral or self-reported outcomes related to meat consumption, purchase, or related intentions, and that had a control condition. The interventions consistently reduced meat consumption, purchase, or related intentions at least in the short term with meaningfully large effects (meta-analytic mean risk ratio [RR] = 1.22; 95% CI: [1.13, 1.33]). We estimated that a large majority of population effect sizes (71%; 95% CI: [59%, 80%]) were stronger than RR = 1.1 and that few were in the unintended direction. Via meta-regression, we identified some specific characteristics of studies and interventions that were associated with effect size. Risk-of-bias assessments identified both methodological strengths and limitations of this literature; however, results did not differ meaningfully in sensitivity analyses retaining only studies at the lowest risk of bias. Evidence of publication bias was not apparent. In conclusion, animal welfare interventions preliminarily appear effective in these typically short-term studies of primarily self-reported outcomes. Future research should use direct behavioral outcomes that minimize the potential for social desirability bias and are measured over long-term follow-up.

Increasing Vegetable Intake by Emphasizing Tasty and Enjoyable Attributes: A Randomized Controlled Multisite Intervention for Taste-Focused Labeling.

Healthy food labels tout health benefits, yet most people prioritize tastiness in the moment of food choice. In a preregistered intervention, we tested whether taste-focused labels compared with health-focused labels increased vegetable intake at five university dining halls throughout the United States. Across 137,842 diner decisions, 185 days, and 24 vegetable types, taste-focused labels increased vegetable selection by 29% compared with health-focused labels and by 14% compared with basic labels. Vegetable consumption also increased. Supplementary studies further probed the mediators, moderators, and boundaries of these effects. Increased expectations of a positive taste experience mediated the effect of taste-focused labels on vegetable selection. Moderation tests revealed greater effects in settings that served tastier vegetable recipes. Taste-focused labels outperformed labels that merely contained positive words, fancy words, or lists of ingredients. Together, these studies show that emphasizing tasty and enjoyable attributes increases vegetable intake in real-world settings in which vegetables compete with less healthy options.

Self-Reported Measures of Discretionary Salt Use Accurately Estimated Sodium Intake Overall but not in Certain Subgroups of US Adults from 3 Geographic Regions in the Salt Sources Study.

BACKGROUND: Excess sodium intake can increase blood pressure, and high blood pressure is a major risk factor for cardiovascular disease. Accurate population sodium intake estimates are essential for monitoring progress toward reduction, but data are limited on the amount of sodium consumed from discretionary salt. OBJECTIVES: The aim of this study was to compare measured sodium intake from salt added at the table with that estimated according to the Healthy People 2020 (HP 2020) methodology. METHODS: Data were analyzed from the 2014 Salt Sources Study, a cross-sectional convenience sample of 450 white, black, Asian, and Hispanic adults living in Alabama, Minnesota, and California. Sodium intake from foods and beverages was assessed for each participant through the use of 24-h dietary recalls. Estimated sodium intake from salt used at the table was assessed from self-reported frequency and estimated amounts from a previous study (HP 2020 methodology). Measured intake was assessed through the use of duplicate salt samples collected on recall days. RESULTS: Among all study participants, estimated and measured mean sodium intakes from salt added at the table were similar, with a nonsignificant difference of 8.9 mg/d (95% CI: -36.6, 54.4 mg/d). Among participants who were non-Hispanic Asian, Hispanic, had a bachelor's degree or higher education, lived in California or Minnesota, did not report hypertension, or had normal BMI, estimated mean sodium intake was 77-153 mg/d greater than measured intake (P < 0.05). The estimated mean sodium intake was 186-300 mg/d lower than measured intake among participants who were non-Hispanic black, had a high school degree or less, or reported hypertension (P < 0.05). CONCLUSIONS: The HP 2020 methodology for estimating sodium consumed from salt added at the table may be appropriate for the general US adult population; however, it underestimates intake in certain population subgroups, particularly non-Hispanic black, those with a high school degree or less, or those with self-reported hypertension. This study was registered at clinicaltrials.gov as NCT02474693.

Sources of Sodium in US Adults From 3 Geographic Regions.

