Intergenerational transmission of sucralose and acesulfame-potassium from mothers to their infants via human milk: a pharmacokinetic study.

BACKGROUND: Low-calorie sweetener (LCS) consumption is prevalent among lactating women, yet infants' exposure to LCS in human milk is not well-characterized. OBJECTIVE: Conduct a pharmacokinetic study of sucralose and ace-K in mothers' milk and plasma over 72 hours, and in infants' plasma. METHODS: Following baseline blood and milk collection, mothers (n=40) consumed 20-ounces of diet cranberry juice, containing sucralose and ace-K. Blood samples were collected from the mother 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours after beverage ingestion, and milk was expressed at 1, 2, 3, 4, 6, 8, 12, and 24 hours post-ingestion. One blood sample was collected from each infant, the timing of which was determined using pharmacokinetics model-based simulation. Concentration-time profiles of LCS from mother's plasma and milk were analyzed using non-compartmental methods. RESULTS: Ace-K rapidly entered human milk with the largest observed concentration of 373.0 (CV 69%) ng/ml first detected 4 hours following diet beverage ingestion. Sucralose appeared in human milk 1-2 hours after diet beverage ingestion with the largest observed concentration of 7.2 (CV 63%) ng/ml first detected 7 hours post-ingestion. The mean 24-hour milk to plasma ratio (MPR) of ace-K was 1.75 (SD 1.37) with a mean relative infant dose (RID) of 1.59% (SD 1.72%). ace-K was detected in all infants' plasma with an average concentration of 9.2 (SD% 14.8) ng/ml approximately 6 hours after maternal beverage ingestion. The mean 24-hour MPR of sucralose was 0.15 (SD 0.06) with a mean RID of 0.04% (SD 0.02%). Sucralose was detected in only fifteen infants' plasma, and the average concentration was 5.0 (SD% 7.1) ng/ml, approximately 5 hours after diet beverage ingestion. CONCLUSIONS: Ace-K rapidly transfers from human milk into infants' circulation whereas sucralose was detected at much lower concentrations and in some but not all infants. Future research should investigate effects of early life sucralose and ace-K exposure via human milk on infants' health. TRIAL REGISTRATION: NCT05379270, https://classic. CLINICALTRIALS: gov/ct2/show/NCT05379270.

Understanding Factors that Influence Parents' Provision of Beverages to Their Children: A Qualitative Evidence Synthesis.

OBJECTIVE: Understand parental perceptions of beverages and factors influencing the beverage choices they make for their children. DATA SOURCE: A literature search was conducted using PubMed, Scopus, and CINAHL. STUDY INCLUSION AND EXCLUSION CRITERIA: Included studies contained qualitative data examining parents' perceptions of beverages or factors that influence their child's beverage consumption, were conducted in the United States between 2000 and 2022, written in English, and enrolled parents of children aged 18 years or younger. DATA EXTRACTION: Authors, titles, study aims, methods, qualitative results, and representative quotations were extracted using Covidence. DATA SYNTHESIS: Qualitative findings were independently coded by two coders. Codes were compared and discrepancies resolved through discussion with a third team member. Themes and sub-themes were identified, and representative quotations selected. RESULTS: 13 studies met inclusion criteria. Five major themes emerged: 1) factors that influence parents' provision of beverages to their children, 2) parents' concerns about sugar-sweetened beverages (SSBs), 3) barriers to limiting children's SSB consumption, 4) strategies to lower children's SSB consumption, and 5) parents' perceptions of beverage healthfulness. CONCLUSION: Though most parents are aware of unfavorable health effects of frequent SSB intake, environmental and sociocultural factors pose barriers to limiting their child's SSB consumption. Changes to policy and the food environment are needed to initiate and sustain reductions in SSB intake, along with continued nutrition education efforts.

Nonsugar Sweeteners-Time for Transparency and Caution.

