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Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial

Popp, Collin J; Hu, Lu; Kharmats, Anna Y; Curran, Margaret; Berube, Lauren; Wang, Chan; Pompeii, Mary Lou; Illiano, Paige; St-Jules, David E; Mottern, Meredith; Li, Huilin; Williams, Natasha; Schoenthaler, Antoinette; Segal, Eran; Godneva, Anastasia; Thomas, Diana; Bergman, Michael; Schmidt, Ann Marie; Sevick, Mary Ann
Importance:Interindividual variability in postprandial glycemic response (PPGR) to the same foods may explain why low glycemic index or load and low-carbohydrate diet interventions have mixed weight loss outcomes. A precision nutrition approach that estimates personalized PPGR to specific foods may be more efficacious for weight loss. Objective:To compare a standardized low-fat vs a personalized diet regarding percentage of weight loss in adults with abnormal glucose metabolism and obesity. Design, Setting, and Participants:The Personal Diet Study was a single-center, population-based, 6-month randomized clinical trial with measurements at baseline (0 months) and 3 and 6 months conducted from February 12, 2018, to October 28, 2021. A total of 269 adults aged 18 to 80 years with a body mass index (calculated as weight in kilograms divided by height in meters squared) ranging from 27 to 50 and a hemoglobin A1c level ranging from 5.7% to 8.0% were recruited. Individuals were excluded if receiving medications other than metformin or with evidence of kidney disease, assessed as an estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration equation, to avoid recruiting patients with advanced type 2 diabetes. Interventions:Participants were randomized to either a low-fat diet (<25% of energy intake; standardized group) or a personalized diet that estimates PPGR to foods using a machine learning algorithm (personalized group). Participants in both groups received a total of 14 behavioral counseling sessions and self-monitored dietary intake. In addition, the participants in the personalized group received color-coded meal scores on estimated PPGR delivered via a mobile app. Main Outcomes and Measures:The primary outcome was the percentage of weight loss from baseline to 6 months. Secondary outcomes included changes in body composition (fat mass, fat-free mass, and percentage of body weight), resting energy expenditure, and adaptive thermogenesis. Data were collected at baseline and 3 and 6 months. Analysis was based on intention to treat using linear mixed modeling. Results:Of a total of 204 adults randomized, 199 (102 in the personalized group vs 97 in the standardized group) contributed data (mean [SD] age, 58 [11] years; 133 women [66.8%]; mean [SD] body mass index, 33.9 [4.8]). Weight change at 6 months was -4.31% (95% CI, -5.37% to -3.24%) for the standardized group and -3.26% (95% CI, -4.25% to -2.26%) for the personalized group, which was not significantly different (difference between groups, 1.05% [95% CI, -0.40% to 2.50%]; P = .16). There were no between-group differences in body composition and adaptive thermogenesis; however, the change in resting energy expenditure was significantly greater in the standardized group from 0 to 6 months (difference between groups, 92.3 [95% CI, 0.9-183.8] kcal/d; P = .05). Conclusions and Relevance:A personalized diet targeting a reduction in PPGR did not result in greater weight loss compared with a low-fat diet at 6 months. Future studies should assess methods of increasing dietary self-monitoring adherence and intervention exposure. Trial Registration:ClinicalTrials.gov Identifier: NCT03336411.
PMID: 36169954
ISSN: 2574-3805
CID: 5334302

Soluble Receptor for Advanced Glycation End Products (sRAGE) Isoforms Predict Changes in Resting Energy Expenditure in Adults with Obesity during Weight Loss

