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Pre-meal protein intake alters postprandial plasma metabolome in subjects with metabolic syndrome.
Pekmez, CT, Bjørnshave, A, Pratico, G, Hermansen, K, Dragsted, LO
European journal of nutrition. 2020;(5):1881-1894
Abstract
PURPOSE We examined the effect on the postprandial plasma metabolome of protein pre-meals before a fat-rich main meal. METHODS Two randomized, cross-over meal studies were conducted to test the dose-response effect (0 g, 10 g, 20 g) of a pre-meal with whey protein (WP) (PREMEAL I), and the effect of protein quality (10 g WP, casein, or gluten) and timing (- 15 min vs - 30 min) of the pre-meal (PREMEAL II). Participants with metabolic syndrome received one of the test meals on each test day, - 15 min (or - 30 min) prior to a standardized fat-rich breakfast. Plasma samples were collected at - 15 min (or - 30 min), 0, 120, 240 a nd 360 min and analyzed using liquid chromatography-mass spectrometry with an untargeted method. RESULTS Pre-meal WP intake elevated plasma branched-chain amino acids (BCAA), aromatic amino acids and methionine and decreased plasma LPC (16:0) and PC (32:1) levels before the main meal. Early (- 15 to 0 min) aromatic amino acids and BCAA in response to pre-meal WP partially predict the glucose and insulin response after the main meal. A pre-meal with WP altered the postprandial plasma metabolic pattern of acyl-carnitines, specific PCs, LPCs and LPEs, betaine, citric acid, linoleic acid, and β-hydroxypalmitic acid compared to no pre-meal. The casein and WP pre-meals exhibited similar postprandial amino acid responses whereas a pre-meal with gluten resulted in lower levels of plasma amino acids and its metabolites. CONCLUSION A pre-meal with protein affects the postprandial metabolic pattern indicating facilitated glucose and lipid disposal from plasma in participants with metabolic syndrome.
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Rationale and study design for lifestyle intervention in preparation for pregnancy (LIPP): A randomized controlled trial.
Erickson, ML, Mey, JT, Axelrod, CL, Paul, D, Gordesky, L, Russell, K, Barkoukis, H, O'Tierney-Ginn, P, Fielding, RA, Kirwan, JP, et al
Contemporary clinical trials. 2020;:106024
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INTRODUCTION Maternal obesity increases neonatal risk for obesity and metabolic syndrome later in life. Prior attempts to break this intergenerational obesity cycle by limiting excessive gestational weight gain have failed to reduce neonatal adiposity. Alternatively, pre-conception lifestyle interventions may improve the in utero metabolic milieu during early pregnancy leading to improved fetal outcomes. This randomized controlled trial (RCT) is evaluating whether a lifestyle intervention to reduce weight and improve maternal metabolism in preparation for pregnancy (LIPP) attenuates neonatal adiposity, compared to standard medical advice. MATERIAL AND METHODS Overweight/class 1 obese women after a previous pregnancy, ~12 weeks postpartum, preparing for a subsequent pregnancy, will be block randomized (1:1) to either LIPP or standard of care in a parallel design. Randomization is stratified by lactation status and overweight vs. class 1 obesity. The LIPP program consists of intensive short-term weight loss followed by weight maintenance until conception using supervised exercise and a low glycemic Mediterranean diet. PRIMARY OUTCOMES Group differences in neonatal adiposity at birth assessed by PEA POD and placental mitochondrial lipid metabolism. SECONDARY OUTCOMES Group differences in maternal pregravid and gestational body composition, insulin sensitivity, β-cell function, fasting metabolic and inflammatory biomarkers, and overall quality of life. Exploratory outcomes include umbilical cord blood insulin resistance, lipid profile and inflammation. DISCUSSION This RCT will determine the efficacy of maternal weight loss prior to pregnancy on reducing neonatal adiposity. Findings may change standard obstetrical care by providing Level 1 evidence on lifestyle interventions improving neonatal outcomes for women planning for pregnancy. CLINICAL TRIAL REGISTRATION NCT03146156.
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Hypoxia and exercise interactions on skeletal muscle insulin sensitivity in obese subjects with metabolic syndrome: results of a randomized controlled trial.