This Viewpoint discusses the growing presence of nonsugar sweeteners (NSSs) in the food supply and mounting concerns about their use, which suggest that disclosure of the amounts of NSS in food and beverages and restrictions on their use in products marketed to children are warranted.

Consumption of sucralose- and acesulfame-potassium-containing diet soda alters the relative abundance of microbial taxa at the species level: findings of two pilot studies.

Sucralose and acesulfame-potassium consumption alters gut microbiota in rodents, with unclear effects in humans. We examined effects of three-times daily sucralose- and acesulfame-potassium-containing diet soda consumption for 1 (n = 17) or 8 (n = 8) weeks on gut microbiota composition in young adults. After 8 weeks of diet soda consumption, the relative abundance of Proteobacteria, specifically Enterobacteriaceae, increased; and, increased abundance of two Proteobacteria taxa was also observed after 1 week of diet soda consumption compared with sparkling water. In addition, three taxa in the Bacteroides genus increased following 1 week of diet soda consumption compared with sparkling water. The clinical relevance of these findings and effects of sucralose and acesulfame-potassium consumption on human gut microbiota warrant further investigation in larger studies. Clinical trial registration: NCT02877186 and NCT03125356.

Mothers' Experiences During the 2022 Infant Formula Shortage in Washington D.C.

INTRODUCTION: An unprecedented shortage of infant formula occurred in the United States (U.S.) in 2022 and posed widespread challenges to infant feeding nationwide. The purpose of this study is to investigate mothers' experiences during the 2022 infant formula shortage and its perceived impacts on infants' diet and health. METHODS: Mothers (n = 45) of infants under 8 months old from Washington D.C. were invited to participate in a virtual study meeting during the summer of 2022. Mothers completed surveys regarding their demographics, infants' anthropometrics, infant feeding practices, information they have received about infant feeding, and knowledge about infant feeding practices. They then participated in a qualitative interview about their experiences during the infant formula shortage. RESULTS: Overarching themes were: the shortage (1) had adverse impacts on mothers' mental and emotional health; (2) had significant financial and intangible costs; (3) led to changes in infant feeding practices; (4) social and family networks were helpful in navigating the shortage; and (5) mothers felt fortunate to have resources to breastfeed and/or obtain formula. DISCUSSION: The infant formula shortage adversely impacted mothers' mental and emotional health, and was costly, in terms of financial and intangible costs. Findings demonstrate the need to develop clinical and policy approaches to support mothers in feeding their infants and provide education about safe infant feeding practices.

The MILK study: Investigating intergenerational transmission of low-calorie sweeteners in breast milk.

Introduction: Forty-four percent of lactating women in the United States consume beverages containing low calorie sweeteners (LCS), and the presence of LCS in the food supply has continued to increase in recent years. While LCS are approved by the United States Food and Drug Administration (FDA) and are believed to be safe for human consumption, intergenerational LCS transmission and the health impacts of early life LCS exposure are severely understudied. Methods and analysis: In a tightly controlled, single site, prospective interventional study, mothers' plasma and breast milk, and infants' plasma will be collected from 40 mother-infant dyads over the course of 72 h, with rich sampling following maternal ingestion of a LCS sweetened beverage containing sucralose and acesulfame potassium (ace-K). Concentration-time data will be used to build maternal and infant pharmacokinetic models for future simulations and analysis. Conclusion: This study aims to measure LCS concentrations in breast milk, maternal plasma, and infant plasma, to gain insight into infant exposure and inform recommendations for LCS consumption during breastfeeding.

Effects of Low-Calorie Sweetener Restriction on Glycemic Variability and Cardiometabolic Health in Children with Type 1 Diabetes: Findings of a Pilot and Feasibility Study.

