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).

Validation of a food frequency questionnaire in the assessment of dietary glycemic index, glycemic load, and protein intake in pregnant women with obesity.

OBJECTIVES: Studies suggest that diets with a low glycemic index and high protein are favorable in aiding weight loss and improving weight maintenance; however, methods to measure dietary intake are comprehensive both for the participant and the study staff. We aimed to validate the accuracy of the dietary glycemic index and protein intake assessed through a food frequency questionnaire against a 4-d weighed food record in Danish pregnant women with obesity. METHODS: A total of 31 pregnant women completed a 29-item food frequency questionnaire and a 4-d weighed food record with overlapping time periods. The women had a mean (± SD) age of 30.6 ± 3.9 y and a prepregnancy body mass index of 33.9 ± 3.5 kg/m2. We evaluated the validity of the food frequency questionnaire by Bland-Altman plots and the Spearman correlation coefficient. RESULTS: The results of the validation study found good acceptance of the 29-item food frequency questionnaire. The mean intake of glycemic index, glycemic load, and protein intake of the 29-item food frequency questionnaire and the weighed food record correlated well, although intake data of the 29-item food frequency questionnaire tended to be lower. Spearman correlation coefficients had moderate to high correlations for glycemic index (ρ = 0.73; P < 0.001) and protein intake (ρ = 0.70; P < 0.001). A moderate correlation was found for glycemic load (ρ = 0.55; P = 0.002). There was no correlation for carbohydrates (ρ = 0.21; P = 0.253). CONCLUSION: The results suggest no risk of bias between the two methods of assessment; hence, a 29-item food frequency questionnaire can be used to assess the mean glycemic index, glycemic load, and protein intake in pregnant women with obesity.

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].

Gestational weight gain in women with pre-pregnancy overweight or obesity and anthropometry of infants at birth.

Objective: To examine the association of gestational weight gain (GWG) among women with pre-pregnancy overweight or obesity with infant weight and BMI z-score at birth. Methods: This study is a secondary analysis of a randomized controlled trial including data from 208 infants at birth born by mothers with pre-pregnancy BMI between 28 and 45 kg/m2 who completed the APPROACH study (randomized to a high-protein low-glycemic index diet or a moderate-protein moderate-glycemic index diet). This analysis pooled the two diet treatment groups together and data were analyzed using a linear mixed model. Results: Limiting GWG by 1 kg was associated with lower birthweight (-16 g, P = 0.003), BMI z-score (-0.03SD, P = 0.019), weight z-score (-0.03SD, P = 0.004), and infant abdominal circumference (-0.06 cm, P = 0.039). Infants born by mothers whose GWG was ≤9 kg weighed less (122 g, 95% CI: 6-249, P = 0.040), had similar BMI z-score (0.2SD, 95% CI: -0.06 to 0.55, P = 0.120), and lower incidence of emergency cesarean deliveries (11.5% vs. 23.1%, P = 0.044) compared to infants born by mothers whose GWG was >9 kg. When women were classified into GWG quartiles, women in Q1 (GWG range: -7.0 to 3.2 kg) gave birth to smaller infants (3,420 g, P = 0.015) with lower BMI z-score (-0.5SD, P = 0.041) than women in Q2 (3.3-7.1 kg), Q3 (7.2-10.9 kg) and Q4 (11.1-30.2 kg). Conclusions: Limiting GWG among women with pre-pregnancy overweight or obesity was associated with lower infant weight, BMI z-score, weight z-score, and abdominal circumference at birth. Moreover, GWG below the Institute of Medicine guideline of a maximum of 9 kg was associated with lower birthweight and fewer emergency cesarean deliveries.

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.

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.

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.

Meat and Human Health-Current Knowledge and Research Gaps.

