Gestational weight gain outside the Institute of Medicine recommendations and adverse pregnancy outcomes: analysis using individual participant data from randomised trials.

BACKGROUND: High Body Mass Index (BMI) and gestational weight gain (GWG) affect an increasing number of pregnancies. The Institute of Medicine (IOM) has issued recommendations on the optimal GWG for women according to their pre-pregnancy BMI (healthy, overweight or obese). It has been shown that pregnant women rarely met the recommendations; however, it is unclear by how much. Previous studies also adjusted the analyses for various women's characteristics making their comparison challenging. METHODS: We analysed individual participant data (IPD) of healthy women with a singleton pregnancy and a BMI of 18.5 kg/m2 or more from the control arms of 36 randomised trials (16 countries). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were used to describe the association between GWG outside (above or below) the IOM recommendations (2009) and risks of caesarean section, preterm birth, and large or small for gestational age (LGA or SGA) infants. The association was examined overall, within the BMI categories and by quartile of GWG departure from the IOM recommendations. We obtained aOR using mixed-effects logistic regression, accounting for the within-study clustering and a priori identified characteristics. RESULTS: Out of 4429 women (from 33 trials) meeting the inclusion criteria, two thirds gained weight outside the IOM recommendations (1646 above; 1291 below). The median GWG outside the IOM recommendations was 3.1 kg above and 2.7 kg below. In comparison to GWG within the IOM recommendations, GWG above was associated with increased odds of caesarean section (aOR 1.50; 95%CI 1.25, 1.80), LGA (2.00; 1.58, 2.54), and reduced odds of SGA (0.66; 0.50, 0.87); no significant effect on preterm birth was detected. The relationship between GWG below the IOM recommendation and caesarean section or LGA was inconclusive; however, the odds of preterm birth (1.94; 1.31, 2.28) and SGA (1.52; 1.18, 1.96) were increased. CONCLUSIONS: Consistently with previous findings, adherence to the IOM recommendations seem to help achieve better pregnancy outcomes. Nevertheless, even in the context of clinical trials, women find it difficult to adhere to them. Further research should focus on identifying ways of achieving a healthier GWG as defined by the IOM recommendations.

Variations in reporting of outcomes in randomized trials on diet and physical activity in pregnancy: A systematic review.

AIM: Trials on diet and physical activity in pregnancy report on various outcomes. We aimed to assess the variations in outcomes reported and their quality in trials on lifestyle interventions in pregnancy. METHODS: We searched major databases without language restrictions for randomized controlled trials on diet and physical activity-based interventions in pregnancy up to March 2015. Two independent reviewers undertook study selection and data extraction. We estimated the percentage of papers reporting 'critically important' and 'important' outcomes. We defined the quality of reporting as a proportion using a six-item questionnaire. Regression analysis was used to identify factors affecting this quality. RESULTS: Sixty-six randomized controlled trials were published in 78 papers (66 main, 12 secondary). Gestational diabetes (57.6%, 38/66), preterm birth (48.5%, 32/66) and cesarian section (60.6%, 40/66), were the commonly reported 'critically important' outcomes. Gestational weight gain (84.5%, 56/66) and birth weight (87.9%, 58/66) were reported in most papers, although not considered critically important. The median quality of reporting was 0.60 (interquartile range 0.25, 0.83) for a maximum score of one. Study and journal characteristics did not affect quality. CONCLUSION: Many studies on lifestyle interventions in pregnancy do not report critically important outcomes, highlighting the need for core outcome set development.

Effect of weight loss on the cardiovascular risk profile of obese patients with psoriasis.

Psoriasis is associated with obesity and other cardiovascular risk factors including endothelial dysfunction. We aimed to investigate the effects of weight loss on the cardiovascular risk profile of obese patients with psoriasis. A randomised controlled study was conducted in which we measured the microvascular endothelial function with peripheral arterial tonometry (PAT), selected plasma markers of endothelial function, and traditional cardiovascular risk factors in 60 obese patients with psoriasis. The participants were randomised to either low-energy diet (n = 30) providing 800-1,000 kcal/day for 8 weeks followed by 8 weeks of reduced food intake reaching 1,200 kcal/day or normal healthy foods (n = 30) for 16 weeks. The intervention group lost significantly more weight than controls, which resulted in significant reductions of diastolic blood pressure, resting heart rate, total cholesterol, VLDL cholesterol, triglyceride, plasma glucose, glycated haemoglobin, and tissue plasminogen activator inhibitor. Microvascular endothelial function assessed by PAT remained unchanged. We conclude that certain components of the cardiovascular risk profile of obese patients with psoriasis can be significantly improved by weight reduction.

Changes in Plasma, Urine, and Fecal Metabolome after 16 Weeks of Consuming Dairy With Different Food Matrixes - A Randomized Controlled Trial.