Mai, K, Klug, L, Rakova, N, Piper, SK, Mähler, A, Bobbert, T, Schulz-Menger, J, Spranger, J, Boschmann, M, Luft, FC
International journal of obesity (2005). 2020;(5):1119-1128
Abstract
BACKGROUND Physical activity improves insulin sensitivity in obesity. Hypoxia training is claimed to augment this effect. We tested the hypothesis that normobaric hypoxia training would improve insulin sensitivity in obese patients with metabolic syndrome. METHODS In a randomized controlled trial, 23 obese men with metabolic syndrome who were not informed of the FiO2 conditions underwent a 6-week physical exercise intervention under ambient (n = 11; FiO2 21%) conditions or hypoxia (n = 12; FiO2 15%) using a normobaric hypoxic chamber. Three 60-min sessions of interval training were performed each week at 60% of individual V̇O2max. Assessment of myocellular insulin sensitivity by euglycemic hyperinsulinemic clamp was performed in 21 of these subjects before and after 6 weeks of training. Comprehensive phenotyping also included biopsies of subcutaneous adipose tissues. RESULTS The intermittent moderate physical exercise protocol did not substantially change the myocellular insulin sensitivity within 6 weeks under normoxic conditions (ISIClamp: 0.035 (IQR 0.016-0.075) vs. 0.037 (IQR 0.026-0.056) mg* kg-1 *min-1/(mU* l-1); p = 0.767). In contrast, ISIClamp improved during hypoxia training (0.028 (IQR 0.018-0.035) vs. 0.038 (IQR 0.024-0.060) mg * kg-1 *min-1/(mU *l-1); p < 0.05). Between group comparison of ISIClamp change revealed a small difference between groups (Cohen's d = 0.26). Within the hypoxic group, improvement of ISIClamp during training was associated with individual increase of circulating vascular endothelial growth factor (VEGF) levels (r = 0.678, p = 0.015), even if mean VEGF levels were not modified by any training condition. Atrial natriuretic peptide (ANP) system components were not associated with increased ISIClamp during hypoxic training. CONCLUSIONS Physical training under hypoxic conditions could partially augment the favorable effects of exercise alone on myocellular insulin sensitivity in obese men with metabolic syndrome. Concomitant changes in VEGF might represent an underlying pathophysiological mechanism.
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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.
Kris-Etherton, PM, Stewart, PW, Ginsberg, HN, Tracy, RP, Lefevre, M, Elmer, PJ, Berglund, L, Ershow, AG, Pearson, TA, Ramakrishnan, R, et al
The Journal of nutrition. 2020;(8):2089-2100
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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. Study 1: healthy participants (n = 103) were provided with (8 wk) an average American diet [AAD; designed to provide 37% of energy (%E) as fat, 16% SFA], a Step 1 diet (30%E fat, 9% SFA), and a diet low in SFA (Low-Sat; 26%E fat, 5% SFA). Study 2: participants (n = 85) at risk for CVD and metabolic syndrome (MetSyn) were provided with (7 wk) an AAD, a step 1 diet, and a high-MUFA diet (designed to provide 37%E fat, 8% SFA, 22% MUFA). RESULTS Study 1: compared with AAD, the Step 1 and Low-Sat diets decreased mean factor VIIc by 1.8% and 2.6% (overall P = 0.0001), increased mean fibrinogen by 1.2% and 2.8% (P = 0.0141), and increased mean square root PAI-1 by 0.0% and 6.0% (P = 0.0037), respectively. Study 2: compared with AAD, the Step 1 and high-MUFA diets decreased mean factor VIIc by 4.1% and 3.2% (overall P < 0.0001), increased mean fibrinogen by 3.9% and 1.5% (P = 0.0083), and increased mean square-root PAI-1 by 2.0% and 5.8% (P = 0.1319), respectively. CONCLUSIONS Replacing SFA with carbohydrate decreased factor VIIc and increased fibrinogen in healthy and metabolically unhealthy individuals and also increased PAI-1 in healthy subjects. Replacing SFA with MUFA decreased factor VIIc and increased fibrinogen but less than carbohydrate. Our results indicate an uncertain effect of replacing SFA with carbohydrate or MUFA on cardiometabolic risk because of small changes in hemostatic factors and directionally different responses to decreasing SFA. This trial was registered at https://clinicaltrials.gov/ct2/show/NCT00000538?term=NCT00000538&rank=1 as NCT00000538.