Low-calorie sweeteners (LCS) are commonly consumed by children with type 1 diabetes (T1D), yet their role in cardiometabolic health is unclear. This study examined the feasibility, acceptability, and preliminary effects of 12 weeks of LCS restriction among children with T1D. Children (n = 31) with T1D completed a two-week run-in (n = 28) and were randomly assigned to avoid LCS (LCS restriction, n = 15) or continue their usual LCS intake (n = 13). Feasibility was assessed using recruitment, retention, and adherence rates percentages. Acceptability was assessed through parents completing a qualitative interview (subset, n = 15) and a satisfaction survey at follow-up. Preliminary outcomes were between-group differences in change in average daily time-in-range (TIR) over 12 weeks (primary), and other measures of glycemic variability, lipids, inflammatory biomarkers, visceral adiposity, and dietary intake (secondary). Linear regression, unadjusted and adjusted for age, sex, race, and change in BMI, was used to compare mean changes in all outcomes between groups. LCS restriction was feasible and acceptable. No between-group differences in change in TIR or other measures of glycemic variability were observed. However, significant decreases in TNF-alpha (-0.23 ± 0.08 pg/mL) and improvements in cholesterol (-0.31 ± 0.18 mmol/L) and LDL (-0.60 ± 0.39 mmol/L) were observed with usual LCS intake, compared with LCS restriction. Those randomized to LCS restriction did not report increases in total or added sugar intake, and lower energy intake was reported in both groups (-190.8 ± 106.40 kcal LCS restriction, -245.3 ± 112.90 kcal usual LCS intake group). Decreases in percent energy from carbohydrates (-8.5 ± 2.61) and increases in percent energy from protein (3.2 ± 1.16) and fat (5.2 ± 2.02) were reported with usual LCS intake compared with LCS restriction. Twelve weeks of LCS restriction did not compromise glycemic variability or cardiometabolic outcomes in this small sample of youth with T1D. Further examination of LCS restriction among children with T1D is warranted.

Behavioral Patterns of Sugary Drink Consumption among African American Adolescents: A Pilot and Feasibility Study Using Ecological Momentary Assessment.

BACKGROUND: Sugary drinks (SDs) are the predominant contributors to added sugar intake among adolescents, with the highest intakes reported among African American adolescents. The objective of this pilot study was to examine the feasibility of using mobile phone-based ecological momentary assessment (EMA) to investigate, in real time, behavioral patterns of SD consumption among African American adolescents from low-income households. METHODS: Adolescents (n = 39, ages 12-17) attended a virtual meeting with a trained research assistant, which involved completion of surveys and training on responding to EMA prompts using a mobile phone application. On the seven subsequent days, adolescents were instructed to respond to researcher-initiated prompts three times daily, which queried their SD intake, location, social context, activities, stress, and mood. They were also asked to complete an analogous self-initiated survey each time they consumed SDs. RESULTS: SD consumption was reported on 219 of 582 (38%) researcher-initiated surveys and on 135 self-initiated SD consumption surveys, for a total of 354 instances of SD intake over the 7-day assessment period. The majority (69%) of the surveys were completed while at home. SD consumption was reported on 37%, 35%, and 41% of researcher-initiated surveys completed at their home, at the home of a friend or family member, or while in transit, respectively. CONCLUSIONS: These preliminary data indicate that mobile phone-based EMA is feasible for investigating SD intake behaviors among African American youth from low-income households and support the promise of EMA for investigating SD consumption in this population in larger samples of youth.

Non-Nutritive Sweeteners in Human Amniotic Fluid and Cord Blood: Evidence of Transplacental Fetal Exposure.

