947 resultados para single blind procedure


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The addition of some legume ingredients to bread has been associated with effects on glycaemic, insulinaemic and satiety responses that may be beneficial in controlling type 2 diabetes, cardiovascular disease and obesity. However, the effect of Australian sweet lupin (Lupinus angustifolius) flour (ASLF) is unknown. This investigation examined the effect of adding ASLF to standard white bread on post-meal glycaemic, insulinaemic and satiety responses and palatability in healthy subjects. Using a randomised, single-blind, cross-over design, 11 subjects consumed one breakfast of ASLF bread and two of standard white bread ≥ 7 days apart after fasting overnight. Each breakfast also included margarine, jam, and tea with milk and contained 50g available carbohydrate. On each test day, blood samples were taken after fasting, then several times over 2 hours post-prandially, and analysed for plasma glucose and serum insulin. Subjects rated breakfast palatability and perception of satiety, in the fasting state and over 3 hours post-prandially, after which food intake from an ad libitum buffet and for the rest of the day was recorded. Incremental areas under the curves for glucose, insulin and satiety, glycaemic index, insulinaemic index and satiety index were calculated. ASLF addition to the breakfast reduced its glycaemic index (mean ± SEM; ASLF bread breakfast = 74.0 ± 9.6. Standard white bread breakfast = 100, P=0.022), raised its insulinaemic index (ASLF bread breakfast = 127.7 ± 12.0. Standard white bread breakfast = 100, P=0.046), but did not affect palatability, satiety or food intake. ASLF addition resulted in a palatable breakfast; however, the potential benefits of the lowered glycaemic index may be eclipsed by the increased insulinaemic index.

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Objective: To determine the effect of adding chickpea flour or extruded chickpea flour to white bread on palatability and postprandial glycaemia, insulinaemia and satiety.

Design: A randomised, single-blind, cross-over study of four 50 g available carbohydrate breakfasts.

Setting: School of Exercise and Nutrition Sciences, Deakin University.

Subjects: In all, 12 healthy subjects were recruited through posted notices. Totally, 11 (nine male, two female) completed the study (meanplusminuss.e.m.; age 32±2 y; body mass index, 24.7±0.8 kg/m2).

Intervention: After overnight fasting, subjects consumed a control (white) bread (WB) breakfast twice, a chickpea bread (CHB) breakfast once and an extruded chickpea bread (EXB) breakfast once. Palatability and postprandial blood glucose, insulin and satiety responses were determined. Following this, food intakes from an ad libitum buffet and for the remainder of the day were assessed.

Results: A trend towards a lower incremental area under the curve (IAUC) of glucose for the CHB breakfast compared to the WB breakfast was observed (P=0.087). The IAUC of insulin and insulinaemic index (II) of the CHB breakfast were higher (P<0.05) than for the WB breakfast. No differences in glycaemic index (GI), satiety response, food intake or palatability were observed.

Conclusions: CHB and EXB demonstrated acceptable palatability. CHB demonstrated some hypoglycaemic effect compared to WB, but neither CHB nor EXB demonstrated effects on satiety or food intake. The hyperinsulinaemic effect of CHB observed in this study requires further investigation.

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Background Changes in the composition of gastrointestinal microbiota by dietary interventions using pro- and prebiotics provide opportunity for improving health and preventing disease. However, the capacity of lupin kernel fiber (LKFibre), a novel legume-derived food ingredient, to act as a prebiotic and modulate the colonic microbiota in humans needed investigation.

Aim of the study The present study aimed to determine the effect of LKFibre on human intestinal microbiota by quantitative fluorescent in situ hybridization (FISH) analysis.

Design A total of 18 free-living healthy males between the ages of 24 and 64 years consumed a control diet and a LKFibre diet (containing an additional 17–30 g/day fiber beyond that of the control—incorporated into daily food items) for 28 days with a 28-day washout period in a single-blind, randomized, crossover dietary intervention design.
Methods Fecal samples were collected for 3 days towards the end of each diet and microbial populations analyzed by FISH analysis using 16S rRNA gene-based oligonucleotide probes targeting total and predominant microbial populations.

