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The PERSonalized Glucose Optimization Through Nutritional Intervention (PERSON) Study: Rationale, Design and Preliminary Screening Results.

ABSTRACT: Background: It is well-established that the etiology of type 2 diabetes differs between individuals. Insulin resistance (IR) may develop in different tissues, but the severity of IR may differ in key metabolic organs such as the liver and skeletal muscle. Recent evidence suggests that these distinct tissue-specific IR phenotypes may also respond differentially to dietary macronutrient composition with respect to improvements in glucose metabolism. Objective: The main objective of the PERSON study is to investigate the effects of an optimal vs. suboptimal dietary macronutrient intervention according to tissue-specific IR phenotype on glucose metabolism and other health outcomes. Methods: In total, 240 overweight/obese (BMI 25 - 40 kg/m²) men and women (age 40 - 75 years) with either skeletal muscle insulin resistance (MIR) or liver insulin resistance (LIR) will participate in a two-center, randomized, double-blind, parallel, 12-week dietary intervention study. At screening, participants undergo a 7-point oral glucose tolerance test (OGTT) to determine the hepatic insulin resistance index (HIRI) and muscle insulin sensitivity index (MISI), classifying each participant as either "No MIR/LIR," "MIR," "LIR," or "combined MIR/LIR." Individuals with MIR or LIR are randomized to follow one of two isocaloric diets varying in macronutrient content and quality, that is hypothesized to be either an optimal or suboptimal diet, depending on their tissue-specific IR phenotype (MIR/LIR). Extensive measurements in a controlled laboratory setting as well as phenotyping in daily life are performed before and after the intervention. The primary study outcome is the difference in change in disposition index, which is the product of insulin sensitivity and first-phase insulin secretion, between participants who received their hypothesized optimal or suboptimal diet. Discussion: The PERSON study is one of the first randomized clinical trials in the field of precision nutrition to test effects of a more personalized dietary intervention based on IR phenotype. The results of the PERSON study will contribute knowledge on the effectiveness of targeted nutritional strategies to the emerging field of precision nutrition, and improve our understanding of the complex pathophysiology of whole body and tissue-specific IR. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03708419, clinicaltrials.gov as NCT03708419.

SUBMITTER: Gijbels A

PROVIDER: S-EPMC8278004 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionAn elevated postprandial glucose response is associated with an increased risk of cardiometabolic diseases. Existing research suggests large heterogeneity in the postprandial glucose responses to identical meals and food products between individuals, but the effect of other consumed meals during the day and the order of meals during the day on the heterogeneity in postprandial glucose responses still needs to be investigated. In addition, the robustness of the glucose responses to meals or foods is still unknown.ObjectivesThe overall aim of the project is to assess whether the glucose response to a meal is sufficiently person-specific to use in personalized dietary advice. We aim to answer the question: "How replicable are glucose responses to meals within individuals and how consistent is the variation in glucose responses between individuals?"MethodsThe question will be assessed under standardized conditions of a 9-week fully controlled dietary intervention in which all meals are the same between individuals and consumed in a fixed order at a fixed time. 63 apparently healthy men and women with a BMI of 25-40 kg/m2 and aged 45-75 years were enrolled in the RepEAT study (NCT05456815), of whom 53 participants completed the study. The RepEAT study comprised a fully controlled dietary intervention of nine weeks, consisting of three repetitive periods of three weeks. Within each three-week period, a variety of meals and food products were offered during breakfast, lunch, dinner and in between meal snacks. Throughout the dietary intervention, glucose was continuously monitored using Freestyle Libre Pro IQ monitors. Physical activity was monitored using the ActiGraph and ActivPAL. To measure the association between glucose responses and an individual's phenotype, various measurements were performed before the start of the dietary intervention including an oral glucose tolerance test, a high-fat mixed meal challenge, assessment of body fat distribution including liver fat (MRI/MRS), and cardiometabolic markers.DiscussionThe repetitive and fully controlled nature of the dietary study allows detailed assessment of the replicability of the glucose responses to meals and food products within individuals. Furthermore, the consistency of the variation between individuals independent of insulin resistance will be determined.

