Rationale, Design and Participants Baseline Characteristics of a Crossover Randomized Controlled Trial of the Effect of Replacing SSBs with NSBs versus Water on Glucose Tolerance, Gut Microbiome and Cardiometabolic Risk in Overweight or Obese Adult SSB Consumer: Strategies to Oppose SUGARS with Non-Nutritive Sweeteners or Water (STOP Sugars NOW) Trial and Ectopic Fat Sub-Study.

BACKGROUND: Health authorities are near universal in their recommendation to replace sugar-sweetened beverages (SSBs) with water. Non-nutritive sweetened beverages (NSBs) are not as widely recommended as a replacement strategy due to a lack of established benefits and concerns they may induce glucose intolerance through changes in the gut microbiome. The STOP Sugars NOW trial aims to assess the effect of the substitution of NSBs (the "intended substitution") versus water (the "standard of care substitution") for SSBs on glucose tolerance and microbiota diversity. DESIGN AND METHODS: The STOP Sugars NOW trial (NCT03543644) is a pragmatic, "head-to-head", open-label, crossover, randomized controlled trial conducted in an outpatient setting. Participants were overweight or obese adults with a high waist circumference who regularly consumed ≥1 SSBs daily. Each participant completed three 4-week treatment phases (usual SSBs, matched NSBs, or water) in random order, which were separated by ≥4-week washout. Blocked randomization was performed centrally by computer with allocation concealment. Outcome assessment was blinded; however, blinding of participants and trial personnel was not possible. The two primary outcomes are oral glucose tolerance (incremental area under the curve) and gut microbiota beta-diversity (weighted UniFrac distance). Secondary outcomes include related markers of adiposity and glucose and insulin regulation. Adherence was assessed by objective biomarkers of added sugars and non-nutritive sweeteners and self-report intake. A subset of participants was included in an Ectopic Fat sub-study in which the primary outcome is intrahepatocellular lipid (IHCL) by 1H-MRS. Analyses will be according to the intention to treat principle. BASELINE RESULTS: Recruitment began on 1 June 2018, and the last participant completed the trial on 15 October 2020. We screened 1086 participants, of whom 80 were enrolled and randomized in the main trial and 32 of these were enrolled and randomized in the Ectopic Fat sub-study. The participants were predominantly middle-aged (mean age 41.8 ± SD 13.0 y) and had obesity (BMI of 33.7 ± 6.8 kg/m2) with a near equal ratio of female: male (51%:49%). The average baseline SSB intake was 1.9 servings/day. SSBs were replaced with matched NSB brands, sweetened with either a blend of aspartame and acesulfame-potassium (95%) or sucralose (5%). CONCLUSIONS: Baseline characteristics for both the main and Ectopic Fat sub-study meet our inclusion criteria and represent a group with overweight or obesity, with characteristics putting them at risk for type 2 diabetes. Findings will be published in peer-reviewed open-access medical journals and provide high-level evidence to inform clinical practice guidelines and public health policy for the use NSBs in sugars reduction strategies. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03543644.

Child food portion sizes in the home environment: how do parents decide?

The consumption of larger portion sizes (PS) of food has been implicated in the increased prevalence of childhood obesity. The home is usually the first place children learn about food, however, little is known about how parents determine child PS in the home environment. This narrative review aimed to explore parental beliefs, decisions, strategies and barriers to the provision of appropriate food PS for children in the home environment. Results indicate that parental decisions on child food PS are based on the amounts they serve themselves, personal intuition and knowledge of child appetite. Owing to the habitual nature of food provision, parental decisions on child PS may be taken without conscious thought and/or could be part of a complex decision-making process influenced by several interlinked factors, including parental childhood mealtime experiences, other family members and child weight status. Strategies to determine child-appropriate PS include modelling the desired PS behaviour, use of unit-based food packaging and PS estimation aids, and providing the child with a degree of autonomy to rely on their own appetite cues. A lack of knowledge/awareness of PS guidance is a key barrier identified by parents to the provision of age-appropriate PS, warranting the inclusion of salient child-appropriate PS guidance within national dietary recommendations. Further home-based interventions to improve the provision of appropriate child PS are required, leveraged on parental strategies already in use, as outlined in this review.

Development and Feasibility of a Family-Based Health Behavior Intervention Using Intelligent Personal Assistants: Randomized Controlled Trial.

