Low- vs high-glycemic index Mediterranean-style eating patterns improved some domains of health-related quality of life but not sleep in adults at risk for type 2 diabetes: The MEDGICarb randomized controlled trial.

BACKGROUND: A healthy eating pattern such as the Mediterranean-style (MED-HEP) is associated with favorable effects on both cardiometabolic risk markers and self-reported health outcomes. Limited evidence exists regarding the influence of glycemic index (GI) of carbohydrate foods consumed within a healthy eating pattern on self-reported health-status and sleep. OBJECTIVE: To investigate the effects of a low- vs high-GI MED-HEP on changes in health-related quality of life (HRQoL) and sleep. METHODS: The MedGICarb-intervention trial is a 12-week randomized, controlled, parallel multi-center-trial in adults with at least two features of the metabolic syndrome. Participants consumed an eu-energetic diet profiled as a MED-HEP with either low GI (experimental) or high GI (control). HRQoL and sleep were measured with Medical Outcomes Study 36-Item Short Form Health Survey Version 2 (SF-36v2), Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) at baseline and post-intervention. RESULTS: 160 adults with ≥ 2 features of the metabolic syndrome completed the intervention (53 % females, age 56 ± 10 y, BMI 31.0 ± 3.1 kg/m2). Low- vs high-GI MED-HEP resulted in differential changes between the groups in the HRQoL domains role physical (5.6 ± 2.2 AU vs -2.5 ± 2.5 AU) and vitality (6.9 ± 1.7 AU vs 0.0 ± 1.8 AU) (p < 0.05), which were driven mostly by improvements in the low-GI group. There were no significant differences between the MED-HEPs for changes in aggregated physical or mental components or for the other individual domains of HRQoL (physical functioning, bodily pain, general health, social functioning, role emotional and mental health) or for sleep quality or daytime sleepiness. CONCLUSIONS: Low compared to high GI in the context of a MED-HEP resulted in modest improvements in some, but not all, health domains of HRQoL. No major differences were seen between the groups for measures of sleep. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The trial is registered in the public trial database Clinicaltrials.gov as NCT03410719, https://clinicaltrials.gov/study/NCT03410719?term=NCT03410719&rank=1.

Consuming Mushrooms When Adopting a Healthy Mediterranean-Style Dietary Pattern Does Not Influence Short-Term Changes of Most Cardiometabolic Disease Risk Factors in Healthy Middle-Aged and Older Adults.

BACKGROUND: Mushrooms are a nutritious food, though knowledge of the effects of mushroom consumption on cardiometabolic risk factors is limited and inconsistent. OBJECTIVE: We assessed the effects of consuming mushrooms as part of a healthy United States Mediterranean-style dietary pattern (MED) on traditional and emerging cardiometabolic disease (CMD) risk factors. We hypothesized that adopting a MED diet with mushrooms would lead to greater improvements in multiple CMD risk factors. METHODS: Using a randomized, parallel study design, 60 adults (36 females, 24 males; aged 46 ± 12 y; body mass index 28.3 ± 2.84 kg/m2, mean ± standard deviation) without diagnosed CMD morbidities consumed a MED diet (all foods provided) without (control with breadcrumbs) or with 84 g/d of Agaricus bisporus (White Button, 4 d/wk) and Pleurotus ostreatus (Oyster, 3 d/wk) mushrooms for 8 wk. Fasting baseline and postintervention outcome measurements were traditional CMD risk factors, including blood pressure and fasting serum lipids, lipoproteins, glucose, and insulin. Exploratory CMD-related outcomes included lipoprotein particle sizes and indexes of inflammation. RESULTS: Adopting the MED-mushroom diet compared with the MED-control diet without mushrooms improved fasting serum glucose (change from baseline -2.9 ± 1.18 compared with 0.6 ± 1.10 mg/dL; time × group P = 0.034). Adopting the MED diet, independent of mushroom consumption, reduced serum total cholesterol (-10.2 ± 3.77 mg/dL; time P = 0.0001). Concomitantly, there was a reduction in high-density lipoprotein (HDL) cholesterol, buoyant HDL2b, and apolipoprotein A1, and an increase in lipoprotein(a) concentrations (main effect of time P < 0.05 for all). There were no changes in other measured CMD risk factors. CONCLUSIONS: Consuming a Mediterranean-style healthy dietary pattern with 1 serving/d of whole Agaricus bisporus and Pleurotus ostreatus mushrooms improved fasting serum glucose but did not influence other established or emerging CMD risk factors among middle-aged and older adults classified as overweight or obese but with clinically normal cardiometabolic health. TRIAL REGISTRATION NUMBER: https://www. CLINICALTRIALS: gov/study/NCT04259229?term=NCT04259229&rank=1.

Salmon Food-Specific Compounds and Their Metabolites Increase in Human Plasma and Are Associated with Cardiometabolic Health Indicators Following a Mediterranean-Style Diet Intervention.