OBJECTIVE: This study aimed to investigate human fetal exposure to non-nutritive sweeteners (NNS) by analyzing amniotic fluid and umbilical cord blood. STUDY DESIGN: Concentrations of four NNS (acesulfame-potassium [ace-K], saccharin, steviol glucuronide, and sucralose) were measured in amniotic fluid (n = 13) and cord blood samples (n = 15) using liquid chromatography-mass spectrometry. Amniotic fluid samples were obtained for research purposes at the time of term elective cesarean birth or clinically indicated third trimester amnioreduction at Mercy Hospital for Women (Melbourne, Australia). All except four women were in the fasting state. Cord blood samples were obtained from an independent cohort of newborns whose mothers were enrolled in a separate clinical trial at the National Institutes of Health. RESULTS: Ten of 13 amniotic fluid samples contained at least one NNS (ace-K, saccharin, steviol glucuronide, and/or sucralose). Maximum amniotic fluid NNS concentrations of ace-K, saccharin, steviol glucuronide, and sucralose were 78.9, 55.9, 93.5, and 30.6 ng/mL, respectively. Ace-K and saccharin were present in 100% and 80% of the cord blood samples, with maximal concentrations of 6.5 and 2.7 ng/mL, respectively. Sucralose was not detected and steviol glucuronide was not measurable in any of the cord blood samples. CONCLUSION: Our results provide evidence of human transplacental transmission of NNS. Based on results predominantly obtained from rodent models, we speculate that NNS exposure may adversely influence the offsprings' metabolic health. Well-designed, prospective clinical trials are necessary to understand the impact of NNS intake during pregnancy on human development and long-term health. KEY POINTS: · NNS consumption during pregnancy has increased in recent years.. · Maternal NNS intake during pregnancy is associated with preterm birth and higher infant weight gain in epidemiologic studies.. · In rodents, in utero NNS exposure induces metabolic abnormalities in mothers and their offspring, alters offspring gut microbiota composition, and promotes sweet taste preference in adulthood.. · It is presently unknown whether and to what degree maternal NNS ingestion in humans leads to direct in utero exposure.. · This study provides the first evidence of in utero NNS exposure in humans and highlights the urgent need to investigate clinical consequences of early life NNS exposure on metabolism, weight, taste preference, and general health..

Impacts of the COVID-19 Pandemic on Pediatric Type 1 Diabetes Management: A Qualitative Study.

PURPOSE: The purpose of this study was to understand impacts of the coronavirus (COVID-19) pandemic on pediatric type 1 diabetes management. METHODS: In-depth qualitative interviews were conducted with 15 parents of children (age 6-12 years) with type 1 diabetes. Parents responded to 8 open-ended questions about their experiences managing their children's type 1 diabetes during the COVID-19 pandemic. All interviews were transcribed, coded, and analyzed using qualitative thematic methods. RESULTS: Parents reported both positive and negative aspects of managing their children's type 1 diabetes during the COVID-19 pandemic. Facilitators of diabetes management included spending more time together at home and enhanced convenience of telehealth appointments and online supply ordering. Parents also described difficulties managing their children's type 1 diabetes during the COVID-19 pandemic, including a lack of structure in their child's daily routine, which led to increases in sedentary behavior. Furthermore, they reported psychosocial challenges of type 1 diabetes management, which were exacerbated by the pandemic. CONCLUSION: While the COVID-19 pandemic was described as having overall positive impacts on pediatric type 1 diabetes management, efforts to support parents in increasing children's physical activity and reducing screen time are needed, along with readily accessible mental health resources for both parents and their children with type 1 diabetes.

Impacts of the COVID-19 Pandemic on Children's Sugary Drink Consumption: A Qualitative Study.

The coronavirus (COVID-19) pandemic has caused striking alterations to daily life, with important impacts on children's health. Spending more time at home and out of school due to COVID-19 related closures may exacerbate obesogenic behaviors among children, including consumption of sugary drinks (SDs). This qualitative study aimed to investigate effects of the pandemic on children's SD consumption and related dietary behaviors. Children 8-14 years old and their parent (n = 19 dyads) participated in an in-depth qualitative interview. Interviews were recorded, transcribed verbatim, and independently coded by two coders, after which, emergent themes and subthemes were identified and representative quotations selected. Although increases in children's SD and snack intake were almost unanimously reported by both children and their parents, increased frequency of cooking at home and preparation of healthier meals were also described. Key reasons for children's higher SD and snack intake were having unlimited access to SDs and snacks and experiencing boredom while at home. Parents also explained that the pandemic impacted their oversight of the child's SD intake, as many parents described loosening prior restrictions on their child's SD intake and/or allowing their child more autonomy to make their own dietary choices during the pandemic. These results call attention to concerning increases in children's SD and snack intake during the COVID-19 pandemic. Intervention strategies to improve the home food environment, including reducing the availability of SDs and energy-dense snacks and providing education on non-food related coping strategies are needed.