SCOPE: Understanding the mode-of-action by which fermented dairy consumption influences health is of interest. The aim of this study is to elucidate the impact of the chemical-physical properties of the dairy matrix and postbiotic effects on the metabolomics response to fermented dairy consumption. METHODS AND RESULTS: Hundred males (Body Mass Index (BMI) 28.0-45.0 kg m-2, waist circumference ≥ 102 cm) are included in the study. During a 16-week intervention, the study subjects are instructed to consume 400 g per day of either 1) milk, 2) yogurt, 3) heat-treated yogurt, or 4) chemically acidified milk as part of their habitual diet. Nuclear Magnetic Resonance (NMR)-based metabolomics is conducted on plasma, urine, and fecal samples collected before and after the intervention. Both consumption of acidified milk and heat-treated yogurt resulted in changes in the fecal metabolome including decreases in the level of amino acids (leucine, valine, and threonine), and the branched-chain fatty acid (BCFA) isobutyrate that indicated an altered protein putrefaction, and proteolytic metabolism in the gut. In the plasma metabolome, an increased citrate is found for yogurt consumption. No difference in the urine metabolome is found. CONCLUSIONS: Our metabolomics analyses indicate that consumption of heat-treated yogurt and acidified milk exerted similar effects on the metabolic activity in the gut as yogurt consumption.

The effect of dairy products on liver fat and metabolic risk markers in males with abdominal obesity - a four-arm randomized controlled trial.

BACKGROUND & AIMS: In recent years, epidemiological studies have reported links between the consumption of fermented dairy products, such as yogurt, and health; however, evidence from human intervention trials is scarce and inconsistent. We aimed to investigate the effect of consumption of four different types of dairy products (two fermented and two non-fermented) on liver fat (primary outcome) and metabolic risk markers in males with abdominal obesity. METHODS: In this parallel randomized controlled trial with four arms, 100 males aged 30-70 years, with body mass index 28.0-45.0 kg/m2, and waist circumference ≥102 cm underwent a 16-weeks intervention where they were instructed to consume 400 g/day of either milk, yogurt, heat-treated yogurt, or acidified milk as part of their habitual diet. Liver fat was measured by magnetic resonance imaging. RESULTS: In the complete case analyses (n = 80), no effects of the intervention or differences between groups were detected in anthropometry or body composition including liver fat. Moreover, no effects were detected in inflammatory markers. Main effects of time were detected in blood pressure (decrease; P < 0.001), insulin (decrease; P < 0.001), C-peptide (decrease; P = 0.040), homeostatic model assessment for insulin resistance (decrease; P < 0.001), total cholesterol (decrease; P = 0.016), low-density lipoprotein (decrease; P = 0.033), high-density lipoprotein (decrease; P = 0.006), and alanine transaminase (decrease; P = 0.019). Interactions between group and time failed to reach significance. CONCLUSIONS: In conclusion, findings from our study do not confirm that fermented yogurt products are superior in reducing liver fat or improving metabolic risk markers compared to non-fermented milk products. In fact, all intervention products (both fermented yogurt products and non-fermented milk products) did not affect liver fat and caused largely similar modest favorable changes in some metabolic risk markers. The study was registered at www. CLINICALTRIALS: gov (# NCT04755530).

A high protein low glycemic index diet has no adverse effect on blood pressure in pregnant women with overweight or obesity: a secondary data analysis of a randomized clinical trial.

Objectives: The objective of this analysis was to evaluate the effect of a diet rich in animal protein and low in glycemic index on blood pressure during pregnancy. Design: This post hoc, secondary data analysis of a randomized controlled trial, evaluated blood pressure in pregnant participants who were randomized either to an ad libitum diet with high protein and low glycemic index, rich in dairy and seafood, or an ad libitum control diet according to national recommendations. Setting: The study occurred in pregnant women in Copenhagen, Denmark. Sample: A total of 279 pregnant females with overweight or obesity were enrolled. Methods and outcome measure: Blood pressure was measured at 5 timepoints during pregnancy from gestational week 15 through week 36, and blood pressure between groups was compared. Results: There were no differences between diet arms in systolic or diastolic blood pressure over time. There were also no differences in most blood-pressure-related pregnancy complications, including the prevalence of premature birth, preeclampsia, or hypertension, but the frequency of total cesarean sections was lower in the active than the control group (16 out of 104 vs. 30 out of 104) (p = 0.02). Conclusion: Increased animal protein intake was not associated with changes in blood pressure in pregnant women with overweight or obesity. Clinical trial registration: [ClinicalTrials.gov], identifier [NCT01894139].

A high-protein low-glycemic index diet attenuates gestational weight gain in pregnant women with obesity: the "An optimized programming of healthy children" (APPROACH) randomized controlled trial.