Meat is highly nutritious and contributes with several essential nutrients which are difficult to obtain in the right amounts from other food sources. Industrially processed meat contains preservatives including salts, possibly exerting negative effects on health. During maturation, some processed meat products develop a specific microbiota, forming probiotic metabolites with physiological and biological effects yet unidentified, while the concentration of nutrients also increases. Meat is a source of saturated fatty acids, and current WHO nutrition recommendations advise limiting saturated fat to less than ten percent of total energy consumption. Recent meta-analyses of both observational and randomized controlled trials do not support any effect of saturated fat on cardiovascular disease or diabetes. The current evidence regarding the effect of meat consumption on health is potentially confounded, and there is a need for sufficiently powered high-quality trials assessing the health effects of meat consumption. Future studies should include biomarkers of meat intake, identify metabolic pathways and include detailed study of fermented and other processed meats and their potential of increasing nutrient availability and metabolic effects of compounds.

The effects of dietary and lifestyle interventions among pregnant women with overweight or obesity on early childhood outcomes: an individual participant data meta-analysis from randomised trials.

BACKGROUND: The impact of maternal obesity extends beyond birth, being independently associated with an increased risk of child obesity. Current evidence demonstrates that women provided with a dietary intervention during pregnancy improve their dietary quality and have a modest reduction in gestational weight gain. However, the effect of this on longer-term childhood obesity-related outcomes is unknown. METHODS: We conducted an individual participant data meta-analysis from RCTs in which women with a singleton, live gestation between 10+0 and 20+0 weeks and body mass index (BMI) ≥ 25 kg/m2 in early pregnancy were randomised to a diet and/or lifestyle intervention or continued standard antenatal care and in which longer-term maternal and child follow-up at 3-5 years of age had been undertaken. The primary childhood outcome was BMI z-score above the 90th percentile. Secondary childhood outcomes included skinfold thickness measurements and body circumferences, fat-free mass, dietary and physical activity patterns, blood pressure, and neurodevelopment. RESULTS: Seven primary trials where follow-up of participants occurred were identified by a systematic literature search within the International Weight Management in Pregnancy (i-WIP) Collaborative Group collaboration, with six providing individual participant data. No additional studies were identified after a systematic literature search. A total of 2529 children and 2383 women contributed data. Approximately 30% of all child participants had a BMI z-score above the 90th percentile, with no significant difference between the intervention and control groups (aRR 0.97; 95% CI 0.87, 1.08; p=0.610). There were no statistically significant differences identified for any of the secondary outcome measures. CONCLUSIONS: In overweight and obese pregnant women, we found no evidence that maternal dietary and/or lifestyle intervention during pregnancy modifies the risk of early childhood obesity. Future research may need to target the pre-conception period in women and early childhood interventions. TRIAL REGISTRATION: PROSPERO, CRD42016047165.

Efficacy of Dietary Manipulations for Depleting Intrahepatic Triglyceride Content: Implications for the Management of Non-alcoholic Fatty Liver Disease.

PURPOSE OF REVIEW: Understanding the effects of dietary manipulations on intrahepatic triglyceride (IHTG) balance will have important implications for the prevention and treatment of non-alcoholic fatty liver disease (NAFLD). RECENT FINDINGS: Reducing calorie intake to induce weight loss is the most potent intervention to decrease IHTG. Carbohydrate restriction during the initial stages of weight loss may be particularly beneficial, but at later stages, the amount of weight loss predominates over diet composition. By contrast, during weight stability, restricting calories from fat seems to be optimal for depleting liver fat. The degree of dietary fat saturation and the glycemic index of the carbohydrate have inconsistent effects on IHTG. Recently, the matrix of some foods (e.g., dairy) has been inversely associated with NAFLD. Dietary macronutrients differ in their effects on liver fat depending on the energy balance and the matrix of the food in which they are consumed. Therefore, investigations into dietary approaches for managing NAFLD should shift their perspective from that of isolated nutrients to that of whole foods and diets and include useful mechanistic insights.

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.

Effects of Full-Fat and Fermented Dairy Products on Cardiometabolic Disease: Food Is More Than the Sum of Its Parts.