Project description:BackgroundPositive psychological constructs, such as optimism, are associated with greater participation in cardiac health behaviors and improved cardiac outcomes. Positive psychology interventions, which target psychological well-being, may represent a promising approach to improving health behaviors in high-risk cardiac patients. However, no study has assessed whether a positive psychology intervention can promote physical activity following an acute coronary syndrome.ObjectiveIn this article we will describe the methods of a novel factorial design study to aid the development of a positive psychology-based intervention for acute coronary syndrome patients and aim to provide preliminary feasibility data on study implementation.MethodsThe Positive Emotions after Acute Coronary Events III study is an optimization study (planned N = 128), subsumed within a larger multiphase optimization strategy iterative treatment development project. The goal of Positive Emotions after Acute Coronary Events III is to identify the ideal components of a positive psychology-based intervention to improve post-acute coronary syndrome physical activity. Using a 2 × 2 × 2 factorial design, Positive Emotions after Acute Coronary Events III aims to: (1) evaluate the relative merits of using positive psychology exercises alone or combined with motivational interviewing, (2) assess whether weekly or daily positive psychology exercise completion is optimal, and (3) determine the utility of booster sessions. The study's primary outcome measure is moderate-to-vigorous physical activity at 16 weeks, measured via accelerometer. Secondary outcome measures include psychological, functional, and adherence-related behavioral outcomes, along with metrics of feasibility and acceptability. For the primary study outcome, we will use a mixed-effects model with a random intercept (to account for repeated measures) to assess the main effects of each component (inclusion of motivational interviewing in the exercises, duration of the intervention, and inclusion of booster sessions) from a full factorial model controlling for baseline activity. Similar analyses will be performed on self-report measures and objectively-measured medication adherence over 16 weeks. We hypothesize that the combined positive psychology and motivational interviewing intervention, weekly exercises, and booster sessions will be associated with superior physical activity.ResultsThus far, 78 participants have enrolled, with 72% of all possible exercises fully completed by participants.ConclusionThe Positive Emotions after Acute Coronary Events III study will help to determine the optimal content, intensity, and duration of a positive psychology intervention in post-acute coronary syndrome patients prior to testing in a randomized trial. This study is novel in its use of a factorial design within the multiphase optimization strategy framework to optimize a behavioral intervention and the use of a positive psychology intervention to promote physical activity in high-risk cardiac patients.

Project description:We describe the study design and methods used in a 9-month pedometer-based worksite intervention called "ASUKI Step" conducted at the Karolinska Institutet (KI) in Stockholm, Sweden and Arizona State University (ASU) in the greater Phoenix area, Arizona."ASUKI Step" was based on the theory of social support and a quasi-experimental design was used for evaluation. Participants included 2,118 faculty, staff, and graduate students from ASU (n = 712) and KI (n = 1,406) who participated in teams of 3-4 persons. The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week. Study aims were: 1) to have a minimum of 400 employee participants from each university site reach a level of 10,000 steps per day on at least 100 days (3.5 months) during the trial period; 2) to have 70% of the employee participants from each university site maintain two or fewer inactive days per week, defined as a level of less than 3,000 steps per day; 3) to describe the socio-demographic, psychosocial, environmental and health-related determinants of success in the intervention; and 4) to evaluate the effects of a pedometer-based walking intervention in a university setting on changes in self-perceived health and stress level, sleep patterns, anthropometric measures and fitness.Incentives were given for compliance to the study protocol that included weekly raffles for participation prizes and a grand finale trip to Arizona or Sweden for teams with most days over 10,000 steps."ASUKI Step" is designed to increase the number of days employees walk 10,000 steps and to reduce the number of days employees spend being inactive. The study also evaluates the intra- and interpersonal determinants for success in the intervention and in a sub-sample of the study, changes in physical fitness and body composition during the study.Current Controlled Trials NCT01537939.

Project description:BACKGROUND:Transfer from pediatric to adult care is a crucial period for adolescents with inflammatory bowel disease (IBD). OBJECTIVE:Our aim was to develop a personalized transition-transfer concept including relevant tools in an established eHealth (electronic health) program. METHODS:Required transition skills and validated patient-reported outcome measures (PROMs) were identified via bibliographic search and clinical experience and were implemented into an existing eHealth program. RESULTS:The following skills were identified: disease knowledge, social life, disease management, and making well-informed, health-related decisions. The PROMs included the following: self-efficacy (the IBD Self-Efficacy Scale-Adolescents), resilience (the 10-item Connor-Davidson Resilience Scale), response to stress (the Child Self-Report Responses to Stress-IBD), and self-management and health care transition skills (the Self-Management and Transition to Adulthood with Treatment questionnaire). Starting at age 14, the patient will be offered a 1-hour annual transition consultation with an IBD-specialized nurse. The consultation will be based on the results of the PROMs and will focus on the patient's difficulties. Patients will complete the PROMs on the eHealth program at home, allowing nurses and patients to prepare for the meeting. Symptom scores and medication will be filled out on the eHealth program to support disease self-management. The consultation will be a topic-centered dialogue with practical exercises. During routine outpatient visits with the provider, parents will be left out of half of the consultation when the patient is 16 years old; at 17 years old, the parents will not be present. At the transfer consultation, the pediatric provider, the adult gastroenterologist, the pediatric nurse, the patient, and the parents will be present to ensure a proper transfer. CONCLUSIONS:We have conducted a personalized eHealth transition concept consisting of basic elements that measure, train, and monitor the patients' transition readiness. The concept can be implemented and adjusted to local conditions.

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The PERSonalized Glucose Optimization Through Nutritional Intervention (PERSON) Study: Rationale, Design and Preliminary Screening Results.

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