BACKGROUND: Nutrimetabolomics allows for the comprehensive analysis of foods and human biospecimens to identify biomarkers of intake and begin to probe their associations with health. Salmon contains hundreds of compounds that may provide cardiometabolic benefits. OBJECTIVES: We used untargeted metabolomics to identify salmon food-specific compounds (FSCs) and their predicted metabolites that were found in plasma after a salmon-containing Mediterranean-style (MED) diet intervention. Associations between changes in salmon FSCs and changes in cardiometabolic health indicators (CHIs) were also explored. METHODS: For this secondary analysis of a randomized, crossover, controlled feeding trial, 41 participants consumed MED diets with 2 servings of salmon per week for 2 5-wk periods. CHIs were assessed, and fasting plasma was collected pre- and postintervention. Plasma, salmon, and 99 MED foods were analyzed using liquid chromatography-mass spectrometry-based metabolomics. Compounds were characterized as salmon FSCs if detected in all salmon replicates but none of the other foods. Metabolites of salmon FSCs were predicted using machine learning. For salmon FSCs and metabolites found in plasma, linear mixed-effect models were used to assess change from pre- to postintervention and associations with changes in CHIs. RESULTS: Relative to the other 99 MED foods, there were 508 salmon FSCs with 237 unique metabolites. A total of 143 salmon FSCs and 106 metabolites were detected in plasma. Forty-eight salmon FSCs and 30 metabolites increased after the intervention (false discovery rate <0.05). Increases in 2 annotated salmon FSCs and 2 metabolites were associated with improvements in CHIs, including total cholesterol, low-density lipoprotein cholesterol, triglycerides, and apolipoprotein B. CONCLUSIONS: A data-driven nutrimetabolomics strategy identified salmon FSCs and their predicted metabolites that were detectable in plasma and changed after consumption of a salmon-containing MED diet. Findings support this approach for the discovery of compounds in foods that may serve, upon further validation, as biomarkers or act as bioactive components influential to health. The trials supporting this work were registered at NCT02573129 (Mediterranean-style diet intervention) and NCT05500976 (ongoing clinical trial).

Greater Protein Intake Emphasizing Lean Beef Does Not Affect Resistance Training-Induced Adaptations in Skeletal Muscle and Tendon of Older Women: A Randomized Controlled Feeding Trial.

BACKGROUND: Although experimental research supports that resistance training (RT), especially with greater dietary protein intake, improves muscle mass and strength in older adults, comparable research on tendons is needed. OBJECTIVES: We assessed the effects of a protein-rich diet emphasizing lean beef, compared with 2 control diets, on RT-induced changes in skeletal muscle and tendon size and strength in older women. METHODS: We randomly assigned women [age: 66 ± 1 y, body mass index (BMI): 28 ± 1] to groups that consumed 1) 0.8 g total protein/kg body weight/day from mixed food sources (normal protein control, n = 16); 2) 1.4 g/kg/d protein from mixed food sources (high protein control, n = 17); or 3) 1.4 g/kg/d protein emphasizing unprocessed lean beef (high protein experimental group, n = 16). Participants were provided with all foods and performed RT 3 times/wk, 70% of 1-repetition maximum for 12 wk. We measured quadriceps muscle volume via magnetic resonance imaging (MRI). We estimated patellar tendon biomechanical properties and cross-sectional area (CSA) using ultrasound and MRI. RESULTS: Dietary intake did not influence RT-induced increases in quadriceps strength (P < 0.0001) or muscle volume (P < 0.05). We noted a trend for an RT effect on mean tendon CSA (P = 0.07), with no differences among diets (P > 0.05). Proximal tendon CSA increased with RT (P < 0.05) with no difference between dietary groups (P > 0.05). Among all participants, midtendon CSA increased with RT (P ≤ 0.05). We found a decrease in distal CSA in the 0.8 g group (P < 0.05) but no change in the 1.4 g group (P > 0.05). Patellar tendon MRI signal or biomechanical properties were unchanged. CONCLUSIONS: Our findings indicated that greater daily protein intake, emphasizing beef, did not influence RT-induced changes in quadriceps muscle strength or muscle volume of older women. Although we noted trends in tendon CSA, we did not find a statistically significant impact of greater daily protein intake from beef on tendon outcomes. This trial was registered at clinicaltrials.gov as NCT04347447.

Important Concepts in Protein Nutrition, Aging, and Skeletal Muscle: Honoring Dr Douglas Paddon-Jones (1969-2021) by Highlighting His Research Contributions.