Current dietary recommendations to limit consumption of saturated fat are largely based on early nutrition studies demonstrating a direct link between dietary saturated fat, elevated blood cholesterol levels, and increased risk of cardiovascular disease. As full-fat dairy products are rich in saturated fat, these dietary guidelines recommend consumption of fat-free or low-fat dairy products in place of full-fat dairy. However, dairy products vary greatly in both their nutrient content and their bioactive ingredients, and research increasingly highlights the importance of focusing on whole foods (i.e., the food matrix) as opposed to single nutrients, such as saturated fat. In fact, the weight of evidence from recent large and well-controlled studies, systematic reviews, and meta-analyses of both observational studies and randomized controlled trials indicates that full-fat dairy products, particularly yogurt and cheese, do not exert the detrimental effects on insulin sensitivity, blood lipid profile, and blood pressure as previously predicted on the basis of their sodium and saturated fat contents; they do not increase cardiometabolic disease risk and may in fact protect against cardiovascular disease and type 2 diabetes. Although more research is warranted to adjust for possible confounding factors and to better understand the mechanisms of action of dairy products on health outcomes, it becomes increasingly clear that the recommendation to restrict dietary saturated fat to reduce risk of cardiometabolic disease is getting outdated. Therefore, the suggestion to restrict or eliminate full-fat dairy from the diet may not be the optimal strategy for reducing cardiometabolic disease risk and should be re-evaluated in light of recent evidence.

Impact of maternal education on response to lifestyle interventions to reduce gestational weight gain: individual participant data meta-analysis.

OBJECTIVES: To identify if maternal educational attainment is a prognostic factor for gestational weight gain (GWG), and to determine the differential effects of lifestyle interventions (diet based, physical activity based or mixed approach) on GWG, stratified by educational attainment. DESIGN: Individual participant data meta-analysis using the previously established International Weight Management in Pregnancy (i-WIP) Collaborative Group database (https://iwipgroup.wixsite.com/collaboration). Preferred Reporting Items for Systematic reviews and Meta-Analysis of Individual Participant Data Statement guidelines were followed. DATA SOURCES: Major electronic databases, from inception to February 2017. ELIGIBILITY CRITERIA: Randomised controlled trials on diet and physical activity-based interventions in pregnancy. Maternal educational attainment was required for inclusion and was categorised as higher education (≥tertiary) or lower education (≤secondary). RISK OF BIAS: Cochrane risk of bias tool was used. DATA SYNTHESIS: Principle measures of effect were OR and regression coefficient. RESULTS: Of the 36 randomised controlled trials in the i-WIP database, 21 trials and 5183 pregnant women were included. Women with lower educational attainment had an increased risk of excessive (OR 1.182; 95% CI 1.008 to 1.385, p =0.039) and inadequate weight gain (OR 1.284; 95% CI 1.045 to 1.577, p =0.017). Among women with lower education, diet basedinterventions reduced risk of excessive weight gain (OR 0.515; 95% CI 0.339 to 0.785, p = 0.002) and inadequate weight gain (OR 0.504; 95% CI 0.288 to 0.884, p=0.017), and reduced kg/week gain (B -0.055; 95% CI -0.098 to -0.012, p=0.012). Mixed interventions reduced risk of excessive weight gain for women with lower education (OR 0.735; 95% CI 0.561 to 0.963, p=0.026). Among women with high education, diet based interventions reduced risk of excessive weight gain (OR 0.609; 95% CI 0.437 to 0.849, p=0.003), and mixed interventions reduced kg/week gain (B -0.053; 95% CI -0.069 to -0.037,p<0.001). Physical activity based interventions did not impact GWG when stratified by education. CONCLUSIONS: Pregnant women with lower education are at an increased risk of excessive and inadequate GWG. Diet based interventions seem the most appropriate choice for these women, and additional support through mixed interventions may also be beneficial.

Effect of low energy diet for eight weeks to adults with overweight or obesity on folate, retinol, vitamin B12, D and E status and the degree of inflammation: a post hoc analysis of a randomized intervention trial.