Results Significantly higher levels of Bifidobacterium spp. (P = 0.001) and significantly lower levels of the clostridia group of C. ramosum, C. spiroforme and C. cocleatum (P = 0.039) were observed on the LKFibre diet compared with the control. No significant differences between the LKFibre and the control diet were observed for total bacteria, Lactobacillus spp., the Eubacterium spp., the C. histolyticum/C. lituseburense group and the Bacteroides–Prevotella group.
Conclusions Ingestion of LKFibre stimulated colonic bifidobacteria growth, which suggests that this dietary fiber may be considered as a prebiotic and may beneficially contribute to colon health.

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Consumption of some dietary fibres may benefit bowel health; however, the effect of Australian sweet lupin (Lupinus angustifolius) kernel fibre (LKFibre) is unknown. The present study examined the effect of a high-fibre diet containing LKFibre on bowel function and faecal putative risk factors for colon cancer compared to a control diet without LKFibre. Thirty-eight free-living, healthy men consumed an LKFibre and a control diet for 1 month each in a single-blind, randomized, crossover study. Depending on subject energy intake, the LKFibre diet was designed to provide 17–30 g/d fibre (in experimental foods) above that of the control diet. Bowel function self-perception, frequency of defecation, transit time, faecal output, pH and moisture, faecal levels of SCFA and ammonia, and faecal bacterial [ß]-glucuronidase activity were assessed. In comparison to the control diet, the LKFibre diet increased frequency of defecation by 0·13 events/d (P = 0·047), increased faecal output by 21 % (P = 0·020) and increased faecal moisture content by 1·6 % units (P = 0·027), whilst decreasing transit time by 17 % (P = 0·012) and decreasing faecal pH by 0·26 units (P < 0·001). Faecal butyrate concentration was increased by 16 % (P = 0·006), butyrate output was increased by 40 % (P = 0·002) and [ß]-glucuronidase activity was lowered by 1·4 µmol/h per g wet faeces compared to the control diet (P < 0·001). Addition of LKFibre to the diet incorporated into food products improved some markers of healthy bowel function and colon cancer risk in men.

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Combining exercise with calcium supplementation may produce additive or multiplicative effects at loaded sites; thus, we conducted a single blind, prospective, randomized controlled study in pre- and early-pubertal girls to test the following hypotheses. (1) At the loaded sites, exercise and calcium will produce greater benefits than exercise or calcium alone. (2) At non-loaded sites, exercise will have no benefit, whereas calcium with or without exercise will increase bone mass over that in exercise alone or no intervention. Sixty-six girls aged 8.8 ± 0.1 years were randomly assigned to one of four study groups: moderate-impact exercise with or without calcium or low-impact exercise with or without calcium. All participants exercised for 20 minutes, three times a week and received Ca-fortified (434 ± 19 mg/day) or non-fortified foods for 8.5 months. Analysis of covariance (ANCOVA) was used to determine interaction and main effects for exercise and calcium on bone mass after adjusting for baseline bone mineral content and growth in limb lengths. An exercise-calcium interaction was detected at the femur (7.1%, p < 0.05). In contrast, there was no exercise-calcium interaction detected at the tibia-fibula; however, there was a main effect of exercise: bone mineral content increased 3% more in the exercise than non-exercise groups (p < 0.05). Bone mineral content increased 2-4% more in the calcium-supplemented groups than the non-supplemented groups at the humerus (12.0% vs. 9.8%, respectively, p < 0.09) and radius-ulna (12.6% vs. 8.6%, respectively, p < 0.01). In conclusion, greater gains in bone mass at loaded sites may be achieved when short bouts of moderate exercise are combined with increased dietary calcium, the former conferring region-specific effects and the latter producing generalized effects.