This review is a tribute to honor Dr Douglas Paddon-Jones by highlighting his career research contributions. Dr Paddon-Jones was a leader in recognizing the importance of muscle health and the interactions of physical activity and dietary protein for optimizing the health span. Aging is characterized by loss of muscle mass and strength associated with reduced rates of muscle protein synthesis (MPS) and the ability to repair and replace muscle proteins. Research from the team at the University of Texas Medical Branch in Galveston discovered that the age-related decline in MPS could be overcome by increasing the quantity or quality of dietary protein at each meal. Dr Paddon-Jones was instrumental in proposing and testing a "protein threshold" of ∼30 g protein/meal to optimize MPS in older adults. Dr Paddon-Jones demonstrated that physical inactivity greatly accelerates the loss of muscle mass and function in older adults. His work in physical activity led him to propose the "Catabolic Crisis Model" of muscle size and function losses, suggesting that age-related muscle loss is not a linear process, but the result of acute periods of disuse associated with injuries, illnesses, and bed rest. This model creates the opportunity to provide targeted interventions via protein supplementation and/or increased dietary protein through consuming high-quality animal-source foods. He illustrated that nutritional support, particularly enhanced protein quantity, quality, and meal distribution, can help preserve muscle health during periods of inactivity and promote health across the life course.

Effects of Adding Lean Red Meat to a U.S.-Style Healthy Vegetarian Dietary Pattern on Gut Microbiota and Cardiovascular Risk Factors in Young Adults: a Crossover Randomized Controlled Trial.

BACKGROUND: Limited research evidence exists on the effects of red meat on gut microbiota in human adults. OBJECTIVE: We aim to assess the effects of consuming a Healthy U.S.-Style Dietary Pattern (HDP), without or with unprocessed or processed lean red meats, on gut microbiota and fecal short-chain fatty acid (SCFA) levels in healthy young adults. Secondary outcomes are cardiovascular disease risk factors. METHODS: We conducted a randomized, controlled, crossover trial with 3 3-wk dietary interventions, each separated by a 5-wk washout period with habitual dietary intake. Nineteen participants (8 females, age 26 ± 4 y old, BMI 23 ± 3 kg/m2) consumed 3 study diets in random order: 1) healthy lacto-ovo vegetarian diet (LOV); 2) LOV plus 3 ounces/d of cooked unprocessed lean red meat (URM); and 3) LOV plus 3 ounces/d of cooked processed lean red meat (PRM). Fecal and fasting blood samples were collected before and during the last 2 wk of each intervention. We measured fecal bacterial community structure using 16S rRNA amplicon sequencing (V4 region, primers 515F-806R). Community diversity, structure, and taxonomic composition were computed using Mothur v.1.44.3. RESULTS: The addition of unprocessed or processed lean red meats to a LOV HDP did not influence short-term changes in bacterial taxonomic composition. Independent of red meat intake, the HDP led to changes in 23 bacteria; reductions in serum total cholesterol (TC) and LDL-C concentrations; but no changes in fecal SCFA, serum triglycerides, HDL-C concentrations, TC/HDL-C ratio, or blood pressures. With data from all 3 diet interventions combined, changes in some bacteria were associated with improvements in TC, LDL-C, triglycerides, and HDL-C concentrations, and TC/HDL-C ratio. CONCLUSIONS: Healthy young adults who adopt an HDP that may be vegetarian or omnivorous, including lean red meat, experience short-term changes in gut microbial composition, which associate with improvements in multiple lipid-related cardiovascular risk factors. NCT03885544, https://clinicaltrials.gov/ct2/show/NCT03885544?cond=NCT03885544&draw=2&rank=1.

Plant- and Animal-Based Protein-Rich Foods and Cardiovascular Health.

PURPOSE OF REVIEW: To summarize recent evidence from randomized controlled feeding trials (RCTs) on the effects of consuming plant- and animal-based protein-rich foods on cardiovascular health of adults. RECENT FINDINGS: Results from meta-analyses of RCTs exemplify the importance of considering relative effects of protein-rich foods, i.e., when intake of one food increases, intake of another food likely decreases. Results from short-term RCTs showed that overall diet quality is more influential for improving cardiovascular disease (CVD) risk factors than intake of a single protein-rich food, e.g., red meat. Yet, assessing long-term CVD risk associated with intake of a single protein-rich food as part of a dietary pattern is methodologically challenging. While accumulating evidence suggests gut microbiota as a potential mediator for such effects, current knowledge is preliminary and restricts causal or functional inferences. A variety of protein-rich foods, both plant- and animal-based, should be consumed as part of nutrient-dense dietary patterns to meet nutrient needs and improve cardiovascular health for adults.

Red and processed meat intakes and cardiovascular disease and type 2 diabetes mellitus: An umbrella systematic review and assessment of causal relations using Bradford Hill's criteria.