BACKGROUND: Obesity is associated with vitamin insufficiency and low grade inflammation. The purpose of this study was to investigate the effect of weight loss on folate, retinol, vitamin B12, D and E status and the degree of inflammation. METHODS: Out of 110, 85 individuals (75% women) aged 39 ± 11 years with a mean ± SD BMI of 33 ± 4 kg/m2, completed an eight-week low energy diet (LED). Serum concentration of folate, retinol, B12, D and E and C-reactive protein and homocysteine (Hcy) were measured at baseline and at end of the LED. RESULTS: At baseline, 8% of the participants were deficient in folate, 13% in vitamin B12, 2% in retinol, 28% in vitamin D (72% were insufficient in vitamin D), and none were deficient in vitamin E. At baseline, BMI was inversely associated with retinol (P < 0.05) as was total and abdominal fat percentage with folate (P < 0.05); further BMI and measures of adiposity were positively associated with CRP (P < 0.01) and Hcy (P < 0.05). Homocysteine was inversely associated with all vitamins but retinol (P < 0.001). After the LED, the participants lost a mean [95% confidence intervals] of 12.3 [- 13.1,-11.6] kg. The serum concentration of folate, vitamin B12 and D were increased (P < 0.001) after the LED whereas the concentration of retinol and vitamin E were reduced (P < 0.001). CONCLUSION: Eight-weeks LED resulted in 13% weight loss and an increase in the serum concentrations of folate, vitamin B12 and D. Baseline adiposity was inversely associated with folate and retinol, and positively associated with markers of inflammation. TRIAL REGISTRATION: Ethical Committee of Copenhagen as no. H-4-2013-135, NCT01561131.

The efficacy of a high protein/low glycemic index diet intervention in non-obese patients with asthma.

BACKGROUND/OBJECTIVES: EFFORT Asthma study is a randomized controlled trial designed to assess the effects of diet and exercise in non-obese, untrained patients with asthma. We here present results from a subgroup of participants in the diet and control group to assess the feasibility of a high protein and low glycemic index (GI) diet and the effects on body composition. SUBJECTS/METHODS: Of the 149 subjects who were included in the study, 76 subjects (30 males) were randomized into either a diet group (n = 38) or a control group (n = 38) and included in the present analysis. The 8 week intervention consisted of a high protein and low GI diet whilst the control group continued habitual diet. RESULTS: Thirty-three patients in the diet and 34 in the control group completed the study. The diet group reduced their energy intake by ~20% and had high dietary compliance. Intake of fatty fish doubled and GI was reduced by 8.4 units. The diet group reduced their weight by 2.3 ± 2.2 kg vs. 0.5 ± 1.8 (p < 0.001), fat mass by 2.2 ± 2.0 kg vs. 0.3 ± 1.6 kg (p < 0.001) and preserved lean body mass (-0.02 ± 1.1 kg). The control group had no changes in body composition. CONCLUSIONS: The ad libitum high protein-low GI diet resulted in a greater loss of fat mass among non-obese patients with asthma. The subjects were satisfactory and highly compliant with the dietary regimen.

Effects of Exercise and Diet in Nonobese Asthma Patients-A Randomized Controlled Trial.

BACKGROUND: Behavioral interventions focusing on exercise and healthy diet improve asthma control in obese patients with asthma, but whether these interventions can lead to improvements in nonobese patients remains unclear. OBJECTIVES: In a randomized, controlled parallel-group design, we studied the effects of an 8-week intervention of either exercise (high-intensity interval training), diet (high protein/low glycemic index), or a combination of the 2, on asthma control and clinical outcomes in nonobese patients with asthma. METHODS: Nonobese adult patients with asthma (n = 149) were randomized to 1 of 4 groups: an exercise group, a diet group, an exercise + diet group, or a control group. Outcomes included Asthma Control Questionnaire (ACQ) score, asthma-related quality-of-life (Asthma-Related Quality-of-Life Questionnaire [AQLQ]) score, inflammatory cell counts in induced sputum, FEV1, fractional exhaled nitric oxide, and airway hyperresponsiveness (AHR). RESULTS: A total of 125 patients completed the study and were included in the data analysis. Patients in the exercise + diet group improved the ACQ score from 1.9 ± 0.7 to 1.0 ± 0.7 and the AQLQ score from 5.2 ± 0.8 to 6.2 ± 0.7, which was statistically significant when compared with changes in the control group (P < .05 and <.01, respectively). The exercise group and the diet group did not improve either the ACQ score or the AQLQ score significantly compared with the control group and there were no significant changes in sputum cell counts, FEV1, fractional exhaled nitric oxide, or AHR within any groups following the intervention period. CONCLUSIONS: The combination of exercise and diet improves asthma control in nonobese patients, but does not affect AHR or airway inflammation.