BACKGROUND: Intelligent personal assistants such as Amazon Echo and Google Home have become increasingly integrated into the home setting and, therefore, may facilitate behavior change via novel interactions or as an adjunct to conventional interventions. However, little is currently known about their potential role in this context. OBJECTIVE: This feasibility study aims to develop the Intelligent Personal Assistant Project (IPAP) and assess the acceptability and feasibility of this technology for promoting and maintaining physical activity and other health-related behaviors in both parents and children. METHODS: This pilot feasibility study was conducted in 2 phases. For phase 1, families who were attending a community-based weight management project were invited to participate, whereas phase 2 recruited families not currently receiving any additional intervention. Families were randomly allocated to either the intervention group (received a smart speaker for use in the family home) or the control group. The IPAP intervention aimed to promote positive health behaviors in the family setting through utilization of the functions of a smart speaker and its linked intelligent personal assistant. Data were collected on recruitment, retention, outcome measures, intervention acceptability, device interactions, and usage. RESULTS: In total, 26 families with at least one child aged 5 to 12 years were recruited, with 23 families retained at follow-up. Across phase 1 of the intervention, families interacted with the intelligent personal assistant a total of 65 times. Although device interactions across phase 2 of the intervention were much higher (312 times), only 10.9% (34/312) of interactions were coded as relevant (related to diet, physical activity or well-being). Focus groups highlighted that the families found the devices acceptable and easy to use and felt that the prompts or reminders were useful in prompting healthier behaviors. Some further intervention refinements in relation to the timing of prompts and integrating feedback alongside the devices were suggested by families. CONCLUSIONS: Using intelligent personal assistants to deliver health-related messages and information within the home is feasible, with high levels of engagement reported by participating families. This novel feasibility study highlights important methodological considerations that should inform future trials testing the effectiveness of intelligent personal assistants in promoting positive health-related behaviors. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16792534; http://www.isrctn.com/ISRCTN16792534.

A Novel Urinary Biomarker Approach Reveals Widespread Exposure to Multiple Low-Calorie Sweeteners in Adults.

BACKGROUND: Observational investigations into the health impacts of low-calorie sweeteners (LCSs) in humans fail to adequately identify or fully characterize LCS consumption. OBJECTIVES: We aimed to utilize a novel biomarker approach to investigate exposure to 5 LCSs and to test whether reported low-calorie sweetened beverage (LCSB) consumption effectively identifies exposure to LCSs in adults. METHODS: In this cross-sectional analysis, 2 population studies were conducted in adults. Urinary excretions of 5 LCSs, namely acesulfame-K, saccharin, cyclamate, sucralose, and steviol glycosides, were simultaneously determined using LC tandem-MS. In Study 1, previously collected 24-h urine samples (n = 357) were analyzed. In Study 2, previously collected 24-h urine samples (n = 79) were analyzed to compare urinary excretions of LCSs with self-reported LCSB consumption for identifying LCS exposure. Exposure to LCSs was characterized using descriptive statistics and chi-square tests were performed to assess associations between age-groups and LCS excretion, and to assess the proportion of individuals identified as LCS consumers using biomarker data or reported LCSB consumption. RESULTS: A total of 341 adults (45% men) and 79 adults (39% men) were included in the final analysis of Studies 1 and 2, respectively. In Study 1, >96% of samples contained ≥1 LCS and almost 60% contained ≥3 LCSs. A greater proportion of younger adults (<40 y old) excreted ≥3 LCSs than older adults (>40 y old) (P < 0.001). In Study 2, a much higher prevalence of LCS consumption was observed using biomarker data (92%) than reported LCSB consumption (6%) (P < 0.001). CONCLUSIONS: This work indicates widespread exposure to LCSs, suggesting that population-based research to date into LCS exposure and health may be flawed. Therefore, a urinary biomarker approach offers considerable potential for more robust investigations in this area.

Biomarker approaches to assessing intakes and health impacts of sweeteners: challenges and opportunities.

The term 'sweeteners' encompasses both nutritive and non-nutritive sweeteners, which when added to food/beverages, can enhance the flavour and other functional properties of food/beverage products. This review considers how dietary biomarker approaches may enhance current understanding of nutritive sweetener (namely free sugars) and non-nutritive or low-energy sweetener (LES) intakes and how these may impact health. Recent public health strategies to reduce free sugar consumption will help contribute to challenging sugar intake targets. Robust evaluation is needed to determine the effectiveness of these approaches to reducing free sugar consumption. LES provides a sweet taste without the addition of appreciable energy and can help maintain the palatability of reformulated products. All LES undergo rigorous safety evaluations prior to approval for use. Whilst intervention data suggest LES can be beneficial for health (relating to weight status and glycaemic control), debate persists on their use and findings from population-based research are mixed, in part because of potential contributing factors such as reverse causality. Additionally, assessments often consider only certain sources of LES (e.g. LES-beverages) and/or LES as a homogeneous group despite differing biological fates, thus not adequately capturing intakes of individual LES or allowing for reliable estimation of overall intakes. Urinary biomarker approaches developed/investigated for sweetener consumption have the potential to overcome existing limitations of dietary data by providing more objective intake data, thereby enhancing population-based research. In conclusion, such biomarker approaches to the concomitant study of free sugars and LES intakes are timely and represent interesting developments in an area of significant public health interest.

Biomarkers of intake for coffee, tea, and sweetened beverages.