Observational research suggests higher red and processed meat intakes predict greater risks of developing or dying from cardiovascular diseases (CVD) and type 2 diabetes mellitus (T2DM), but this research limits causal inference. This systematic review of reviews utilizes both observational and experimental research findings to infer causality of these relations. Reviews from four databases were screened by two researchers. Reviews included unprocessed red meat (URM), processed meat (PM), or mixed URM + PM intake, and reported CVD or T2DM outcomes. Twenty-nine reviews were included, and causality was inferred using Bradford Hill's Criteria. Observational assessments of CVD outcomes and all meat types consistently reported weak associations while, T2DM outcomes and PM and Mixed URM + PM assessments consistently reported strong associations. Experimental assessments of Mixed URM + PM on CVD and T2DM risk factors were predominately not significant which lacked coherence with observational findings. For all meat types and outcomes, temporality and plausible mechanisms were established, but specificity and analogous relationships do not support causality. Evidence was insufficient for URM and T2DM. More experimental research is needed to strengthen these inferences. These results suggest that red and processed meat intakes are not likely causally related to CVD but there is potential for a causal relationship with T2DM.

Dietary Protein Intake Is Positively Associated with Appendicular Lean Mass and Handgrip Strength among Middle-Aged US Adults.

BACKGROUND: Sarcopenia, a progressive loss of skeletal muscle mass and strength, can begin in the 4th decade of life. Protein intake predicts skeletal muscle mass and strength among older adults, but knowledge of similar associations among middle-aged adults is lacking. OBJECTIVES: We aimed to assess associations between protein intake and skeletal muscle mass, characterized by appendicular lean mass adjusted for BMI [in kg/m2 (ALMBMI)], and muscle strength, represented by handgrip strength adjusted for BMI (GSMAXBMI), among middle-aged adults. METHODS: We analyzed cross-sectional data from 1209 men and 1208 women aged 40-59 y in the 2011-2014 NHANES. Protein intake per kilogram actual body weight (BW), assessed by two 24-h recalls, was examined as continuous and categorical parameters [low (

Nitrated meat products are associated with mania in humans and altered behavior and brain gene expression in rats.

Mania is a serious neuropsychiatric condition associated with significant morbidity and mortality. Previous studies have suggested that environmental exposures can contribute to mania pathogenesis. We measured dietary exposures in a cohort of individuals with mania and other psychiatric disorders as well as in control individuals without a psychiatric disorder. We found that a history of eating nitrated dry cured meat but not other meat or fish products was strongly and independently associated with current mania (adjusted odds ratio 3.49, 95% confidence interval (CI) 2.24-5.45, p < 8.97 × 10-8). Lower odds of association were found between eating nitrated dry cured meat and other psychiatric disorders. We further found that the feeding of meat preparations with added nitrate to rats resulted in hyperactivity reminiscent of human mania, alterations in brain pathways that have been implicated in human bipolar disorder, and changes in intestinal microbiota. These findings may lead to new methods for preventing mania and for developing novel therapeutic interventions.

Adopting a Mediterranean-style eating pattern with low, but not moderate, unprocessed, lean red meat intake reduces fasting serum trimethylamine N-oxide (TMAO) in adults who are overweight or obese.

A Mediterranean-style eating pattern (MED-EP) may include moderate red meat intake. However, it is unknown if the pro-atherogenic metabolite trimethylamine N-oxide (TMAO) is affected by the amount of red meat consumed with a MED-EP. The results presented are from a secondary, retrospective objective of an investigator-blinded, randomized, crossover, controlled feeding trial (two 5-wk interventions separated by a 4-wk washout) to determine if a MED-EP with 200g unprocessed lean red meat/wk (MED-CONTROL) reduces circulating TMAO concentrations compared to a MED-EP with 500g unprocessed lean red meat/wk (MED-RED). Participants were 27 women and 12 men (n=39 total) who were either overweight or obese (BMI: 30.5 ± 0.3 kg/m2 mean ± SEM). Serum samples were obtained following an overnight fast both before (pre) and after (post) each intervention. Fasting serum TMAO, choline, carnitine, and betaine concentrations were measured using a targeted Liquid chromatography-mass spectrometry. Data were analyzed to assess if (a) TMAO and related metabolites differed by intervention, and (b) if changes in TMAO were associated with changes in Framingham 10-year risk score. Serum TMAO was lower post-intervention following MED-CONTROL compared to MED-RED intervention (post-MED-CONTROL 3.1 ± 0.2 µM vs. post-MED-RED 5.0 ± 0.5 µM, p<0.001), and decreased following MED-CONTROL (pre- vs post-MED-CONTROL, p = 0.025). Exploratory analysis using mixed model analysis of covariance identified a positive association between changes in TMAO and changes in HOMA-IR (p = 0.036). These results suggest that lower amounts of red meat intake leads to lower TMAO concentrations in the context of a MED-EP.

Meta-Analysis of Randomized Controlled Trials of Red Meat Consumption in Comparison With Various Comparison Diets on Cardiovascular Risk Factors.