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The age and developmental stage at which calcium supplementation produces the greatest bone effects remain controversial. We tested the hypothesis that calcium supplementation may improve bone accrual in premenarcheal females. Fifty-one pairs of premenarcheal female twins (27 monozygotic and 24 dizygotic; mean ± SD age, 10.3 ± 1.5 yr) participated in a randomized, single-blind, placebo-controlled trial with one twin of each pair receiving a 1200-mg calcium carbonate (Caltrate) supplement. Areal bone mineral density (aBMD) was measured at baseline and 6, 12, 18 and 24 months. There were no within-pair differences in height, weight, or calcium intake at baseline. Calcium supplementation was associated (P < 0.05) with increased aBMD compared with placebo, adjusted for age, height, and weight at the following time points from baseline: total hip, 6 months (1.9%), 12 months (1.6%), and 18 months (2.4%); lumbar spine, 12 months (1.0%); femoral neck, 6 months (1.9%). Adjusted total body bone mineral content was higher in the calcium group at 6 months (2.0%), 12 months (2.5%), 18 months (4.6%), and 24 months (3.7%), respectively (all P < 0.001). Calcium supplementation was effective in increasing aBMD at regional sites over the first 12–18 months, but these gains were not maintained to 24 months.

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Objectives: To determine the efficacy on plasma cholesterol-lowering of plant sterol esters or non-esterified stanols eaten within low-fat foods as well as margarine.
Design: Randomised, controlled, single-blind study with sterol esters and non-esterified plant stanols provided in breakfast cereal, bread and spreads. Study 1 comprised 12 weeks during which sterol esters (2.4 g) and stanol (2.4 g) -containing foods were eaten during 4 week test periods of cross-over design following a 4 week control food period. In Study 2, in a random order cross-over design, a 50% dairy fat spread with or without 2.4 g sterol esters daily was tested.
Subjects: Hypercholesterolaemic subjects; 22 in study 1 and 15 in study 2.
Main outcome measures: Plasma lipids, plasma sterols, plasma carotenoids and tocopherols.
Results: Study 1¾median LDL cholesterol was reduced by the sterol esters (-13.6%; P<0.001 by ANOVA on ranks; P<0.05 by pairwise comparison) and by stanols (-8.3%; P=0.003, ANOVA and <0.05 pairwise comparison). With sterol esters plasma plant sterol levels rose (35% for sitosterol, 51% for campesterol; P<0.001); plasma lathosterol rose 20% (P=0.03), indicating compensatory increased cholesterol synthesis. With stanols, plasma sitosterol fell 22% (P=0.004), indicating less cholesterol absorption. None of the four carotenoids measured in plasma changed significantly. In study 2, median LDL cholesterol rose 6.5% with dairy spread and fell 12.2% with the sitosterol ester fortified spread (P=0.03 ANOVA and <5% pairwise comparison).
Conclusion: 1. Plant sterol esters and non-esterified stanols, two-thirds of which were incorporated into low-fat foods, contributed effectively to LDL cholesterol lowering, extending the range of potential foods. 2. The LDL cholesterol-raising effect of butter fat could be countered by including sterol esters. 3. Plasma carotenoids and tocopherols were not reduced in this study.

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Several soluble polysaccharides have been shown to have cholesterol-lowering properties and to have a role in prevention of heart disease. Major sources of one such polysaccharide (beta-glucan) are oats and barley. The aim of this study was to examine the effects on plasma lipid concentrations when beta-glucan derived from a fractionated oat preparation was consumed by people with elevated plasma lipids. A single-blind, crossover design compared plasma cholesterol, triglycerides, high density lipoproteins and low density lipoproteins (LDLs) in 14 people; in the order of low, high and low beta-glucan supplemented diets, each of three weeks duration. For the high beta-glucan diet, an average intake of 7 g per day was consumed from cereal, muffins and bread. The background diet remained relatively constant over the three test periods. Differences during the interventions were calculated by one-way repeated measures analysis of variance. Where treatments were found to be significantly different, pairwise multiple comparison procedures (Tukey Test) were carried out between the high beta-glucan and each of the low beta-glucan phases and there was a highly significant difference between treatments for plasma cholesterol (P = 0.009) and for LDL-cholesterol concentrations (P < 0.001). The differences in plasma cholesterol (6.42 +/- 0.7, 6.14 +/- 0.53, 6.44 +/- 0.67 mmol/L) and LDL-cholesterol (4.59 +/- 0.59, 4.17 +/0.58, 4.52 +/- 0.65 mmol/L) between high beta-glucan and each of the low beta-glucan treatments were significant (P < 0.05). The effect on LDLs (9% lower) is among the highest reported. The results of this study confirm that beneficial reductions in plasma cholesterol and LDL-cholesterol concentrations can be obtained with beta-glucan incorporated into a variety of foods.