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Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.
Boden, WE, Miller, MG, McBride, R, Harvey, C, Snabes, MC, Schmidt, J, McGovern, ME, Fleg, JL, Desvigne-Nickens, P, Anderson, T, et al
American heart journal. 2020;:65-76
Abstract
BACKGROUND Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest. OBJECTIVES Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up. METHODS In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL ["low T"] vs. ≥300 ng/dL ["normal T"]) on rates of pre-specified CV outcomes, using Cox proportional hazards models. RESULTS Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. CONCLUSIONS In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke. CONDENSED ABSTRACT In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The "low T" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.
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Effects of using high-intensity interval training and calorie restriction in different orders on metabolic syndrome: A randomized controlled trial.
So, R, Matsuo, T
Nutrition (Burbank, Los Angeles County, Calif.). 2020;:110666
Abstract
OBJECTIVE Studies of the effectiveness of high-intensity interval training (HIIT) combined with calorie restriction (CR) are very limited, and the most effective order of intervention is unclear. Therefore, we investigated the impact of time-efficient HIIT with CR intervention on metabolic syndrome (MetS) and the impact of the intervention order on changes in MetS risk factors. METHODS Thirty-two participants with MetS underwent an 11-wk intervention program comprising 8 wk of HIIT and 3 wk of CR. Participants were randomly assigned to either the HIIT-then-CR or CR-then-HIIT groups. Thereafter, the CR-then-HIIT group performed a further 8 wk of training once per week after the initial intervention period. Risk factors for MetS and peak oxygen uptake (VO2peak) were assessed during the entire study period. RESULTS During the 11-wk intervention period, body composition, MetS risk factors, and VO2peak significantly improved in both groups. No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group. During the postintervention period (8 wk), a single weekly HIIT session prevented VO2peak reduction in the CR-then-HIIT group (-2.0 ± 7.2%; P = 0.31). CONCLUSIONS The time-efficient intervention program with HIIT and CR had a beneficial effect on MetS; however, the intervention order had no influence on the changes in risk factors.
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Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT).
Ensenyat, A, Espigares-Tribo, G, Machado-Da-Silva, L, Sinfreu-Bergués, X, Blanco, A
Journal of physical activity & health. 2020;(7):744-755
Abstract
BACKGROUND The purpose of this study was to evaluate the feasibility and effectiveness of a high-intensity semisupervised exercise program alongside lifestyle counseling as an intervention for managing cardiometabolic risk in sedentary adults. METHODS A 40-week 3-arm randomized controlled clinical trial (16-wk intervention and 24-wk follow-up) was used. Seventy-five sedentary adults (34-55 y) with at least 1 cardiometabolic risk factor were randomized into one of the following arms: (1) aerobic interval training (AIT) plus lifestyle counseling (n = 25), (2) low- to moderate-intensity continuous training plus lifestyle counseling (traditional continuous training, TCT) (n = 27), or (3) lifestyle counseling alone (COU) (n = 23). Metabolic syndrome severity scores, accelerometer-based physical activity, and self-reported dietary habits were assessed at baseline, after the intervention, and at follow-up. RESULTS AIT was well accepted with high enjoyment scores. All groups showed similar improvements in metabolic syndrome severity scores (standardized effect size = 0.46) and dietary habits (standardized effect size = 0.30). Moderate to vigorous physical activity increased in all study groups, with the number of responders higher in AIT and TCT groups (50%) than in COU group (21%). Both AIT and TCT had a greater impact on sedentary behavior than COU (63.5% vs 30.4% responders). CONCLUSIONS AIT appears to be a feasible and effective strategy in sedentary individuals with cardiometabolic risk factors. AIT could be included in intervention programs tackling unhealthy lifestyles.
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Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.