BACKGROUND: Findings among randomized controlled trials evaluating the effect of red meat on cardiovascular disease risk factors are inconsistent. We provide an updated meta-analysis of randomized controlled trials on red meat and cardiovascular risk factors and determine whether the relationship depends on the composition of the comparison diet, hypothesizing that plant sources would be relatively beneficial. METHODS: We conducted a systematic PubMed search of randomized controlled trials published up until July 2017 comparing diets with red meat with diets that replaced red meat with a variety of foods. We stratified comparison diets into high-quality plant protein sources (legumes, soy, nuts); chicken/poultry/fish; fish only; poultry only; mixed animal protein sources (including dairy); carbohydrates (low-quality refined grains and simple sugars, such as white bread, pasta, rice, cookies/biscuits); or usual diet. We performed random-effects meta-analyses comparing differences in changes of blood lipids, apolipoproteins, and blood pressure for all studies combined and stratified by specific comparison diets. RESULTS: Thirty-six studies totaling 1803 participants were included. There were no significant differences between red meat and all comparison diets combined for changes in blood concentrations of total, low-density lipoprotein, or high-density lipoprotein cholesterol, apolipoproteins A1 and B, or blood pressure. Relative to the comparison diets combined, red meat resulted in lesser decreases in triglycerides (weighted mean difference [WMD], 0.065 mmol/L; 95% CI, 0.000-0.129; P for heterogeneity <0.01). When analyzed by specific comparison diets, relative to high-quality plant protein sources, red meat yielded lesser decreases in total cholesterol (WMD, 0.264 mmol/L; 95% CI, 0.144-0.383; P<0.001) and low-density lipoprotein (WMD, 0.198 mmol/L; 95% CI, 0.065-0.330; P=0.003). In comparison with fish, red meat yielded greater decreases in low-density lipoprotein (WMD, -0.173 mmol/L; 95% CI, -0.260 to -0.086; P<0.001) and high-density lipoprotein (WMD, -0.065 mmol/L; 95% CI, -0.109 to -0.020; P=0.004). In comparison with carbohydrates, red meat yielded greater decreases in triglycerides (WMD, -0.181 mmol/L; 95% CI, -0.349 to -0.013). CONCLUSIONS: Inconsistencies regarding the effects of red meat on cardiovascular disease risk factors are attributable, in part, to the composition of the comparison diet. Substituting red meat with high-quality plant protein sources, but not with fish or low-quality carbohydrates, leads to more favorable changes in blood lipids and lipoproteins.

Vitamin D status and supplementation impacts on skeletal muscle function: comparisons between young athletes and older adults.

PURPOSE OF REVIEW: The present narrative review analyzes emerging research implicating vitamin D status and supplementation with skeletal muscle homeostasis and functions in two distinct segments of the adult population: young athletes and older adults. RECENT FINDINGS: Vitamin D deficiency compromises multiple indices of muscle function in young athletes and older adults. A variety of vitamin D3 (cholecalciferol) supplementation regimens may transition young athletes and older adults from deficient or inadequate to adequate vitamin D status. Vitamin D supplementation, used to treat a vitamin D deficiency, but not necessarily an inadequacy, promotes muscle anabolism in older adults. For both young athletes and older adults, vitamin D supplementation, which transitions them from inadequate to adequate vitamin D status, may not beneficially affect measures of muscle strength and power, or physical performance. Also, when vitamin D status is adequate, vitamin D supplementation to further increase serum 25(OH)D concentrations does not seem to confer additional benefits to muscle strength and power and physical performance. SUMMARY: The impacts of vitamin D status and supplementation on skeletal muscle homeostasis and functions seem comparable in young athletes who strive to maximize physical performance and older adults who seek to attenuate muscle mass and physical performance declines.

Adults Who Are Overweight or Obese and Consuming an Energy-Restricted Healthy US-Style Eating Pattern at Either the Recommended or a Higher Protein Quantity Perceive a Shift from "Poor" to "Good" Sleep: A Randomized Controlled Trial.