Stop the Pop: A Mixed-Methods Study Examining Children's Physical and Emotional Responses during Three Days of Sugary Drink Cessation.

Despite public health efforts to reduce sugary drink consumption, children's intake continues to exceed recommendations. While numerous barriers to lowering sugary drink consumption have been identified, aversive feelings during sugary drink cessation may further challenge sustained reduction in children's sugary drink consumption. Herein, we describe "Stop the Pop", an intervention to examine children's physical and emotional responses during three days of sugary drink cessation. Children (n = 150) ages 8-14, who reported habitual consumption of ≥12 ounces of sugary drinks daily, were instructed to avoid sweetened beverages for three days. At baseline and on each day of cessation, children completed a daily feelings questionnaire, and a subset of children (n = 30) also completed a qualitative interview following cessation. During sugary drink cessation, children reported physical and emotional improvements, including being less tired, angry, and annoyed; having less trouble sleeping; and less frequently arguing with others, getting in trouble, and getting mad. However, unfavorable responses, such as mood disturbances and having less energy, were reported by some participants. Our results suggest that children who habitually consume sugary drinks may experience physical and emotional improvements during short-term sugary drink cessation, although longer-term examination is needed and inter-individual variability in responses to cessation warrants further study.

Beverage Characteristics Perceived as Healthy among Hispanic and African-American Parents of Young Children.

BACKGROUND: It is recommended that children younger than 6 years of age avoid sugar-sweetened beverages (SSBs); yet, 25% of toddlers and 45% of preschool-aged children consume SSBs on a given day, with the highest intakes reported among Hispanic and African-American children. OBJECTIVE: To investigate characteristics that predominantly low-income Hispanic and African-American parents perceive to reflect a healthy beverage, and to examine the influence of these characteristics on parents' perceptions of the beverages they provide to their young children. DESIGN: This study consisted of two activities: a qualitative activity where parents (n = 102) were asked to report what characteristics they perceive to reflect a healthy beverage and a quantitative activity where parents (n = 96) indicated the extent to which each of the reported characteristics influence parents' perceptions of the beverages they provide to their young children. PARTICIPANTS AND SETTING: Hispanic and African-American parents of young children (younger than 6 years of age) were recruited from the District of Columbia metropolitan area. MAIN OUTCOME MEASURES: Beverage characteristics and influence scores. STATISICAL ANALYSES PERFORMED: Characteristics were categorized by the research team based on their perceived meaning. Perceived influence scores for each characteristic and category were compared across Hispanic and African-American parents using nonparametric, Mann-Whitney U tests, and false discovery rate adjustment was used to correct for multiple testing. RESULTS: The characteristics perceived to be most influential included those pertaining to perceived beverage sugar and sweetener content, being natural, and containing certain nutrients. Characteristics such as being homemade, made with fruit, and containing vitamins were reported to be more influential among Hispanic parents compared with African-American parents. CONCLUSIONS: Findings emphasize the need to address misperceptions about the healthfulness of beverages among Hispanic and African-American parents. Differences in the perceived influence of specific beverage characteristics across Hispanic and African-American parents underscore the importance of developing culturally relevant interventions to improve parents' beverage selection for their children.

Understanding Physical Activity Patterns Across the School Day in Urban Pre-Kindergarten and Elementary Schoolchildren.

PURPOSE: Despite recommendations that children accrue ≥60 min/day of moderate-to-vigorous physical activity (MVPA), numerous barriers may exist. We examined school-day MVPA patterns in lower-income children (pre-K to 5th grade) to determine whether they were meeting the minimum school-day guidelines of at least 30-min/day of MVPA and to identify opportunities for intervention. METHODS: Students (N = 629, pre-K-5th grade) from 4 urban schools wore Actigraph GT3X+ accelerometers over 2 school days. Mixed effects models evaluated sex- and grade-specific differences in MVPA and sedentary time. RESULTS: Only 34.6% of elementary and 25.3% of pre-K students met the school-time MVPA recommendation. Among elementary-aged children, boys accrued more MVPA than girls (30.8 ± 13.3 vs. 23.5 ± 10.7 min/day; p < 0.0001) with similar sex differences observed among pre-K children (51.3 ± 17.1 vs 41.9 ± 17.5 min/day; p < 0.001). Sedentary time also increased significantly with grade among elementary-aged children (207.9 ± 34.7 vs. 252.0 ± 36.1 min/day for those in 1st and 5th grade, respectively; p < 0.001), with girls accruing more sedentary time than boys (242.5 ± 48.2 vs. 233.8 ± 46.8 min/day; p < 0.0001). CONCLUSION: MVPA declines across elementary school years, with sex disparities observed as early as pre-K. Extended sedentary bouts and clustering of activity highlight opportunities for more movement throughout the school day.

Diet Beverage Intake during Lactation and Associations with Infant Outcomes in the Infant Feeding Practices Study II.

Consumption of diet beverages (DB) containing low-calorie sweeteners (LCS) is widespread in the United States. LCS are ingested by nursing infants upon maternal DB consumption, which may impact infants' weight and health. This study aims to examine cross-sectional associations between infants' LCS exposure via maternal DB intake during lactation and infants' health outcomes. Six hundred and eighty-two mother-infant dyads at three months postpartum, from the Infant Feeding Practices Study II, 2005-2007, were included in the analysis. Maternal DB consumption during lactation was estimated using the serving size and frequency of DB consumption reported on the diet history questionnaire. Infants' LCS exposure was estimated by multiplying maternal DB consumption and breastfeeding intensity. Infant outcomes included weight, weight-for-age and BMI-for-age z-scores, overweight, and gastrointestinal (GI) symptoms including diarrhea, reflux, and vomiting. Associations between infants' LCS exposure and continuous and categorical outcomes were examined using linear and logistic regressions adjusting for confounders, respectively. Forty-three percent of lactating women reported DB consumption. While no significant associations were observed between infants' LCS exposure and BMI-for-age or risk of overweight, infants' LCS exposure was associated with a 2.78-fold increased risk of vomiting (95% confidence interval 1.05-7.34). Potential adverse effects of LCS exposure on GI symptoms require further study, and null findings on infant weight should be interpreted with caution, given the small sample size. Additional research is needed to inform recommendations for or against DB consumption during lactation.

Dietary and Health Correlates of Sweetened Beverage Intake: Sources of Variability in the National Health and Nutrition Examination Survey (NHANES).

Recent studies using data from the National Health and Nutrition Examination Survey (NHANES) have used inconsistent approaches to identify and categorize beverages, especially those containing low-calorie sweeteners (LCS), also referred to as low-calorie sweetened beverages (LCSBs). Herein, we investigate the approaches used to identify and categorize LCSBs in recent analyses of NHANES data. We reviewed published studies examining LCS consumption in relation to dietary and health outcomes and extracted the methods used to categorize LCS as reported by the authors of each study. We then examined the extent to which these approaches reliably identified LCSBs using the Internet Archive Wayback Machine to examine beverage ingredients lists across three NHANES cycles (2011-2016). None of the four general strategies used appeared to include all LCSBs while also excluding all beverages that did not contain LCS. In some cases, the type of sweetener in the beverage consumed could not be clearly determined; we found 9, 16, and 18 of such "mixed" beverage identifiers in the periods 2011-2012, 2013-2014, and 2015-2016, respectively. Then, to illustrate how heterogeneity in beverage categorization may impact the outcomes of published analyses, we compared results of a previously published analysis with outcomes when "mixed" beverages were grouped either all as LCSBs or all as sugary beverages. Our results suggest that caution is warranted in design and interpretation of studies using NHANES data to examine dietary and health correlates of sweetened beverage intake.

Feasibility and acceptability of a randomized controlled trial to investigate withdrawal symptoms in response to caffeinated sugary drink cessation among children.

BACKGROUND: Sugary drinks (SDs) are key contributors to excess added sugar intake and the predominant source of caffeine among children. Chronic caffeine intake causes dependence, and evidence for sugar dependence is emerging. Development of withdrawal symptoms may pose an obstacle to SD cessation among children. We examined the feasibility and acceptability of a three-arm randomized controlled trial (RCT) designed to investigate withdrawal symptoms resulting from replacement of children's usual caffeinated SD intake with either caffeine-free alternatives or caffeine-free and sugar-free alternatives, compared with continued consumption of caffeinated SDs. METHODS: Twenty-nine children 8-12 years old, who consumed ≥12 ounces caffeinated SDs daily, enrolled. The two-week RCT required three in-person meetings and daily completion of electronic questionnaires to assess withdrawal symptoms and intervention adherence. Children were randomized to replace their usual caffeinated SD consumption with 1) caffeine-free alternatives, 2) caffeine-free and sugar-free alternatives, or 3) caffeinated SDs (control), provided by the study team. Feasibility and acceptability were assessed quantitatively and qualitatively. RESULTS: Twenty-eight participants (97%) completed the study. Adherence was high, with 73% reporting compliance with beverage assignments, and 76% completing all questionnaires. In qualitative interviews at follow-up, children described feelings of importance and commitment, and parents did not find the procedures to be overly burdensome. While challenges to adherence were reported (e.g., child wanting other SDs, time commitment), participants described innovative strategies (e.g., designating a place for study drinks in the refrigerator) to maintain adherence. CONCLUSION: Results indicated high levels of RCT feasibility and acceptability. The reported barriers and strategies for adherence will inform modifications required to design a larger and longer-term trial investigating withdrawal symptoms after SD cessation in children.

Rationale and design of DRINK-T1D: A randomized clinical trial of effects of low-calorie sweetener restriction in children with type 1 diabetes.

BACKGROUND: Low-calorie sweeteners (LCSs) provide sweetness without sugar or calories and are used to replace added sugars by many children with type 1 diabetes (T1D). However, the role of LCSs in diabetes management and cardiometabolic health is unclear. OBJECTIVE: The Diabetes Research in Kids Study (DRINK-T1D) aims to investigate effects of LCS restriction on glycemic variability, visceral adiposity, lipid profiles, and systemic inflammation among children 6-12 years old with T1D. METHODS: Children with T1D, who report habitual consumption of foods and beverages containing LCSs, are recruited from the Washington Nationals Diabetes Care Complex (DCC) at Children's National Hospital (CNH) in Washington, DC. Following a phone screening and two-week run-in period involving continuation of usual LCS intake, children are randomized to 12 weeks of LCS restriction (replacement of diet beverages with still or sparkling water and avoidance of other sources of LCSs) or continued usual LCS intake (control). The primary outcome is the difference in change in glycemic variability in the LCS restriction group versus the control group. Change in glycemic variability will be assessed as the difference in daily average time-in-range (TIR), measured using continuous glucose monitoring (CGM) during two weeks at the end of the 12-week intervention, compared with during the two-week run-in period prior to randomization. Participants also complete a variety of anthropometric, metabolic, dietary, and behavioral assessments throughout the 14-week study. CONCLUSIONS: DRINK-T1D is an innovative, randomized controlled trial, evaluating effects of LCS restriction on glycemic variability and cardiometabolic health in children with T1D. Findings of DRINK-T1D will support or challenge the common practice of recommending LCS use in this patient population and will have clinically relevant implications for pediatric T1D management. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04385888.