Solomon, DH, Glynn, RJ, Karlson, EW, Lu, F, Corrigan, C, Colls, J, Xu, C, MacFadyen, J, Barbhaiya, M, Berliner, N, et al
Annals of internal medicine. 2020;(6):369-380
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BACKGROUND Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred. OBJECTIVE To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo. DESIGN Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333). SETTING North America. PARTICIPANTS Adults with known cardiovascular disease and diabetes or metabolic syndrome. INTERVENTION Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week. MEASUREMENTS Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication. RESULTS After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]). LIMITATION The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period. CONCLUSION Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased. PRIMARY FUNDING SOURCE National Institutes of Health.
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Leisure-Time Physical Activity, Sedentary Behaviour and Diet Quality are Associated with Metabolic Syndrome Severity: The PREDIMED-Plus Study.
Gallardo-Alfaro, L, Bibiloni, MDM, Mascaró, CM, Montemayor, S, Ruiz-Canela, M, Salas-Salvadó, J, Corella, D, Fitó, M, Romaguera, D, Vioque, J, et al
Nutrients. 2020;(4)
Abstract
Healthy lifestyle factors, such as physical activity (PA) and Mediterranean diet (MD), decrease the likelihood of developing metabolic syndrome (MetS). The aim of this study was to report main lifestyle components and related factors according to the MetS severity. Cross-sectional analysis was done of baseline lifestyle factors from 5739 participants with overweight/obesity and MetS features (aged 55-75 years) included in the PREDIMED-PLUS primary cardiovascular prevention randomized trial. Participants were categorized in tertiles according to a validated MetS severity score (MetSSS). Anthropometrics, visceral adiposity index, dietary nutrient intake, biochemical marker levels, as well as a Dietary Inflammatory Index and depression symptoms (Beck Depression Inventory-II) were measured. Diet quality was assessed using a 17-item energy-restricted MD questionnaire. Duration and intensity of PA was self-reported using the Minnesota-REGICOR Short Physical Activity Questionnaire. Sedentary behaviours were measured using the Spanish version of the Nurses' Health Study questionnaire. The 30 s chair stand test was also assessed. Participants with highest MetSSS showed higher values of cardiovascular risk factors (except for total cholesterol and LDL cholesterol), depression risk, sedentary and TV viewing time, and lower moderate and vigorous leisure-time physical activity (LTPA). Highest MetSSS participants tended to a pro-inflammatory dietary pattern and tended to lower MD adherence. In addition, they showed lower carbohydrate and nut intake and higher intake of protein, saturated and trans fatty acids, cholesterol, iodine, sodium, red and processed meat products, other oils different from olive oil and spirit alcoholic drinks. The highest MetS severity score was associated with lower moderate and vigorous LTPA and higher sedentary time and depression risk, as they tended to a pro-inflammatory dietary pattern and lower MD adherence.
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Reducing metabolic syndrome through a community-based lifestyle intervention in African American women.
Mamun, A, Kitzman, H, Dodgen, L
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2020;(10):1785-1794
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BACKGROUND AND AIMS Metabolic syndrome (MetS) increases the risk of cardiovascular disease and type 2 diabetes. Despite a higher prevalence of MetS in African American (AA) women, little is known about the effectiveness of lifestyle interventions in improving metabolic markers in this high-risk group. This study investigated the effectiveness of a community-based lifestyle intervention delivered by lay health coaches in reducing MetS among AA women. METHODS AND RESULTS A cluster-randomized diabetes prevention program (DPP) was implemented in 11 churches utilizing a community-based participatory research (CBPR) approach to develop and deliver the interventions. A total of 221 adults, AA women who were overweight or obese, and did not have diabetes were included in this study. The prevalence of MetS was 42.08% before receiving the DPP intervention and 31.22% after the intervention that represented a 10.86% absolute reduction and a 25.81% relative reduction from baseline. The adjusted odds ratio (OR) of being free from MetS at post-intervention in contrast to baseline was 2.14 (p = 0.02). Factors that increased the odds of being free from MetS were younger age, reduction in intake of total calories, total fat, saturated and trans-fat, and dietary sodium. CONCLUSION A faith adapted lifestyle intervention held in church settings and delivered by minimally trained lay health coaches reduced the prevalence of MetS in AA women who were overweight or obese. Findings from this study can be used to translate evidence into public health programs at the community level for the prevention of type 2 diabetes and cardiovascular disease. CLINICAL TRIAL REGISTRATION NUMBER NCT04082702 (www.clinicaltrials.gov).