BACKGROUND: Prepregnancy overweight and excessive gestational weight gain (GWG) increase the risk of complications and offspring obesity. OBJECTIVES: We aimed to investigate the effect of a high-protein low-glycemic index (HPLGI) diet on GWG, birth weight, and risk of gestational complications in pregnant women with obesity. METHODS: A total of 279 women with prepregnancy overweight or obesity (BMI: 28-45 kg/m2), between 18 and 45 y old, and in their late first trimester with singleton pregnancies, were randomly assigned to 1 of 2 ad libitum diets: a high-protein low-glycemic index diet (HPLGI: 25%-28% of energy from protein and glycemic index ≤ 55) and a moderate-protein moderate-glycemic index diet (MPMGI: 15%-18% of energy from protein and glycemic index ∼60). Diets were consumed from gestational week 15 and throughout pregnancy. Participants received dietary guidance by a clinical dietician 9 times to facilitate adherence. RESULTS: Out of 141 and 138 women randomly assigned to the HPLGI and MPMGI diets, 105 and 104 completed the intervention, respectively (75%). In the available case analyses, GWG was 6.8 ± 1.3 kg among women assigned the HPLGI diet and this was significantly lower, by -1.7 kg (95% CI: -2.8, -0.5 kg; P = 0.004), than the GWG of 8.5 ± 1.3 kg among women assigned the MPMGI diet. There were no significant differences between diets on major neonatal outcomes (birth weight and other anthropometric measures). The incidence of composite pregnancy complications was lower for the HPLGI than for the MPMGI diet (35.4% compared with 53.7%, respectively; P = 0.009), including cesarean delivery (15.4% compared with 28.8%, respectively; P = 0.03). There were no reported maternal, fetal, or neonatal deaths. Incidence of miscarriages (1%-2%) did not differ between groups. CONCLUSIONS: A moderate increase in dietary protein in conjunction with a reduction in glycemic index during the last 2 trimesters of pregnancy reduced GWG and limited complications and cesarean deliveries among women with overweight or obesity.

Unprocessed red meat in the dietary treatment of obesity: a randomized controlled trial of beef supplementation during weight maintenance after successful weight loss.

BACKGROUND: Consumption of unprocessed red meat in randomized trials has no adverse effects on cardiovascular risk factors and body weight, but its physiological effects during weight loss maintenance are not known. OBJECTIVES: We sought to investigate the effects of healthy diets that include small or large amounts of red meat on the maintenance of lost weight after successful weight loss, and secondarily on body composition (DXA), resting energy expenditure (REE; indirect calorimetry), and cardiometabolic risk factors. METHODS: In this 5-mo parallel randomized intervention trial, 108 adults with BMI 28-40 kg/m2 (45 males/63 females) underwent an 8-wk rapid weight loss period, and those who lost ≥8% body weight (n = 80) continued to ad libitum weight maintenance diets for 12 wk: a moderate-protein diet with 25 g beef/d (B25, n = 45) or a high-protein diet with 150 g beef/d (B150, n = 35). RESULTS: In per protocol analysis (n = 69), mean body weight (-1.2 kg; 95% CI: -2.1, -0.3 kg), mean fat mass (-2.7 kg; 95% CI: -3.4, -2.0 kg), and mean body fat content (-2.6%; 95% CI: -3.1, -2.1%) decreased during the maintenance phase, whereas mean lean mass (1.5 kg; 95% CI: 1.0, 2.0 kg) and mean REE (51 kcal/d; 95% CI: 15, 86 kcal/d) increased, with no differences between groups (all P > 0.05). Results were similar in intention-to-treat analysis with multiple imputation for dropouts (20 from B150 compared with 19 from B25, P = 0.929). Changes in cardiometabolic risk factors were not different between groups, the general pattern being a decrease during weight loss and a return to baseline during weight maintenance (and despite the additional mild reduction in weight and fat mass). CONCLUSIONS: Healthy diets consumed ad libitum that contain a little or a lot of unprocessed beef have similar effects on body weight, energy metabolism, and cardiovascular risk factors during the first 3 mo after clinically significant rapid weight loss.

Chemically acidified, live and heat-inactivated fermented dairy yoghurt show distinct bioactive peptides, free amino acids and small compounds profiles.

Previous studies found variations in the health-promoting effects of consuming different dairy products. This study aims at investigating the chemical composition of microbial fermented yogurt, chemically acidified yogurt and whole milk to understand the differences in the effects these products exert on human health. For this purpose, peptides and small compounds present in the products were examined using a combination of liquid chromatography mass spectrometry and nuclear magnetic resonance spectroscopic techniques. Results revealed that each product had its own characteristic peptide, free amino acid and small compound profile, and database search for bioactivity disclosed that fermented yogurt manufactured using a starter culture is associated with a higher bioactivity potential than chemically acidified yogurt or whole milk. Additional cold storage (14 days) further enhances the bioactivity potential of fermented yogurt while heat-inactivation, ensuring long shelf-life, modulates the proteins available for proteolysis and thereby the peptide profile generated.