BACKGROUND: Limited evidence suggests that consuming a higher-protein diet during weight loss improves subjective indices of sleep in overweight and obese adults. OBJECTIVE: We sought to a priori assess the effects of consuming the recommended versus a higher protein Healthy US-Style Eating Pattern during energy-restriction on sleep quality indices. DESIGN: Using a randomized, parallel study design, 51 adults (mean ± SEM age: 47 ± 1 y; BMI: 32.6 ± 0.5 kg/m2) consumed a controlled USDA Healthy US-Style Eating Pattern containing 750 kcal/d less than their estimated energy requirement for 12 wk. Participants were randomly assigned to consume either 5 or 12.5 oz-equivalent (eq)/d of protein foods. The additional 7.5 oz-eq/d came from animal-based protein sources and displaced primarily grains. Objective (wrist-worn actigraphy) and subjective (Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale) sleep quality indices were measured at baseline, week 6, and week 12. RESULTS: Among all participants, body mass decreased (-6.2 ± 0.4 kg). Dietary protein intake did not affect any objective or subjective sleep quality outcomes measured (repeated measures ANOVA). Over time, objective measures of time spent in bed, time spent sleeping, sleep onset latency, and time awake after sleep onset did not change; however, sleep efficiency improved (1 ± 1%; P = 0.027). Subjectively, global sleep scores [GSS: -2.7 ± 0.4 arbitrary units (au)] and daytime sleepiness scores (-3.8 ± 0.4 au; both P < 0.001) improved over time. The GSS improvement transitioned the participants from being categorized with "poor" to "good" sleep (GSS: >5 compared with ≤5 au of a 0-21 au scale; baseline 7.6 ± 0.4 au, week 12: 4.8 ± 0.4 au). CONCLUSIONS: Although objective sleep quality may not improve, adults who are overweight or obese and poor sleepers may become good sleepers while consuming either the recommended or a higher-protein energy-restricted Healthy US-Style Eating Pattern. This trial was registered at clinicaltrials.gov as NCT03174769.

Cardiovascular disease risk factor responses to a type 2 diabetes care model including nutritional ketosis induced by sustained carbohydrate restriction at 1 year: an open label, non-randomized, controlled study.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of death among adults with type 2 diabetes mellitus (T2D). We recently reported that glycemic control in patients with T2D can be significantly improved through a continuous care intervention (CCI) including nutritional ketosis. The purpose of this study was to examine CVD risk factors in this cohort. METHODS: We investigated CVD risk factors in patients with T2D who participated in a 1 year open label, non-randomized, controlled study. The CCI group (n = 262) received treatment from a health coach and medical provider. A usual care (UC) group (n = 87) was independently recruited to track customary T2D progression. Circulating biomarkers of cholesterol metabolism and inflammation, blood pressure (BP), carotid intima media thickness (cIMT), multi-factorial risk scores and medication use were examined. A significance level of P < 0.0019 ensured two-tailed significance at the 5% level when Bonferroni adjusted for multiple comparisons. RESULTS: The CCI group consisted of 262 participants (baseline mean (SD): age 54 (8) year, BMI 40.4 (8.8) kg m-2). Intention-to-treat analysis (% change) revealed the following at 1-year: total LDL-particles (LDL-P) (- 4.9%, P = 0.02), small LDL-P (- 20.8%, P = 1.2 × 10-12), LDL-P size (+ 1.1%, P = 6.0 × 10-10), ApoB (- 1.6%, P = 0.37), ApoA1 (+ 9.8%, P < 10-16), ApoB/ApoA1 ratio (- 9.5%, P = 1.9 × 10-7), triglyceride/HDL-C ratio (- 29.1%, P < 10-16), large VLDL-P (- 38.9%, P = 4.2 × 10-15), and LDL-C (+ 9.9%, P = 4.9 × 10-5). Additional effects were reductions in blood pressure, high sensitivity C-reactive protein, and white blood cell count (all P < 1 × 10-7) while cIMT was unchanged. The 10-year atherosclerotic cardiovascular disease (ASCVD) risk score decreased - 11.9% (P = 4.9 × 10-5). Antihypertensive medication use was discontinued in 11.4% of CCI participants (P = 5.3 × 10-5). The UC group of 87 participants [baseline mean (SD): age 52 (10) year, BMI 36.7 (7.2) kg m-2] showed no significant changes. After adjusting for baseline differences when comparing CCI and UC groups, significant improvements for the CCI group included small LDL-P, ApoA1, triglyceride/HDL-C ratio, HDL-C, hsCRP, and LP-IR score in addition to other biomarkers that were previously reported. The CCI group showed a greater rise in LDL-C. CONCLUSIONS: A continuous care treatment including nutritional ketosis in patients with T2D improved most biomarkers of CVD risk after 1 year. The increase in LDL-cholesterol appeared limited to the large LDL subfraction. LDL particle size increased, total LDL-P and ApoB were unchanged, and inflammation and blood pressure decreased. Trial registration Clinicaltrials.gov: NCT02519309. Registered 10 August 2015.

Adopting a Mediterranean-Style Eating Pattern with Different Amounts of Lean Unprocessed Red Meat Does Not Influence Short-Term Subjective Personal Well-Being in Adults with Overweight or Obesity.