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Background and Aim:  Reduction of short-chain poorly absorbed carbohydrates (FODMAPs) in the diet reduces symptoms of irritable bowel syndrome (IBS). In the present study, we aimed to compare the patterns of breath hydrogen and methane and symptoms produced in response to diets that differed only in FODMAP content.
Methods:  Fifteen healthy subjects and 15 with IBS (Rome III criteria) undertook a single-blind, crossover intervention trial involving consuming provided diets that were either low (9 g/day) or high (50 g/day) in FODMAPs for 2 days. Food and gastrointestinal symptom diaries were kept and breath samples collected hourly over 14 h on day 2 of each diet.
Results:  Higher levels of breath hydrogen were produced over the entire day with the high FODMAP diet for healthy volunteers (181 ± 77 ppm.14 h vs 43 ± 18; mean ± SD P < 0.0001) and patients with IBS (242 ± 79 vs 62 ± 23; P < 0.0001), who had higher levels during each dietary period than the controls (P < 0.05). Breath methane, produced by 10 subjects within each group, was reduced with the high FODMAP intake in healthy subjects (47 ± 29 vs 109 ± 77; P = 0.043), but was not different in patients with IBS (126 ± 153 vs 86 ± 72). Gastrointestinal symptoms and lethargy were significantly induced by the high FODMAP diet in patients with IBS, while only increased flatus production was reported by healthy volunteers.
Conclusions:  Dietary FODMAPs induce prolonged hydrogen production in the intestine that is greater in IBS, influence the amount of methane produced, and induce gastrointestinal and systemic symptoms experienced by patients with IBS. The results offer mechanisms underlying the efficacy of the low FODMAP diet in IBS.

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Background:  Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the ‘holistic’ approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people.

Methods/design: A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed.

Discussion: This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting seniors recognises the heterogeneity of multicultural populations and may further increase the number of taking part in exercise.

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Background

Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation.

Methods

This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge.

Results

We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08).

Conclusions

Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. 

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PURPOSE: This study investigated the efficacy of an intermittent critical power model, termed the "work-balance" (W'BAL) model, during high-intensity exercise in hypoxia. METHODS: Eleven trained, male cyclists (mean ± SD; age 27 ± 6.6 yr, V[Combining Dot Above]O2peak 4.79 ± 0.56 L.min) completed a maximal ramp test and a 3 min "all-out" test to determine critical power (CP) and work performed above CP (W'). On another day an intermittent exercise test to task failure was performed. All procedures were performed in normoxia (NORM) and hypoxia (HYPO; FiO2 ≈ 0.155) in a single-blind, randomized and counter-balanced experimental design. The W'BAL model was used to calculate the minimum W' (W'BALmin) achieved during the intermittent test. W'BALmin in HYPO was also calculated using CP + W' derived in NORM (N+H). RESULTS: In HYPO there was an 18% decrease in V[Combining Dot Above]O2peak (4.79 ± 0.56 vs 3.93 ± 0.47 L.min ; P<0.001) and a 9% decrease in CP (347 ± 45 vs 316 ± 46 W; P<0.001). No significant change for W' occurred (13.4 ± 3.9 vs 13.7 ± 4.9 kJ; P=0.69; NORM vs HYPO). The change in V[Combining Dot Above]O2peak was significantly correlated with the change in CP (r = 0.72; P=0.01). There was no difference between NORM and HYPO for W'BALmin (1.1 ± 0.9 kJ vs 1.2 ± 0.6 kJ). The N+H analysis grossly overestimated W'BALmin (7.8 ± 3.4 kJ) compared with HYPO (P<0.001). CONCLUSION: The W'BAL model produced similar results in hypoxia and normoxia, but only when model parameters were determined under the same environmental conditions as the performance task. Application of the W'BAL model at altitude requires a modification of the model, or that CP and W' are measured at altitude.

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Many studies have been made to understand the process of tissular cicatrization, as well as the possible effects of laser therapy in the wound healing. However, the influence of low frequency laser irradiation in the repairing process is not completely understood. Our study has the purpose to assess clinically the effect of postoperative irradiation of the low frequency laser in humans, and the gingival repairing process postgingivoplasty performed with the extern bevel technique. Twenty-four patients with inflammatory gingival hyperplasia were enrolled in this study, which did not reduce with basic periodontal procedures, and patients with melanin pigmentation, with esthetic indications. After surgery the test group, randomly selected by a drawing, received laser application with energy density of 4 J/cm2, immediately after surgery and each 48 hours, during a week, with a total of 4 sections. The control group did not receive irradiation. The visual clinical analyses were performed by a single blind examiner, in the 2nd, 4th, 6th, 8th, 15th and 21st days post surgery. For statistic analyses of the data was used a Q-square test. Concerning the color, the results showed a better wound healing during days 6 to 8. when assessed the degree of progress of surgical wound, the results showed that the test group had a better cicatrization compared with the control group in the 2nd, 6th, 8th and 15th days post surgery, and at the 21st day both groups had the same results. Our results confirm that the laser had clinical influence in the repairing process after gingivoplasty surgery during days 2 to 15 post surgery

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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The objective of the present study was to evaluate the effects of double uterine flushing on the recovery of embryos/ova in cattle. Two hundred and ten embryo recovery procedures were conducted using a double uterine flushing method, and the results were compared with 432 conventional single-flushing procedures. Cyclic Limousin (n = 403) and Guzera (n = 239) donor cows received an intravaginal progesterone releasing device and 2 mg of estradiol benzoate on Day 0. Between Days 5 and 9, donors received decreasing doses of FSH, which ranged from 200 to 300 IU (Bos indicus) and 300 to 500 IU (Bos taut-us). on the afternoon of Day 7, donors received an injection of 500 mu g cloprostenol and progesterone implants were removed 12 It later (morning of Day 8). Artificial insemination was performed between 14 and 26 h after first detection of behavioral estrus. Cows were randomly assigned to have embryos recovered by a double-flushing method (n = 210) or the conventional single-flushing procedure (n = 432). For the double-flushing procedure, after first flushing the whole uterus with 1 L of Dubelco's Phosphate Buffered Saline (DPBS), a Foley catheter was positioned in the uterine body to permit refilling of the uterus with fresh DPBS (80-150 mL). The catheter was closed with the plunger of a disposable 5 mL syringe, and the donors were allowed to rest in a holding area for 30 min. Thereafter, a second flush was performed to recover the solution remaining in the uterus. Animals from the control group were subjected to a single uterine flush. From 2 10 double-flushing procedures, 1409 viable embryos were recovered. In comparison, from 432 cows receiving the single-flushing procedure, 1993 embryos were recovered. Double flushing increased (P < 0.05) the number of embryos recovered per procedure compared to single flushing (6.7 +/- 0.4 versus 4.6 +/- 0.2, respectively; mean +/- S.E.M.). When double flushing was performed, average recovered embryos/ova increased (P < 0.05) from 8.3 +/- 0.4 to 12.7 +/- 0.7 in Limousin and from 7.9 to 11.5 in Guzera. Also, utilization of double flushing increased (P < 0.05) the number of viable embryos from 4.7 +/- 0.3 to 6.9 +/- 0.5 in Limousin and from 4.5 +/- 0.4 to 6.4 +/- 0.7 in Guzera. Mean total embryos/ova was similar (P > 0.05) between the control group and after the first uterine flushing in the double-flushing group; therefore, both flushings were conducted efficiently. In conclusion, double uterine flushing increased embryo recovery in cattle. (C) 2004 Elsevier B.V. All rights reserved.