Effects of antenatal diet and physical activity on maternal and fetal outcomes: individual patient data meta-analysis and health economic evaluation.

BACKGROUND: Diet- and physical activity-based interventions in pregnancy have the potential to alter maternal and child outcomes. OBJECTIVES: To assess whether or not the effects of diet and lifestyle interventions vary in subgroups of women, based on maternal body mass index (BMI), age, parity, Caucasian ethnicity and underlying medical condition(s), by undertaking an individual patient data (IPD) meta-analysis. We also evaluated the association of gestational weight gain (GWG) with adverse pregnancy outcomes and assessed the cost-effectiveness of the interventions. DATA SOURCES: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects and Health Technology Assessment database were searched from October 2013 to March 2015 (to update a previous search). REVIEW METHODS: Researchers from the International Weight Management in Pregnancy Collaborative Network shared the primary data. For each intervention type and outcome, we performed a two-step IPD random-effects meta-analysis, for all women (except underweight) combined and for each subgroup of interest, to obtain summary estimates of effects and 95% confidence intervals (CIs), and synthesised the differences in effects between subgroups. In the first stage, we fitted a linear regression adjusted for baseline (for continuous outcomes) or a logistic regression model (for binary outcomes) in each study separately; estimates were combined across studies using random-effects meta-analysis models. We quantified the relationship between weight gain and complications, and undertook a decision-analytic model-based economic evaluation to assess the cost-effectiveness of the interventions. RESULTS: Diet and lifestyle interventions reduced GWG by an average of 0.70 kg (95% CI -0.92 to -0.48 kg; 33 studies, 9320 women). The effects on composite maternal outcome [summary odds ratio (OR) 0.90, 95% CI 0.79 to 1.03; 24 studies, 8852 women] and composite fetal/neonatal outcome (summary OR 0.94, 95% CI 0.83 to 1.08; 18 studies, 7981 women) were not significant. The effect did not vary with baseline BMI, age, ethnicity, parity or underlying medical conditions for GWG, and composite maternal and fetal outcomes. Lifestyle interventions reduce Caesarean sections (OR 0.91, 95% CI 0.83 to 0.99), but not other individual maternal outcomes such as gestational diabetes mellitus (OR 0.89, 95% CI 0.72 to 1.10), pre-eclampsia or pregnancy-induced hypertension (OR 0.95, 95% CI 0.78 to 1.16) and preterm birth (OR 0.94, 95% CI 0.78 to 1.13). There was no significant effect on fetal outcomes. The interventions were not cost-effective. GWG, including adherence to the Institute of Medicine-recommended targets, was not associated with a reduction in complications. Predictors of GWG were maternal age (summary estimate -0.10 kg, 95% CI -0.14 to -0.06 kg) and multiparity (summary estimate -0.73 kg, 95% CI -1.24 to -0.23 kg). LIMITATIONS: The findings were limited by the lack of standardisation in the components of intervention, residual heterogeneity in effects across studies for most analyses and the unavailability of IPD in some studies. CONCLUSION: Diet and lifestyle interventions in pregnancy are clinically effective in reducing GWG irrespective of risk factors, with no effects on composite maternal and fetal outcomes. FUTURE WORK: The differential effects of lifestyle interventions on individual pregnancy outcomes need evaluation. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003804. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

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.