Background: Reducing red meat intake is commonly recommended. Limited observational studies suggest that healthy eating patterns with red meat are associated with improved quality of life. Objective: The secondary objectives of this randomized crossover controlled-feeding trial were to assess the effects of following a Mediterranean-style eating pattern (Med-Pattern) with different amounts of red meat on indexes of personal well-being (i.e., perceived quality of life, mood, and sleep) in overweight or obese adults. We hypothesized that following a Med-Pattern would improve these outcomes, independent of red meat intake amount. Methods: Forty-one participants [aged 46 ± 2 y; body mass index (kg/m2): 30.5 ± 0.6; n = 28 women, n = 13 men) were provided Med-Pattern foods for two 5-wk periods separated by 4 wk of self-selected eating. The Med-Red Pattern contained ∼500 g/wk (typical US intake), and the Med-Control Pattern contained ∼200 g/wk (commonly recommended intake in heart-healthy eating patterns) of lean, unprocessed beef or pork compensated with mainly poultry and dairy. Baseline and postintervention outcomes measured were perceived quality of life via the MOS 36-Item Short-Form Health Survey, version 2 (SF-36v2), daily mood states via the Profile of Mood States (POMS), sleep perceptions via the Pittsburgh Sleep Quality Index, and sleep patterns via actigraphy. Data were analyzed via a doubly repeated-measures ANOVA adjusted for age, sex, and body mass at each time point. Results: Following a Med-Pattern did not change domains of physical health, mental health, total mood disturbances, sleep perceptions, and sleep patterns but improved subdomains of physical health role limitations (SF-36v2: 93.6-96.7%; P = 0.038), vitality (SF-36v2: 57.9-63.0%; P = 0.020), and fatigue (POMS: 2.9-2.5 arbitrary units; P = 0.039). There were no differences between the Med-Red and Med-Control Patterns (time × pattern, P-interaction > 0.05). Conclusion: Following a Med-Pattern, independent of lean, unprocessed red meat intake, may not be an effective short-term strategy to meaningfully improve indexes of personal well-being in adults who are overweight or obese. This trial was registered at clinicaltrials.gov as NCT02573129.

High-Protein and High-Dietary Fiber Breakfasts Result in Equal Feelings of Fullness and Better Diet Quality in Low-Income Preschoolers Compared with Their Usual Breakfast.

Background: In the United States, 17% of children are currently obese. Increasing feelings of fullness may prevent excessive energy intake, lead to better diet quality, and promote long-term maintenance of healthy weight.Objective: The purpose of this study was to develop a fullness-rating tool (aim 1) and to determine whether a high-protein (HP), high-fiber (HF), and combined HP and HF (HPHF) breakfast increases preschoolers' feelings of fullness before (pre) and after (post) breakfast and pre-lunch, as well as their diet quality, as measured by using a composite diet quality assessment tool, the Revised Children's Diet Quality Index (aim 2).Methods: Children aged 4 and 5 y (n = 41; 22 girls and 19 boys) from local Head Start centers participated in this randomized intervention trial. Sixteen percent of boys and 32% of girls were overweight or obese. After the baseline week, children rotated through four 1-wk periods of consuming ad libitum HP (19-20 g protein), HF (10-11 g fiber), HPHF (19-21 g protein, 10-12 g fiber), or usual (control) breakfasts. Food intake at breakfast was estimated daily, and for breakfast, lunch, and snack on day 3 of each study week Student's t tests and ANOVA were used to determine statistical differences.Results: Children's post-breakfast and pre-lunch fullness ratings were ≥1 point higher than those of pre-breakfast (aim 1). Although children consumed, on average, 65 kcal less energy during the intervention breakfasts (P < 0.007) than during the control breakfast, fullness ratings did not differ (P = 0.76). Relative to the control breakfast, improved diet quality (12%) was calculated for the HP and HF breakfasts (P < 0.027) but not for the HPHF breakfast (aim 2).Conclusions: Post-breakfast fullness ratings were not affected by the intervention breakfasts relative to the control breakfast. HP and HF breakfasts resulted in higher diet quality. Serving HP or HF breakfasts may be valuable in improving diet quality without lowering feelings of satiation or satiety. This trial was registered at clinicaltrials.gov as NCT02122224.

Whey Protein Supplementation and Higher Total Protein Intake Do Not Influence Bone Quantity in Overweight and Obese Adults Following a 36-Week Exercise and Diet Intervention.