BACKGROUND: Most US adults consume excess sodium. Knowledge about the dietary sources of sodium intake is critical to the development of effective reduction strategies. METHODS: A total of 450 adults were recruited from 3 geographic locations: Birmingham, AL (n=150); Palo Alto, CA (n=150); and the Minneapolis-St. Paul, MN (n=150), metropolitan areas. Equal numbers of women and men from each of 4 race/ethnic groups (blacks, Asians, Hispanics, and non-Hispanic whites) were targeted for recruitment. Four record-assisted 24-hour dietary recalls were collected from each participant with special procedures, which included the collection of duplicate samples of salt added to food at the table and in home food preparation. RESULTS: Sodium added to food outside the home was the leading source of sodium, accounting for more than two thirds (70.9%) of total sodium intake in the sample. Although the proportion of sodium from this source was smaller in some subgroups, it was the leading contributor for all subgroups. Contribution ranged from 66.3% for those with a high school level of education or less to 75.0% for those 18 to 29 years of age. Sodium inherent to food was the next highest contributor (14.2%), followed by salt added in home food preparation (5.6%) and salt added to food at the table (4.9%). Home tap water consumed as a beverage and dietary supplement and nonprescription antacids contributed minimally to sodium intake (<0.5% each). CONCLUSIONS: Sodium added to food outside the home accounted for ≈70% of dietary sodium intake. This finding is consistent with the 2010 Institute of Medicine recommendation for reduction of sodium in commercially processed foods as the primary strategy to reduce sodium intake in the United States. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02474693.

Effect of Low-Fat vs Low-Carbohydrate Diet on 12-Month Weight Loss in Overweight Adults and the Association With Genotype Pattern or Insulin Secretion: The DIETFITS Randomized Clinical Trial.

Importance: Dietary modification remains key to successful weight loss. Yet, no one dietary strategy is consistently superior to others for the general population. Previous research suggests genotype or insulin-glucose dynamics may modify the effects of diets. Objective: To determine the effect of a healthy low-fat (HLF) diet vs a healthy low-carbohydrate (HLC) diet on weight change and if genotype pattern or insulin secretion are related to the dietary effects on weight loss. Design, Setting, and Participants: The Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) randomized clinical trial included 609 adults aged 18 to 50 years without diabetes with a body mass index between 28 and 40. The trial enrollment was from January 29, 2013, through April 14, 2015; the date of final follow-up was May 16, 2016. Participants were randomized to the 12-month HLF or HLC diet. The study also tested whether 3 single-nucleotide polymorphism multilocus genotype responsiveness patterns or insulin secretion (INS-30; blood concentration of insulin 30 minutes after a glucose challenge) were associated with weight loss. Interventions: Health educators delivered the behavior modification intervention to HLF (n = 305) and HLC (n = 304) participants via 22 diet-specific small group sessions administered over 12 months. The sessions focused on ways to achieve the lowest fat or carbohydrate intake that could be maintained long-term and emphasized diet quality. Main Outcomes and Measures: Primary outcome was 12-month weight change and determination of whether there were significant interactions among diet type and genotype pattern, diet and insulin secretion, and diet and weight loss. Results: Among 609 participants randomized (mean age, 40 [SD, 7] years; 57% women; mean body mass index, 33 [SD, 3]; 244 [40%] had a low-fat genotype; 180 [30%] had a low-carbohydrate genotype; mean baseline INS-30, 93 µIU/mL), 481 (79%) completed the trial. In the HLF vs HLC diets, respectively, the mean 12-month macronutrient distributions were 48% vs 30% for carbohydrates, 29% vs 45% for fat, and 21% vs 23% for protein. Weight change at 12 months was -5.3 kg for the HLF diet vs -6.0 kg for the HLC diet (mean between-group difference, 0.7 kg [95% CI, -0.2 to 1.6 kg]). There was no significant diet-genotype pattern interaction (P = .20) or diet-insulin secretion (INS-30) interaction (P = .47) with 12-month weight loss. There were 18 adverse events or serious adverse events that were evenly distributed across the 2 diet groups. Conclusions and Relevance: In this 12-month weight loss diet study, there was no significant difference in weight change between a healthy low-fat diet vs a healthy low-carbohydrate diet, and neither genotype pattern nor baseline insulin secretion was associated with the dietary effects on weight loss. In the context of these 2 common weight loss diet approaches, neither of the 2 hypothesized predisposing factors was helpful in identifying which diet was better for whom. Trial Registration: clinicaltrials.gov Identifier: NCT01826591.

Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

BACKGROUND: Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. METHODS: Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. RESULTS: Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. CONCLUSIONS: These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

Iterative development of Vegethon: a theory-based mobile app intervention to increase vegetable consumption.

BACKGROUND: Mobile technology may serve as a cost-effective and scalable tool for delivering behavioral nutrition interventions. This research sought to iteratively develop a theory-driven mobile app, Vegethon, to increase vegetable consumption. METHODS: Development of Vegethon followed phases outlined by the IDEAS framework: 1) empathize with users (qualitative interviews, n = 18); 2) specify target behavior; 3) ground in behavioral theory; 4) ideate implementation strategies; 5) prototype potential products; 6) gather user feedback (qualitative interviews, n = 14; questionnaire, n = 41); 7) build minimum viable product; and 8) pilot potential efficacy and usability (pilot RCT, n = 17). Findings from each phase informed subsequent phases. The target population that informed intervention development was 18-50 years of age, had BMIs of 28-40 kg/m(2), and lived in the geographical area surrounding Stanford University. A full description of the final version of Vegethon is included in the paper. RESULTS: Qualitative findings that shaped initial intervention conception were: participants' interests in accountability without judgment; their desire for simple and efficient dietary self-monitoring; and the importance of planning meals in advance. Qualitative findings identified during intervention refinement were the need for a focus on vegetable self-monitoring; inclusion of vegetable challenges; simplification of features; advice and inspiration for eating vegetables; reminder notifications; and peer comparison. Pilot RCT findings suggested the initial efficacy, acceptance, and feasibility of the intervention. The final version of Vegethon enabled easy self-monitoring of vegetable consumption and included a range of features designed to engage the user (e.g., surprise challenges; leaderboard; weekly reports). Vegethon was coded for its inclusion of 18 behavior change techniques (BCTs) (e.g., goal setting; feedback; social comparison; prompts/cues; framing/reframing; identity). CONCLUSIONS: Vegethon is a theory-based, user-informed mobile intervention that was systematically developed using the IDEAS framework. Vegethon targets increased vegetable consumption among overweight adults and is currently being evaluated in a randomized controlled efficacy trial. TRIAL REGISTRATION: Clinical Trials.gov: NCT01826591.

IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior.

Developing effective digital interventions to change health behavior has been a challenging goal for academics and industry players alike. Guiding intervention design using the best combination of approaches available is necessary if effective technologies are to be developed. Behavioral theory, design thinking, user-centered design, rigorous evaluation, and dissemination each have widely acknowledged merits in their application to digital health interventions. This paper introduces IDEAS, a step-by-step process for integrating these approaches to guide the development and evaluation of more effective digital interventions. IDEAS is comprised of 10 phases (empathize, specify, ground, ideate, prototype, gather, build, pilot, evaluate, and share), grouped into 4 overarching stages: Integrate, Design, Assess, and Share (IDEAS). Each of these phases is described and a summary of theory-based behavioral strategies that may inform intervention design is provided. The IDEAS framework strives to provide sufficient detail without being overly prescriptive so that it may be useful and readily applied by both investigators and industry partners in the development of their own mHealth, eHealth, and other digital health behavior change interventions.

Effect of raw milk on lactose intolerance: a randomized controlled pilot study.

PURPOSE: This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk. METHODS: We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen (H2) breath testing. Participants underwent 3, 8-day milk phases (raw vs 2 controls: pasteurized, soy) in randomized order separated by 1-week washout periods. On days 1 and 8 of each phase, milk consumption was 473 mL (16 oz); on days 2 to 7, milk dosage increased daily by 118 mL (4 oz), beginning with 118 mL (4 oz) on day 2 and reaching 710 mL (24 oz) on day 7. Outcomes were area under the breath H2 curve (AUC H2) and self-reported symptom severity (visual analog scales: flatulence/gas, audible bowel sounds, abdominal cramping, diarrhea). RESULTS: AUC H2 (mean ± standard error of the mean) was higher for raw vs pasteurized on day 1 (113 ± 21 vs 71 ± 12 ppm·min·10(-2), respectively, P = .01) but not day 8 (72 ± 14 vs 74 ± 15 ppm·min·10(-2), respectively, P = .9). Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage (P >.7). AUC H2 and symptom severities were higher for both dairy milks compared with soy milk. CONCLUSIONS: Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption. These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance.