Design and methodology of the impact of HemoDiaFIlTration on physical activity and self-reported outcomes: a randomized controlled trial (HDFIT trial) in Brazil.
BMC nephrology. 2019;(1):98
BACKGROUND End stage renal disease (ESRD) patients require a renal replacement therapy (RRT) to filter accumulated toxins and remove excess water, which are associated with impaired physical function. Hemodialysis (HD) removes middle-molecular weight (MMW) toxins less efficiently compared to hemodiafiltration (HDF); we hypothesized HDF may improve physical function. We detailed the design and methodology of the HDFIT protocol that is testing whether changing from HD to HDF effects physical activity levels and various outcomes. METHODS HDFIT is a prospective, multi-center, unblinded, randomized control trial (RCT) investigating the impact of dialysis modality (HDF verses HD) on objectively measured physical activity levels, self-reported quality of life, and clinical/non-clinical outcomes. Clinically stable patients with HD vintage of 3 to 24 months without any severe limitation ambulation were recruited from sites throughout southern Brazil. Eligible patients were randomized in a 1:1 ratio to either: 1) be treated with high volume online HDF for 6 months, or 2) continue being treated with high-flux HD. This study includes run-in and randomization visits (baseline), 3- and 6-month study visits during the interventional period, and a 12-month observational follow up. The primary outcome is the difference in the change in steps per 24 h on dialysis days from baseline to the 6-month follow up in patients treated with HDF versus HD. Physical activity is being measured over one week at study visits with the ActiGraph ( www.actigraphcorp.com ). For assessment of peridialytic differences during the dialysis recovery period, we will analyze granular physical activity levels based on the initiation time of HD on dialysis days, or concurrent times on non-dialysis days and the long interdialytic day. DISCUSSION In this manuscript, we provide detailed information about the HDFIT study design and methodology. This trial will provide novel insights into peridialytic profiles of physical activity and various self-reported, clinical and laboratory outcomes in ESRD patients treated by high volume online HDF versus high-flux HD. Ultimately, this investigation will elucidate whether HDF is associated with patients having better vitality and quality of life, and less negative outcomes as compared to HD. TRIAL REGISTRATION Registered on ClinicalTrials.gov on 20 April 2016 ( NCT02787161 ).
Dietary fiber intake and reduced risk of ovarian cancer: a meta-analysis.
Nutrition journal. 2018;17(1):99
Plain language summary
Dietary factors, including glycaemic load, fat, phytoestrogen, fruit and vegetable intake, play an important role in the development of ovarian cancer. The aim of this meta-analysis was to examine: 1. The available evidence from epidemiological studies; 2. The differences of ovarian cancer risk reported according to study design, geographic location and types or sources of fibre; 3) A possible dose-response relationship between dietary fibre intake and risk of ovarian cancer. 13 studies, comprising 5,777 ovarian cancer cases and 142,189 participants, published between 1994 and 2015, were included in this meta-analysis. All studies measured dietary intakes using a food-frequency questionnaire. The meta-analysis showed that the women with the highest intake of total fibre had a significantly lower risk (22%) of developing ovarian cancer than those with the lowest fibre intake, and that there was a dose dependent reduction in risk, for every 10g of fibre consumed, there was a 12% reduction in risk. When looking at different types/sources of fibre, vegetable fibre showed the biggest protective effect, whilst cereal fibres showed an increased risk for ovarian cancer. Factors which influenced the risk were contraceptive use and menopausal status. The authors discuss possible mechanisms for the protective effect of fibre: 1. Decrease of circulating oestrogen through changing of bacterial composition in the gut and 2. Reduction of glycaemic load through fibre.
BACKGROUND Epidemiological studies regarding the association between dietary fiber intake and ovarian cancer risk are still inconsistent. We aimed to review the available evidence and conduct a dose-response meta-analysis to investigate the relationship between dietary fiber intake and ovarian cancer risk. METHODS Relevant studies were identified by searching PubMed, EMBASE, and the Cochrane Library databases before August 2017. Studies that reported relative risk (RR) estimates with 95% confidence intervals (CIs) for the association between dietary fiber intake and risk of ovarian cancer were included. Random-effects models were used to combine the estimated effects extracted from individual study. RESULTS Thirteen studies, with a total of 5777 ovarian cancer cases and 142,189 participants, met the inclusion criteria. The pooled multivariable RRs of ovarian cancer for the highest vs. the lowest category of dietary fiber intake was 0.78 (95% CI: 0.70, 0.88) with no evidence of heterogeneity (I = 4.20%, P = 0.40). Our dose-response analysis also showed a significant inverse association between dietary fiber intake and ovarian cancer risk (an increment of 10 g/day; combined RR: 0.88; 95% CI: 0.82, 0.93). There was no evidence for a nonlinear association (P for nonlinearity = 0.83). CONCLUSIONS This meta-analysis suggests a significant inverse dose-response association between dietary fiber intake and ovarian cancer risk. Further studies with prospective design that take account of more potential confounders are warranted to confirm this association.
Significant improvement in cardiometabolic health in healthy nonobese individuals during caloric restriction-induced weight loss and weight loss maintenance.
American journal of physiology. Endocrinology and metabolism. 2018;(4):E396-E405
Calorie restriction (CR) triggers benefits for healthspan including decreased risk of cardiometabolic disease (CVD). In an ancillary study to CALERIE 2, a 24-mo 25% CR study, we assessed the cardiometabolic effects of CR in 53 healthy, nonobese (BMI: 22-28 kg/m2) men ( n = 17) and women ( n = 36). The aim of this study was to investigate whether CR can reduce risk factors for CVD and insulin resistance in nonobese humans and, moreover, to assess whether improvements are exclusive to a period of weight loss or continue during weight maintenance. According to the energy balance method, the 25% CR intervention ( n = 34) produced 16.5 ± 1.5% (mean ± SE) and 14.8 ± 1.5% CR after 12 and 24 mo (M12, M24), resulting in significant weight loss (M12 -9 ± 0.5 kg, M24 -9 ± 0.5 kg, P < 0.001). Weight was maintained in the group that continued their habitual diet ad libitum (AL, n = 19). In comparison to AL, 24 mo of CR decreased visceral (-0.5 ± 0.01 kg, P < 0.0001) and subcutaneous abdominal adipose tissue (-1.9 ± 0.2kg, P < 0.001) as well as intramyocellular lipid content (-0.11 ± 0.05%, P = 0.031). Furthermore, CR decreased blood pressure (SBP -8 ± 3 mmHg, P = 0.005; DBP -6 ± 2 mmHg, P < 0.001), total cholesterol (-13.6 ± 5.3 mg/dl, P = 0.001), and LDL-cholesterol (-12.9 ± 4.4 mg/dl, P = 0.005), and the 10-yr risk of CVD-disease was reduced by 30%. Homeostasis model assessment of insulin resistance (HOMA-IR) decreased during weight loss in the CR group (-0.46 ± 0.15, P = 0.003), but this decrease was not maintained during weight maintenance (-0.11 ± 0.15, P = 0.458). In conclusion, sustained CR in healthy, nonobese individuals is beneficial in improving risk factors for cardiovascular and metabolic disease such as visceral adipose tissue mass, ectopic lipid accumulation, blood pressure, and lipid profile, whereas improvements in insulin sensitivity were only transient.
Efficacy of SmartLoss, a smartphone-based weight loss intervention: results from a randomized controlled trial.
Obesity (Silver Spring, Md.). 2015;(5):935-42
OBJECTIVE Test the efficacy of SmartLoss, a smartphone-based weight loss intervention, in a pilot study. DESIGN AND METHODS A 12-week randomized controlled trial. Adults (25 ≤ BMI ≤ 35 kg/m2) were randomized to SmartLoss (n = 20) or an attention-matched Health Education control group (n = 20). SmartLoss participants were prescribed a 1,200 to 1,400 kcal/d diet and were provided with a smartphone, body weight scale, and accelerometer that wirelessly transmitted body weight and step data to a website. In the SmartLoss Group, mathematical models were used to quantify dietary adherence based on body weight and counselors remotely delivered treatment recommendations based on these objective data. The Health Education group received health tips via smartphone. A mixed model determined if change in weight and other endpoints differed between the groups (baseline was a covariate). RESULTS The sample was 82.5% female. Mean ± SD baseline age, weight (kg), and BMI were 44.4 ± 11.8 years, 80.3 ± 11.5 kg, and 29.8 ± 2.9 kg/m2, respectively. One participant was lost to follow-up in each group before week 4. Weight loss was significantly (P < 0.001) larger in the SmartLoss (least squares mean ± SEM: -9.4 ± 0.5%) compared with the Health Education group (-0.6 ± 0.5%). CONCLUSIONS SmartLoss efficaciously promote clinically meaningful weight loss compared with an attention-matched control group. Smartphone-based interventions might prove useful in intervention dissemination.
The role of meal viscosity and oat β-glucan characteristics in human appetite control: a randomized crossover trial.
Nutrition journal. 2014;:49
BACKGROUND Foods that enhance satiety can help consumers to resist environmental cues to eat, and improve the nutritional quality of their diets. Viscosity generated by oat β-glucan, influences gastrointestinal mechanisms that mediate satiety. Differences in the source, processing treatments, and interactions with other constituents in the food matrix affect the amount, solubility, molecular weight, and structure of the β-glucan in products, which in turn influences the viscosity. This study examined the effect of two types of oatmeal and an oat-based ready-to-eat breakfast cereal (RTEC) on appetite, and assessed differences in meal viscosity and β-glucan characteristics among the cereals. METHODS Forty-eight individuals were enrolled in a randomized crossover trial. Subjects consumed isocaloric breakfast meals containing instant oatmeal (IO), old-fashioned oatmeal (SO) or RTEC in random order at least a week apart. Each breakfast meal contained 218 kcal (150 kcal cereal, and 68 kcal milk) Visual analogue scales measuring appetite were completed before breakfast, and over four hours, following the meal. Starch digestion kinetics, meal viscosities, and β-glucan characteristics for each meal were determined. Appetite responses were analyzed by area under the curve. Mixed models were used to analyze response changes over time. RESULTS IO increased fullness (p = 0.04), suppressed desire to eat (p = 0.01) and reduced prospective intake (p < 0.01) more than the RTEC over four hours, and consistently at the 60 minute time-point. SO reduced prospective intake (p = 0.04) more than the RTEC. Hunger scores were not significantly different except that IO reduced hunger more than the RTEC at the 60 minute time-point. IO and SO had higher β-glucan content, molecular weight, gastric viscosity, and larger hydration spheres than the RTEC, and IO had greater viscosity after oral and initial gastric digestion (initial viscosity) than the RTEC. CONCLUSION IO and SO improved appetite control over four hours compared to RTEC. Initial viscosity of oatmeal may be especially important for reducing appetite.
Effects of weight gain induced by controlled overfeeding on physical activity.
American journal of physiology. Endocrinology and metabolism. 2014;(11):E1030-7
It is unclear whether physical activity changes following long-term overfeeding and in response to different dietary protein intakes. Twenty-five (16 males, 9 females) healthy adults (18-35 yr) with BMI ranging from 19 to 30 kg/m(2) enrolled in this inpatient study. In a parallel group design, participants were fed 140% of energy needs, with 5, 15, or 25% of energy from protein, for 56 days. Participants wore an RT3 accelerometer for at least 59 days throughout baseline and during overfeeding and completed 24-h whole room metabolic chamber assessments at baseline and on days 1, 14, and 56 of overfeeding and on day 57, when the baseline energy intake was consumed, to measure percent of time active and spontaneous physical activity (SPA; kcal/day). Changes in activity were also assessed by doubly labeled water (DLW). From accelerometry, vector magnitude (VM), a weight-independent measure of activity, and activity energy expenditure (AEE) increased with weight gain during overfeeding. AEE remained increased after adjusting for changes in body composition. Activity-related energy expenditure (AREE) from DLW and percent activity and SPA in the metabolic chamber increased with overfeeding, but SPA was no longer significant after adjusting for change in body composition. Change in VM and AEE were positively correlated with weight gain; however, change in activity was not affected by protein intake. Overfeeding produces an increase in physical activity and in energy expended in physical activity after adjusting for changes in body composition, suggesting that increased activity in response to weight gain might be one mechanism to support adaptive thermogenesis.
Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial.
Obesity (Silver Spring, Md.). 2012;(8):1653-61
This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group, in all participants and in overweight children. The Louisiana (LA) Health study utilized a longitudinal, cluster randomized three-arm controlled design, with 28 months of follow-up. Children (N = 2,060; mean age = 10.5 years, SD = 1.2) from rural communities in grades 4-6 participated in the study. Seventeen school clusters (mean = 123 children/cluster) were randomly assigned to one of three prevention arms: (i) primary prevention (PP), an environmental modification (EM) program, (ii) primary + secondary prevention (PP+SP), the environmental program with an added classroom and internet education component, or (iii) control (C). Primary outcomes were changes in percent body fat and BMI z scores. Secondary outcomes were changes in behaviors related to energy balance. Comparisons of PP, PP+SP, and C on changes in body fat and BMI z scores found no differences. PP and PP+SP study arms were combined to create an EM arm. Relative to C, EM decreased body fat for boys (-1.7 ± 0.38% vs. -0.14 ± 0.69%) and attenuated fat gain for girls (2.9 ± 0.22% vs. 3.93 ± 0.37%), but standardized effect sizes were relatively small (<0.30). In conclusion, this school-based EM programs had modest beneficial effects on changes in percent body fat. Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention, but did impact physical activity and social support in overweight children.
Corrosive induced carcinoma of esophagus after 58 years.
The Annals of thoracic surgery. 2012;(6):2103-5
Patients with corrosive induced esophageal strictures have an increased risk of esophageal carcinoma. We present a case of a 61-year-old man who ingested sulfuric acid at the age of 3 years and then developed dysphagia at late follow-up. In 2010, he presented to the outpatient clinic with weight loss and worsening dysphagia to both solids and liquids. A barium swallow radiograph and endoscopy demonstrated a long stricture in the middle third of the esophagus. Ivor-Lewis esophagectomy was undertaken via an upper midline abdominal incision and a right thoracotomy, and pathologic examination of the resection specimen confirmed a well-differentiated esophageal squamous cell carcinoma. Twenty-two months postoperatively, he reports no dysphagia, and no tumor recurrence was evident during follow-up.
Body image changes associated with participation in an intensive lifestyle weight loss intervention.
Obesity (Silver Spring, Md.). 2011;(6):1290-5
The primary aim of this study was to test for changes in body image in men and women enrolled in the Look AHEAD trial. Look AHEAD (Action for Health in Diabetes) is a multicenter, randomized controlled trial designed to test whether intentional weight loss reduces cardiovascular morbidity and mortality in overweight individuals with type 2 diabetes. Participants included 157 adults at one site (Pennington Biomedical Research Center (PBRC), Baton Rouge, LA) of the Look AHEAD study. At baseline, the mean BMI of the female participants was 36.4, and the mean BMI for males was 33.5. Following baseline assessment, participants were randomly assigned to the intensive lifestyle intervention (ILI, n = 81) or diabetes support and education (DSE, n = 76). The body morph assessment version 2.0 (BMA 2.0) was used to assess estimates of perceived current body size, ideal body size, acceptable body size, and body image dissatisfaction at baseline and 1 year. Over the 1 year, participants in the ILI group had significantly greater reductions in weight (10.1% for men and 8.9% for women) than those in the DSE group (+ 0.8% for men and -0.2%, for women). Perceived current body size was reduced significantly more in both men and women in the ILI group, relative to DSE. There were also significantly greater reductions in body image dissatisfaction in the ILI group, relative to the DSE group for men and women. The results of this study indicate that body image dissatisfaction improved following participation in an intensive behavioral weight loss program.
H.E.A.L.T.H.: efficacy of an internet/population-based behavioral weight management program for the U.S. Army.
Journal of diabetes science and technology. 2011;(1):178-87
BACKGROUND A significant number of soldiers exceed the maximum allowable weight standards or have body weights approaching the maximum allowable weight standards. This mandates development of scalable approaches to improve compliance with military weight standards. METHODS We developed an intervention that included two components: (1) an Internet-based weight management program (Web site) and (2) a promotion program designed to promote and sustain usage of the Web site. The Web site remained online for 37 months, with the Web site promotion program ending after 25 months. RESULTS Soldiers' demographics were as follows: mean age, 32 years; body mass index (BMI), 28 kg/m²; 31% female; and 58% Caucasian. Civilian demographics were as follows: mean age, 38 years; BMI, 30 kg/m²; 84% female; and 55% Caucasian. Results indicated that 2417 soldiers and 2147 civilians (N = 4564) registered on the Web site. In the first 25 months (phase 1) of the study, new participants enrolled on the Web site at a rate of 88 (soldiers) and 80 (civilians) per month. After the promotion program was removed (phase 2), new participants enrolled at a rate of 18 (soldiers) and 13 (civilians) per month. Utilization of the Web site was associated with self-reported weight loss (p < .0001). Participants who utilized the Web site more frequently lost more weight (p < .0001). Participants reported satisfaction with the Web site. CONCLUSIONS The Web site and accompanying promotion program, when implemented at a military base, received satisfactory ratings and benefited a subset of participants in promoting weight loss. This justifies further examination of effectiveness in a randomized trial setting.