Popp, Collin J; Zhou, Boyan; Manigrasso, Michaele B; Li, Huilin; Curran, Margaret; Hu, Lu; St-Jules, David E; Alemán, José O; Vanegas, Sally M; Jay, Melanie; Bergman, Michael; Segal, Eran; Sevick, Mary A; Schmidt, Ann M
Background/UNASSIGNED:Accruing evidence indicates that accumulation of advanced glycation end products (AGEs) and activation of the receptor for AGEs (RAGE) play a significant role in obesity and type 2 diabetes. The concentrations of circulating RAGE isoforms, such as soluble RAGE (sRAGE), cleaved RAGE (cRAGE), and endogenous secretory RAGE (esRAGE), collectively sRAGE isoforms, may be implicit in weight loss and energy compensation resulting from caloric restriction. Objectives/UNASSIGNED:We aimed to evaluate whether baseline concentrations of sRAGE isoforms predicted changes (∆) in body composition [fat mass (FM), fat-free mass (FFM)], resting energy expenditure (REE), and adaptive thermogenesis (AT) during weight loss. Methods/UNASSIGNED:Data were collected during a behavioral weight loss intervention in adults with obesity. At baseline and 3 mo, participants were assessed for body composition (bioelectrical impedance analysis) and REE (indirect calorimetry), and plasma was assayed for concentrations of sRAGE isoforms (sRAGE, esRAGE, cRAGE). AT was calculated using various mathematical models that included measured and predicted REE. A linear regression model that adjusted for age, sex, glycated hemoglobin (HbA1c), and randomization arm was used to test the associations between sRAGE isoforms and metabolic outcomes. Results/UNASSIGNED:) experienced modest and variable weight loss over 3 mo. Although baseline sRAGE isoforms did not predict changes in ∆FM or ∆FFM, all baseline sRAGE isoforms were positively associated with ∆REE at 3 mo. Baseline esRAGE was positively associated with AT in some, but not all, AT models. The association between sRAGE isoforms and energy expenditure was independent of HbA1c, suggesting that the relation was unrelated to glycemia. Conclusions/UNASSIGNED:This study demonstrates a novel link between RAGE and energy expenditure in human participants undergoing weight loss.This trial was registered at clinicaltrials.gov as NCT03336411.
PMCID:9071542
PMID: 35542387
ISSN: 2475-2991
CID: 5214412

Temporal Eating Patterns and Eating Windows among Adults with Overweight or Obesity

Popp, Collin J; Curran, Margaret; Wang, Chan; Prasad, Malini; Fine, Keenan; Gee, Allen; Nair, Nandini; Perdomo, Katherine; Chen, Shirley; Hu, Lu; St-Jules, David E; Manoogian, Emily N C; Panda, Satchidananda; Sevick, Mary Ann; Laferrère, Blandine
We aim to describe temporal eating patterns in a population of adults with overweight or obesity. In this cross-sectional analysis, data were combined from two separate pilot studies during which participants entered the timing of all eating occasions (>0 kcals) for 10-14 days. Data were aggregated to determine total eating occasions, local time of the first and last eating occasions, eating window, eating midpoint, and within-person variability of eating patterns. Eating patterns were compared between sexes, as well as between weekday and weekends. Participants (n = 85) had a median age of 56 ± 19 years, were mostly female (>70%), white (56.5%), and had a BMI of 31.8 ± 8.0 kg/m2. The median eating window was 14 h 04 min [12 h 57 min-15 h 21 min], which was significantly shorter on the weekend compared to weekdays (p < 0.0001). Only 13.1% of participants had an eating window <12 h/d. Additionally, there was greater irregularity with the first eating occasion during the week when compared to the weekend (p = 0.0002). In conclusion, adults with overweight or obesity have prolonged eating windows (>14 h/d). Future trials should examine the contribution of a prolonged eating window on adiposity independent of energy intake.
PMCID:8705992
PMID: 34960035
ISSN: 2072-6643
CID: 5108062

Feasibility and Acceptability of mHealth Interventions for Managing Hyperphosphatemia in Patients Undergoing Hemodialysis

St-Jules, David E; Woolf, Kathleen; Goldfarb, David S; Pompeii, Mary Lou; Li, Huilin; Wang, Chan; Mattoo, Aditya; Marcum, Zachary A; Sevick, Mary Ann
OBJECTIVE:The objective of the study was to evaluate the feasibility and acceptability of mobile health (mHealth) phosphorus management programs in hemodialysis (HD) patients. METHODS:Patients receiving thrice-weekly HD who had 3-month average serum phosphorus of >5.5 mg/dL were randomized to one of the three self-directed phosphorus management programs delivered using tablet PCs: (1) educational videos and handouts (Education), (2) education intervention plus mobile self-monitoring with email feedback (Monitoring), or (3) education and monitoring interventions plus social cognitive theory-based behavioral videos (Combined). Feasibility and acceptability were assessed based on enrollment and retention and training needs (feasibility) and adherence to self-monitoring and reported satisfaction (acceptability). RESULTS:Of 312 patients, 56 expressed interest, and 40 were enrolled. The majority of participants (80%) completed the 6-month study; none withdrew for intervention-related reasons. The Monitoring and Combined groups received 44 ± 15 minutes of technology training, which was considered adequate by most (75%). Self-monitoring rates were initially high, with 78% and 71% of the participants recording at least one meal and phosphate binder in week 1, respectively, but decreased over time to 15% and 9% in the final week. Most participants reported that self-monitoring helped them stay motivated (64%), track nutrients (80%), and understand how to change diet (76%), and nearly two-thirds of participants (64%) stated that they would like to continue using the tablet PC to manage their health. However, few participants (16%) indicated that self-monitoring was worth the effort. The Monitoring and Combined groups did not differ from the Education group in study outcomes. CONCLUSION/CONCLUSIONS:Although the mHealth programs were generally well received, self-monitoring rates decreased substantially over time and were unaffected by social cognitive theory-based videos. Self-directed mHealth programs may be a useful adjunct to standard care but should be compared to more resource intensive programs (e.g., involving more "live" contact with a dietitian) to determine overall cost-effectiveness and role in HD care.
PMID: 33160812
ISSN: 1532-8503
CID: 4664642

Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE): A Randomized Clinical Trial [Meeting Abstract]

Young, I. R.; Lam, R.; Kwon, S.; Crowley, G.; Riggs, J.; Ostrofsky, D.; Nayar, C.; Zeig-Owens, R.; Schwartz, T. M.; Colbeth, H. L.; Mikhail, M.; Veerappan, A.; Pompeii, M.; St-Jules, D. E.; Liu, M.; Prezant, D. J.; Sevick, M. A.; Nolan, A.
ISI:000685468902597
ISSN: 1073-449x
CID: 5519102

Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE) Protocol: A Randomized Clinical Trial

Kwon, Sophia; Riggs, Jessica; Crowley, George; Lam, Rachel; Young, Isabel R; Nayar, Christine; Sunseri, Maria; Mikhail, Mena; Ostrofsky, Dean; Veerappan, Arul; Zeig-Owens, Rachel; Schwartz, Theresa; Colbeth, Hilary; Liu, Mengling; Pompeii, Mary Lou; St-Jules, David; Prezant, David J; Sevick, Mary Ann; Nolan, Anna
Fire Department of New York (FDNY) rescue and recovery workers exposed to World Trade Center (WTC) particulates suffered loss of forced expiratory volume in 1 s (FEV1). Metabolic Syndrome increased the risk of developing WTC-lung injury (WTC-LI). We aim to attenuate the deleterious effects of WTC exposure through a dietary intervention targeting these clinically relevant disease modifiers. We hypothesize that a calorie-restricted Mediterranean dietary intervention will improve metabolic risk, subclinical indicators of cardiopulmonary disease, quality of life, and lung function in firefighters with WTC-LI. To assess our hypothesis, we developed the Food Intake REstriction for Health OUtcome Support and Education (FIREHOUSE), a randomized controlled clinical trial (RCT). Male firefighters with WTC-LI and a BMI > 27 kg/m2 will be included. We will randomize subjects (1:1) to either: (1) Low Calorie Mediterranean (LoCalMed)-an integrative multifactorial, technology-supported approach focused on behavioral modification, nutritional education that will include a self-monitored diet with feedback, physical activity recommendations, and social cognitive theory-based group counseling sessions; or (2) Usual Care. Outcomes include reduction in body mass index (BMI) (primary), improvement in FEV1, fractional exhaled nitric oxide, pulse wave velocity, lipid profiles, targeted metabolic/clinical biomarkers, and quality of life measures (secondary). By implementing a technology-supported LoCalMed diet our FIREHOUSE RCT may help further the treatment of WTC associated pulmonary disease.
PMID: 32916985
ISSN: 1660-4601
CID: 4590272

Managing Hyperkalemia: Another Benefit of Exercise in People With Chronic Kidney Disease?

St-Jules, David E; Marinaro, Meredith; Goldfarb, David S; Byham-Gray, Laura D; Wilund, Kenneth R
People with chronic kidney disease (CKD) are at increased risk of hyperkalemia, an electrolyte abnormality that can cause serious, sometimes fatal, cardiac arrhythmias. Muscle contraction causes potassium to be released from cells, increasing serum potassium concentrations. However, these effects are transient, and the long-term impact of exercise training on hyperkalemia risk in CKD patients is largely unknown. In this review, we examine the effects of exercise on factors affecting potassium balance in people with CKD, highlighting the potential benefits of regular exercise on hyperkalemia risk in this population. Although regular exercise is already recommended for people with CKD, research examining this hypothesis may lead to novel therapeutic treatments for this life-threatening condition.
PMID: 31767517
ISSN: 1532-8503
CID: 4215702

Evaluating steady-state resting energy expenditure using indirect calorimetry in adults with overweight and obesity

Popp, C J; Butler, M; Curran, M; Illiano, P; Sevick, M A; St-Jules, D E
BACKGROUND:Determining a period of steady state (SS) is recommended when estimating resting energy expenditure (REE) using a metabolic cart. However, this practice may be unnecessarily burdensome and time-consuming in the research setting. AIM/OBJECTIVE:The aim of the study was to evaluate the use of SS criteria, and compare it to alternative approaches in adults with overweight and obesity. METHODS:) using repeated measures ANOVA and Bland-Altman analysis to test for bias, limits of agreement and accuracy (±6% measured REE). RESULTS:, in particular, outperforming standard prediction equations (e.g., Mifflin St. Joer). CONCLUSION/CONCLUSIONS:Indirect calorimetry measurements that utilize the 5-min SS approach to estimate REE are considered the gold-standard. Under circumstances of non-SS, it appears 4-min and 3-min SS periods, or fixed time intervals of atleast 5 min are accurate and practical alternatives for estimating REE in adults with overweight and obesity. However, future trials should validate alternative methods in similar populations to confirm these findings.
PMID: 31669004
ISSN: 1532-1983
CID: 4542502

Assessing the Protective Metabolome Using Machine Learning in World Trade Center Particulate Exposed Firefighters at Risk for Lung Injury

Crowley, George; Kwon, Sophia; Ostrofsky, Dean F; Clementi, Emily A; Haider, Syed Hissam; Caraher, Erin J; Lam, Rachel; St-Jules, David E; Liu, Mengling; Prezant, David J; Nolan, Anna
The metabolome of World Trade Center (WTC) particulate matter (PM) exposure has yet to be fully defined and may yield information that will further define bioactive pathways relevant to lung injury. A subset of Fire Department of New York firefighters demonstrated resistance to subsequent loss of lung function. We intend to characterize the metabolome of never smoking WTC-exposed firefighters, stratified by resistance to WTC-Lung Injury (WTC-LI) to determine metabolite pathways significant in subjects resistant to the loss of lung function. The global serum metabolome was determined in those resistant to WTC-LI and controls (n = 15 in each). Metabolites most important to class separation (top 5% by Random Forest (RF) of 594 qualified metabolites) included elevated amino acid and long-chain fatty acid metabolites, and reduced hexose monophosphate shunt metabolites in the resistant cohort. RF using the refined metabolic profile was able to classify cases and controls with an estimated success rate of 93.3%, and performed similarly upon cross-validation. Agglomerative hierarchical clustering identified potential influential pathways of resistance to the development of WTC-LI. These pathways represent potential therapeutic targets and warrant further research.
PMID: 31481674
ISSN: 2045-2322
CID: 4069072

Determinants and the Role of Self-Efficacy in a Sodium-Reduction Trial in Hemodialysis Patients

Hu, Lu; St-Jules, David E; Popp, Collin J; Sevick, Mary Ann
OBJECTIVE:This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy. METHODS:This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy. RESULTS:The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD. CONCLUSION/CONCLUSIONS:The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.
PMID: 30579673
ISSN: 1532-8503
CID: 3560282