The role of nutrition-related clinical trials in informing dietary recommendations for health and treatment of diseases.

Dietary guidance is based on a robust evidence base that includes high-quality clinical trials, of which some have been designed to establish causal relationships between dietary interventions and ASCVD risk reduction. However, the complexity associated with conducting these trials has resulted in criticism of nutrition and dietary recommendations because the strength and quality of evidence falls short of that for some pharmaceutical interventions. In this paper, we aim to promote greater awareness of the nutrition-related clinical trials that have been conducted showing ASCVD benefits and how this evidence has contributed to dietary recommendations.

Isocaloric replacement of ultraprocessed foods was associated with greater weight loss in the POUNDS Lost trial.

Objective: Higher intake of ultraprocessed foods (UPFs) is associated with obesity. We examined whether replacing UPFs (NOVA 4) with minimally processed foods and culinary ingredients (NOVA 1 + 2) was associated with differential weight change in this secondary prospective analysis of the Preventing Overweight Using Novel Dietary Strategies (POUNDS) Lost trial.

Methods: We estimated percent energy intake (%kcal) from the four NOVA groups using 24-h dietary recalls in a subset of 356 participants.

Adolescent Diet Quality, Cardiometabolic Risk, and Adiposity: A Prospective Cohort.

Objective: Examine the prospective association among diet with adolescent cardiometabolic risk (CMR) and anthropometrics.

Methods: Secondary analysis of an observational study of adolescents aged 10-16 years. Twenty-four-hour food recalls were used to calculate Healthy Eating Index-2015 (HEI-2015) scores.

The Personalized Nutrition Study (POINTS): evaluation of a genetically informed weight loss approach, a Randomized Clinical Trial.

Weight loss (WL) differences between isocaloric high-carbohydrate and high-fat diets are generally small; however, individual WL varies within diet groups. Genotype patterns may modify diet effects, with carbohydrate-responsive genotypes losing more weight on high-carbohydrate diets (and vice versa for fat-responsive genotypes). We investigated whether 12-week WL (kg, primary outcome) differs between genotype-concordant and genotype-discordant diets.

DNA Methylation Near CPT1A and Changes in Triglyceride-rich Lipoproteins in Response to Weight-loss Diet Interventions.

Context: Carnitine palmitoyltransferase-1A, encoded by the CPT1A gene, plays a key role in the oxidation of long-chain fatty acids in the mitochondria and may be important in triglyceride metabolism. Previous work has shown that high fat intake was negatively associated with CPT1A methylation and positively associated with CPT1A expression.

Objective: We aim to investigate the association of DNA methylation (DNAm) at the CPT1A gene with reductions in triglycerides and triglyceride-rich lipoproteins (TRLs) in response to weight-loss diet interventions.

Genetically determined gut microbial abundance and 2-year changes in central adiposity and body composition: The POUNDS lost trial.

Background And Aim: Growing evidence has linked gut microbiota with regulation of adiposity. We aimed to examine whether the genetically determined relative abundance of gut microbial taxa was associated with long-term changes in adiposity and body composition among individuals who were overweight or obese in weight-loss diet interventions.

Methods: The study included 692 participants with overweight or obese from the POUNDS Lost trial.

Association between Sleep, Sedentary Time, Physical Activity, and Adiposity in Adolescents: A Prospective Observational Study.

Purpose: This study aimed to examine the effects of substituting sedentary time with sleep or physical activity on adiposity in a longitudinal sample of adolescents.

Methods: Adolescents (10-16 yr) were recruited for a prospective observational cohort. Parents and adolescents reported demographic characteristics and pubertal development.

Nutritional quality of calorie restricted diets in the CALERIE™ 1 trial.

Objectives: The aim was to determine the nutritional adequacy of calorie restricted (CR) diets during CR interventions up to 12 months.

Methods: The Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE™) phase 1 trial consisted of 3 single-site studies to test the feasibility and effectiveness of CR in adults without obesity. After baseline assessments, participants who were randomized to a CR intervention received education and training from registered dietitians on how to follow a healthful CR diet.

A Food-Based Intervention in a Military Dining Facility Improves Blood Fatty Acid Profile.

Enhancing dietary omega-3 highly unsaturated fatty acids (n-3 HUFA) intake may confer neuroprotection, brain resiliency, improve wound healing and promote cardiovascular health. This study determined the efficacy of substituting a few common foods (chicken meat, chicken sausage, eggs, salad dressings, pasta sauces, cooking oil, mayonnaise, and peanut butter) lower in omega-6 polyunsaturated fatty acids (n-6 PUFA) and higher in n-3 HUFA in a dining facility on blood fatty acid profile. An eight-week prospective, between-subjects ( = 77), repeated measures, parallel-arm trial was conducted.

DREAM-ICD-II Study.

Background: Regulatory authorities of most industrialized countries recommend 6 months of private driving restriction after implantation of a secondary prevention implantable cardioverter-defibrillator (ICD). These driving restrictions result in significant inconvenience and social implications. This study aimed to assess the incidence rate of appropriate device therapies in contemporary recipients of a secondary prevention ICD.

Percutaneous left atrial appendage closure in patients with primary hemostasis disorders and atrial fibrillation.

Background Or Purpose: We report our single-center experience with percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) and primary hemostasis disorders (HD).

Methods: Consecutive patients with primary HD who underwent a percutaneous LAAC were included. Baseline characteristics, procedural data, and clinical outcomes were prospectively collected and compared with the overall LAAC cohort without HD.

Left atrial appendage perforation during appendage angiography treated by percutaneous left atrial appendage closure: a case report.