Non-alcoholic beverages are important sources of nutrients and bioactive compounds that may influence human health and increase or decrease the risk of chronic diseases. A wide variety of beverage constituents are absorbed in the gut, found in the systemic circulation and excreted in urine. They may be used as compliance markers in intervention studies or as biomarkers of intake to improve measurements of beverage consumption in cohort studies and reveal new associations with disease outcomes that may have been overlooked when using dietary questionnaires. Here, biomarkers of intake of some major non-alcoholic beverages-coffee, tea, sugar-sweetened beverages, and low-calorie-sweetened beverages-are reviewed. Results from dietary intervention studies and observational studies are reviewed and analyzed, and respective strengths and weaknesses of the various identified biomarkers discussed. A variety of compounds derived from phenolic acids, alkaloids, and terpenes were shown to be associated with coffee intake and trigonelline and cyclo(isoleucylprolyl) showed a particularly high specificity for coffee intake. Epigallocatechin and 4'-O-methylepigallocatechin appear to be the most sensitive and specific biomarkers for green or black tea, while 4-O-methylgallic acid may be used to assess black tea consumption. Intake of sugar-sweetened beverages has been assessed through the measurement of carbon-13 enrichment of whole blood or of blood alanine in North America where sugar from sugarcane or corn is used as a main ingredient. The most useful biomarkers for low-calorie-sweetened beverages are the low-calorie sweeteners themselves. Further studies are needed to validate these biomarkers in larger and independent populations and to further evaluate their specificity, reproducibility over time, and fields of application.

Ibero⁻American Consensus on Low- and No-Calorie Sweeteners: Safety, Nutritional Aspects and Benefits in Food and Beverages.

International scientific experts in food, nutrition, dietetics, endocrinology, physical activity, paediatrics, nursing, toxicology and public health met in Lisbon on 2⁻4 July 2017 to develop a Consensus on the use of low- and no-calorie sweeteners (LNCS) as substitutes for sugars and other caloric sweeteners. LNCS are food additives that are broadly used as sugar substitutes to sweeten foods and beverages with the addition of fewer or no calories. They are also used in medicines, health-care products, such as toothpaste, and food supplements. The goal of this Consensus was to provide a useful, evidence-based, point of reference to assist in efforts to reduce free sugars consumption in line with current international public health recommendations. Participating experts in the Lisbon Consensus analysed and evaluated the evidence in relation to the role of LNCS in food safety, their regulation and the nutritional and dietary aspects of their use in foods and beverages. The conclusions of this Consensus were: (1) LNCS are some of the most extensively evaluated dietary constituents, and their safety has been reviewed and confirmed by regulatory bodies globally including the World Health Organisation, the US Food and Drug Administration and the European Food Safety Authority; (2) Consumer education, which is based on the most robust scientific evidence and regulatory processes, on the use of products containing LNCS should be strengthened in a comprehensive and objective way; (3) The use of LNCS in weight reduction programmes that involve replacing caloric sweeteners with LNCS in the context of structured diet plans may favour sustainable weight reduction. Furthermore, their use in diabetes management programmes may contribute to a better glycaemic control in patients, albeit with modest results. LNCS also provide dental health benefits when used in place of free sugars; (4) It is proposed that foods and beverages with LNCS could be included in dietary guidelines as alternative options to products sweetened with free sugars; (5) Continued education of health professionals is required, since they are a key source of information on issues related to food and health for both the general population and patients. With this in mind, the publication of position statements and consensus documents in the academic literature are extremely desirable.

Application of Liquid Chromatography-Tandem Mass Spectrometry To Determine Urinary Concentrations of Five Commonly Used Low-Calorie Sweeteners: A Novel Biomarker Approach for Assessing Recent Intakes?

Although the use of low-calorie sweeteners (LCSs) is widespread, methods of assessing consumption within free-living populations have inherent limitations. Five commonly consumed LCSs, namely, acesulfame-K, saccharin, sucralose, cyclamate, and steviol glycosides, are excreted via the urine, and therefore a urinary biomarker approach may provide more objective LCS intake data. A LC-ESI-MS/MS method of simultaneously determining acesulfame-K, saccharin, sucralose, cyclamate, and the excretory metabolite of steviol glycosides, steviol glucuronide, in human urine was developed and validated. Linearity was observed over a concentration range of 10-1000 ng/mL with coefficients of determination ranging from 0.9969 to 0.9997. Accuracy ranged from 92 to 104%, and intrabatch and interday precisions were within acceptable limits with %CV below 8% for all compounds. A double-blind, randomized crossover dose-response study was conducted to assess the usefulness of urinary LCS excretions (from both fasting spot and a full 24-h urine collection) for investigating recent intakes. Both modes of sampling were useful for distinguishing between the three short-term intakes of acesulfame-K, saccharin, cyclamates, and steviol glycosides (p < 0.001), whereas for sucralose, urinary concentrations were useful for distinguishing between low (0.1% ADI) and high doses (10% ADI) only (p < 0.001). In summary, this biomarker approach may be useful for assessing intakes of five commonly consumed LCSs.