A protein-supplemented very-low-calorie diet does not mitigate reductions in lean mass and resting metabolic rate in subjects with overweight or obesity: A randomized controlled trial.

BACKGROUND & AIMS: The European Food Safety Authority recently recommended an increase in the protein content of total diet replacement (TDR) products from 50 to 75 g/day. The rationale was to minimize reductions in lean mass (LM) and resting metabolic rate (RMR) that occur with weight loss, and thereby facilitate maintenance of lost weight. We sought to directly compare the efficacy of TDR regimens with the new vs the current protein requirement. METHODS: We randomized 108 adults with overweight or obesity (body mass index 28-40 kg/m2) to very-low-calorie diets (VLCD) with either 52 or 77 g/day protein for 8 weeks (total energy intake of 600 or 700 kcal/day, respectively). LM was determined by dual energy X-ray absorptiometry and RMR by indirect calorimetry. RESULTS: Attrition rate was 22% in both groups. Both VLCDs decreased body weight, fat mass, LM, and RMR (all P < 0.05). Significant time-by-group interactions were detected for weight and fat mass (both P < 0.05), with corresponding reductions being smaller in the higher-protein than the standard-protein VLCD, likely because of the added calories. On the other hand, reductions in LM (6% from baseline) and RMR (9-10% from baseline) did not differ between groups (P = 0.155 and P = 0.389, respectively), and the contribution of LM to total weight loss was identical (27 ± 2% of lost weight, P = 0.973). CONCLUSIONS: Our results indicate that the proposed increase in the protein content of TDR products does not attenuate reductions in LM and RMR in individuals with overweight and obesity who are treated with <800 kcal/day VLCDs for 2 months. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov # NCT04156165.

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

CONTEXT: Interventions targeting maternal obesity are a healthcare and public health priority. OBJECTIVE: The objective of this review was to evaluate the adequacy and effectiveness of the methodological designs implemented in dietary intervention trials for obesity in pregnancy. DATA SOURCES: A systematic review of the literature, consistent with PRISMA guidelines, was performed as part of the International Weight Management in Pregnancy collaboration. STUDY SELECTION: Thirteen randomized controlled trials, which aimed to modify diet and physical activity in overweight and obese pregnant women, were identified. DATA SYNTHESIS: There was significant variability in the content, delivery, and dietary assessment methods of the dietary interventions examined. A number of studies demonstrated improved dietary behavior in response to diet and/or lifestyle interventions. Nine studies reduced gestational weight gain. CONCLUSION: This review reveals large methodological variability in dietary interventions to control gestational weight gain and improve clinical outcomes in overweight and obese pregnant women. This lack of consensus limits the ability to develop clinical guidelines and apply the evidence in clinical practice.

Effect of weight loss on the severity of psoriasis: a randomized clinical study.

IMPORTANCE: Psoriasis is associated with adiposity and weight gain increases the severity of psoriasis and the risk of incident psoriasis. Therefore, we aimed to measure the effect of weight reduction on the severity of psoriasis in obese patients with psoriasis. OBJECTIVE: To assess the effect of weight reduction on the severity of psoriasis in overweight patients. DESIGN: Sixty obese patients with psoriasis from our dermatology outpatient clinic were enrolled in a prospective randomized clinical trial in which they were allocated to a control group or an intervention group. SETTING: University hospital outpatient dermatology clinic. PARTICIPANTS: We included 60 of 69 eligible overweight patients with psoriasis (body mass index [calculated as weight in kilograms divided by height in meters squared], 27-40; aged 25-71 years). INTERVENTIONS: The intervention group received a low-energy diet (LED) (800-1000 kcal/d) for 8 weeks to induce weight loss, followed by 8 weeks of reintroduction of normal food intake, reaching 1200 kcal/d. The control group was instructed to continue eating ordinary healthy foods. MAIN OUTCOMES AND MEASURES: Psoriasis Area and Severity Index (PASI) after 16 weeks, with Dermatology Life Quality Index (DLQI) as a secondary end point. RESULTS: The median PASI for all patients was 5.4 (interquartile range, 3.8-7.6) at baseline. At week 16, the mean body weight loss was 15.4 kg (95% CI, 12.3-18.5 kg; P < .001) greater in the intervention group than in the control group. The corresponding mean differences in PASI and DLQI, also in favor of the LED group, were -2.0 (95% CI, 4.1 to -0.1; P = .06) and -2.0 (95% CI, -3.6 to -0.3; P = .02), respectively. CONCLUSIONS AND RELEVANCE: Treatment with an LED showed a trend in favor of clinically important PASI improvement and a significant reduction in DLQI in overweight patients with psoriasis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01137188.