BACKGROUND: Controversy exists concerning the effects of higher total protein intake (TPro) on bone health, which may be associated with reduced bone mineral density (BMD). However, whey protein (WP) may induce bone formation because of its basic component, milk basic protein. OBJECTIVE: This study assessed the effects of WP supplementation, TPro, and change in TPro (postsupplementation - presupplementation) on BMD and bone mineral content (BMC; total body, lumbar spine, total femur, and femoral neck) in overweight and class I obese middle-aged adults following an exercise intervention. METHODS: This analysis used data from a double-blind, randomized, placebo-controlled 36-wk WP supplementation trial, wherein participants consumed a 1.7-MJ (400-kcal) supplement (0, 20, 40, or 60 g WP/d) along with their otherwise unrestricted diet while participating in a resistance and aerobic exercise intervention (3 d/wk). TPro was the summation of WP and habitual dietary intakes (4-d food record). Statistical analyses for WP were based on group and bone data [n = 186, 108 women; mean ± SD age: 49 ± 8 y; body mass index (BMI; in kg/m2): 30.1 ± 2.8], whereas TPro was based on dietary and bone data (n = 113, 70 women; age 50 ± 8 y; BMI 30.1 ± 2.9). RESULTS: WP supplementation, regardless of dose, did not influence BMD or BMC following the intervention. By using a multiple linear regression model, TPro (expressed as g/d or g · kg-1 · d-1) and change in TPro (expressed as g/d) were not associated with responses over time in total or regional BMD or BMC. By using a cluster analysis approach [<1.0 (n = 41), 1.0-1.2 (n = 28), and ≥1.2 g · kg-1 · d-1 (n = 44)], TPro was also not associated with responses in total or regional BMD or BMC over time. CONCLUSION: WP supplementation and total dietary protein intake did not negatively or beneficially influence bone quantity in overweight and obese adults during a 9-mo exercise intervention. This trial was registered at clinicaltrials.gov as NCT00812409.

Egg Consumption Increases Vitamin E Absorption from Co-Consumed Raw Mixed Vegetables in Healthy Young Men.

BACKGROUND: Most people living in the United States underconsume vitamin E, and dietary approaches to increase the absorption of vitamin E may help individuals to meet their body's needs. OBJECTIVE: We assessed the effect of adding cooked whole egg to a raw mixed-vegetable salad on α-tocopherol and γ-tocopherol absorption. METHODS: With the use of a randomized-crossover design, 16 healthy young men [mean ± SD age: 24 ± 4 y; mean ± SD body mass index (in kg/m2): 24 ± 2] consumed the same salad (all served with 3 g canola oil) with no egg [control (CON)], with 75 g cooked egg [low egg (LE)], or with 150 g cooked egg [high egg (HE)]; a 1-wk dietary washout period was included between trials. For the first 7 d of each trial, participants consumed a low-vitamin E diet to reduce plasma vitamin E concentrations. Blood was collected hourly for 10 h and the triacylglycerol-rich lipoprotein fractions (TRLs) were isolated. α-Tocopherol and γ-tocopherol concentrations in TRLs were analyzed and composite areas under the curve (AUCs) were calculated. RESULTS: The α-tocopherol 0- to 10-h AUCs (AUCs0-10 h) in TRLs was higher (P < 0.05) for the HE trial (least-squares mean ± SE: 981 ± 162 nmol/L ⋅ 10 h) than for the LE (311 ± 162 nmol/L ⋅ 10 h) and CON (117 ± 162 nmol/L ⋅10 h) trials, which did not differ from one another. The γ-tocopherol AUCs0-10 h in TRLs was also higher (P < 0.05) for the HE trial (402 ± 54 nmol/L ⋅ 10 h) than for the CON trial (72 ± 54 nmol/L ⋅ 10 h). CONCLUSION: The consumption of cooked whole eggs is an effective way to increase the absorption of α-tocopherol and γ-tocopherol from a co-consumed meal that naturally contains vitamin E, such as a raw mixed-vegetable salad, in healthy young men. This trial was registered at clinicaltrials.gov as NCT01951313.

Thyroid status, insulin sensitivity and glucose tolerance in overweight and obese adults before and after 36 weeks of whey protein supplementation and exercise training.

UNLABELLED: Research suggests that subclinical hypothyroidism (SHT) influences insulin sensitivity and glucose tolerance. Reductions in thyroid stimulating hormone (TSH) concentrations are associated with exercise training (ExTr), which improves insulin sensitivity and glucose uptake. PURPOSE: A secondary analysis of previously published data was conducted to examine the relationship between SHT, TSH and glucose homeostatic control at baseline and to assess the impact of ExTr on thyroid status and how SHT affects changes in insulin sensitivity after ExTr. MATERIALS AND METHODS: Data were obtained from a 36-week ExTr and whey protein supplementation intervention trial. Subjects (n = 304, 48 ± 7 years, females = 186) were randomized to a specific whey protein group (0, 20, 40, or 60 g per day) and all subjects participated in a resistance (2 d/wk) and aerobic (1 d/wk) training program. Testing was conducted at baseline and post-intervention. RESULTS: At baseline, 36% (n = 110) and 12% (n = 35) of subjects were classified with SHT based on the TSH ≥ 3 µIU/L or TSH ≥ 4.5 µIU/L cut-offs, respectively. No association was found between baseline TSH and baseline measures of glucose homeostatic control. Whey protein supplementation did not influence intervention outcomes. Post-intervention (n = 164), no change was observed in TSH. SHT did not affect changes in insulin sensitivity following ExTr. CONCLUSION: These results support that the health benefits of ExTr for the management of insulin resistance (IR) are not blunted by SHT.