Background: Pericardial effusion is a common complication of percutaneous left atrial appendage (LAA) closure. Acute management is the cornerstone of pericardial effusion treatment and interrupting the intervention is often required.

Case Summary: A 65-year-old man presented an acute 10 mm pericardial effusion following pigtail contrast appendage injection.

Resting Energy Expenditure Is Elevated in Asthma.

Asthma physiology affects respiratory function and inflammation, factors that may contribute to elevated resting energy expenditure (REE) and altered body composition. We hypothesized that asthma would present with elevated REE compared to weight-matched healthy controls. Adults with asthma ( = 41) and healthy controls ( = 20) underwent indirect calorimetry to measure REE, dual-energy X-ray absorptiometry (DEXA) to measure body composition, and 3-day diet records.

Twiddler Syndrome without Lead Dislodgment Discovered by Remote Monitoring.

Twiddler syndrome is an uncommon yet dangerous phenomenon usually resulting in lead displacement with loss of capture of cardiac implantable electronic devices. In this case report, we present an interesting case of Twiddler syndrome without lead dislodgment which was detected by an alert triggered by an increase in impedance on remote monitoring.

Integrative and quantitative bioenergetics: Design of a study to assess the impact of the gut microbiome on host energy balance.

Unlabelled: The literature is replete with clinical studies that characterize the structure, diversity, and function of the gut microbiome and correlate the results to different disease states, including obesity. Whether the microbiome has a direct impact on obesity has not been established. To address this gap, we asked whether the gut microbiome and its bioenergetics quantitatively change host energy balance.

Genetic variation in lean body mass, changes of appetite and weight loss in response to diet interventions: The POUNDS Lost trial.

Aim: To investigate whether the genetic risk score (GRS) for lean body mass (LBM) modified the effects of weight-loss diets on changes in appetite and adiposity among overweight and obese individuals.

Participants And Methods: In the 2-year Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) trial, we included 692 adults who were randomly assigned to one of four diets varying in macronutrient intake. A GRS was calculated using five single nucleotide polymorphisms associated with LBM.

The Type and Amount of Dietary Fat Affect Plasma Factor VIIc, Fibrinogen, and PAI-1 in Healthy Individuals and Individuals at High Cardiovascular Disease Risk: 2 Randomized Controlled Trials.

Background: Factor VIIc, fibrinogen, and plasminogen activator inhibitor 1 (PAI-1) are cardiovascular disease (CVD) risk factors and are modulated, in part, by fat type and amount.

Objective: We evaluated fat type and amount on the primary outcomes: factor VIIc, fibrinogen, and PAI-1.

Methods: In the Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA) Trial, 2 controlled crossover feeding studies evaluated substituting carbohydrate or MUFAs for SFAs.

Association Between Meeting Physical Activity, Sleep, and Dietary Guidelines and Cardiometabolic Risk Factors and Adiposity in Adolescents.

Purpose: The aim of the study was to assess the associations of meeting physical activity (PA), sleep, and dietary guidelines with cardiometabolic risk factors and adiposity in adolescents.

Methods: The sample included adolescents aged 10-16 years. Accelerometry was used to measure PA and sleep over 7 days, 24 h/d.

Predicting Weight Loss Using Psychological and Behavioral Factors: The POUNDS LOST Trial.

Context: Eating habits and food craving are strongly correlated with weight status. It is currently not well understood how psychological and behavioral factors influence both weight loss and weight regain.

Objective: To examine the associations between psychological and behavioral predictors with weight changes and energy intake in a randomized controlled trial on weight loss.

Associations of Sleep with Food Cravings, Diet, and Obesity in Adolescence.

: Sleep and dietary intake/quality can contribute to excess weight gain, but food cravings may influence these relationships. This cross-sectional study examined the relationship of adolescents' sleep characteristics with dietary intake/quality and obesity and whether food cravings mediated these relationships. : Sleep measures were calculated based on 24-h accelerometry, and height and weight were directly measured to calculate body mass index (BMI) z-scores.

Racial differences in body composition and cardiometabolic risk during the menopause transition: a prospective, observational cohort study.

Background: Obesity disproportionately affects more women than men. The loss of ovarian function during the menopause transition coincides with weight gain, increases in abdominal adiposity, and impaired metabolic health. Racial differences in obesity prevalence that results from the menopause transition are not well understood.

Fiber Intake Predicts Weight Loss and Dietary Adherence in Adults Consuming Calorie-Restricted Diets: The POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study.

Background: The effects of dietary composition on weight loss are incompletely understood. In addition to energy intake, fiber intake, energy density, macronutrient composition, and demographic characteristics have all been suggested to contribute to weight loss.

Objective: The primary aim of this analysis was to assess the role of dietary fiber as a predictor of weight loss in participants who consumed calorie-restricted diets (-750 kcal/d from estimated energy needs) for 6 mo, using data from the POUNDS Lost (Preventing Overweight Using Novel Dietary Strategies) Study-a randomized trial that examined the effects of calorie-restricted diets varying in macronutrient composition on weight loss in adults.

The Percentage of Dietary Phosphorus Excreted in the Urine Varies by Dietary Pattern in a Randomized Feeding Study in Adults.

Background: Urinary phosphorus excretion has been proposed as a recovery biomarker of dietary phosphorus intake. However, it is unclear whether phosphorus excretion is constant across a range of dietary and nondietary factors.

Objective: We assessed whether percentage urinary phosphorus excretion is constant across 3 dietary patterns in the Dietary Approaches to Stop Hypertension (DASH) trial.