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Results for “randomized crossover trial”

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PubMed2006

The effect of insulin infusion upon protein metabolism in neonates on extracorporeal life support.

OBJECTIVE: Critically ill neonates on extracorporeal life support (ECLS) demonstrate elevated rates of protein breakdown that, in turn, are associated with increased morbidity and mortality. This study sought to determine if the administration of the anabolic hormone insulin improved net protein balance in neonates on ECLS. METHODS: Twelve parenterally fed neonates, on ECLS, were enrolled in a randomized, prospective, crossover trial. Subjects were administered a hyperinsulinemic euglycemic clamp and a control saline infusion. Protein metabolism was quantified using ring-D5-phenylyalanine and ring-D2-tyrosine stable isotopic infusions. Statistical comparisons were made by paired sample t tests (significance at P < 0.05). RESULTS: Serum insulin concentration increased 20-fold during insulin infusion compared with saline infusion control (P < 0.0001). Protein breakdown was significantly decreased during insulin infusion compared with controls (7.98 +/- 1.82 vs. 6.89 +/- 1.03 g/kg per day; P < 0.05). Serum amino acid concentrations were significantly decreased by insulin infusion (28,450 +/- 9270 vs. 20,830 +/- 8110 micromol/L; P < 0.02). Insulin administration tended to decrease protein synthesis (9.58 +/- 2.10 g/kg per day vs. 8.60 +/- 1.20; P = 0.05). For the whole cohort, insulin only slightly improved net protein balance (protein synthesis minus protein breakdown) (1.60 +/- 0.80 vs. 1.71 +/- 0.89 g/kg per day; P = 0.08). In neonates receiving > or =2 g/kg per day of dietary amino acids insulin significantly improved net protein balance (2.17 +/- 0.34 vs. 2.40 +/- 0.26 g/kg per day; P < 0.01). CONCLUSIONS: Insulin effectively decreases protein breakdown in critically ill neonates on ECLS. However, this is associated with a significant reduction in plasma amino acids and a trend toward decreased protein synthesis. Insulin administration significantly improves net protein balance only in those ECLS neonates in whom adequate dietary protein is provided.

Cross-Over Studies↗

PubMed2004

Comparison of a high-carbohydrate and a high-monounsaturated fat, olive oil-rich diet on the susceptibility of LDL to oxidative modification in subjects with Type 2 diabetes mellitus.

AIMS: To compare the effects of a high-carbohydrate (CHO) diet and a high-monounsaturated fatty acid (MUFA) diet on LDL oxidative resistance in free-living individuals with Type 2 diabetes mellitus. METHODS: Twenty-two men and women out-patients with Type 2 diabetes, with mean age 61 years and in fair metabolic control (HbA1c<8.0%), were enrolled at a university hospital lipid clinic in a randomized, crossover feeding trial comparing two isocaloric diets for 6 weeks each: CHO (fat, 28% energy) and MUFA (fat, 40% energy) based on virgin olive oil. Outcome measurements were changes in LDL susceptibility to oxidation, body weight, glycaemic control, and lipoprotein profiles. RESULTS: Planned and observed diets were well matched. Participants preferred the MUFA diet over the CHO diet. The lag time of conjugated diene formation during Cu2+-induced LDL oxidation was similar after the CHO and MUFA diets (36.4 +/- 12.2 min and 36.0 +/- 13.7 min, respectively). Body weight, glycaemic control, total triglycerides, and total, LDL- and HDL-cholesterol levels also were similar after the two diets. Compared with the CHO diet, the MUFA diet lowered VLDL-cholesterol by 35% (P=0.023) and VLDL triglyceride by 16% (P=0.016). CONCLUSIONS: Natural food-based high-CHO and high-MUFA diets have similar effects on LDL oxidative resistance and metabolic control in subjects with Type 2 diabetes. A MUFA diet is a good alternative to high-CHO diets for nutrition therapy of diabetes because it also has a beneficial effect on the lipid profile and superior patient acceptance.

Aged↗

PubMed2003

Evaluation of bioequivalence of isoniazid and pyrazinamide in three and four drugs fixed dose combinations using WHO simplified protocol.

The reliable supply of quality drugs in the form of fixed dose combination (FDC) is an essential part of tuberculosis treatment. The objective of this investigation was to evaluate whether the World Health Organization (WHO) simplified screening protocol for the bioequivalence assessment of rifampicin can be used for the evaluation of other components of FDC so as to ensure the bioavailability of all drugs at tissue site. These bioequivalence studies were conducted on 20 and 22 healthy male volunteers for evaluation of three and four drugs FDC formulations, respectively. Both studies were conducted as randomized, open, crossover trials and sampling schedule was upto 8h according to WHO recommended protocol for evaluation of rifampicin bioequivalence. The bioequivalence of isoniazid and pyrazinamide were estimated using AUC(0-8), AUC(0-alpha), and C(max). FDC formulation was considered bioequivalent to separate formulations for isoniazid and pyrazinamide if bioequivalence limit fall in between 0.80 and 1.25. Bioequivalence estimates of AUC(0-8) and AUC(0-alpha) for isoniazid and all the three pharmacokinetic measures of pyrazinamide were within the acceptable limits, whereas C(max) of isoniazid from four drugs FDC was outside the limit when evaluated by two-way ANOVA. After evaluation of isoniazid and pyrazinamide based on their pharmacokinetics, it was found that C(max) is being affected by limited sampling time points of WHO protocol. Further, AUC was a robust parameter unaffected by sampling schedule adopted. The WHO simplified protocol for assessment of rifampicin is also suitable for evaluating bioequivalence of isoniazid and pyrazinamide from FDC formulations. However, for comparison of rate of absorption by means of C(max), careful evaluation of concentration-time profile along with pharmacokinetics is necessary before final judgment.

Administration, Oral↗

PubMed1993

Effect of reduced alcohol consumption on blood pressure in untreated hypertensive men.

Fifty-four untreated, mildly hypertensive men whose daily alcohol consumption was > or = 28 ml ethanol and who drank at least 4 times per week took part in a randomized, controlled crossover trial. The purpose of the trial was to test the effects of alcohol reduction on blood pressure. After a 2-week familiarization period, the participants were assigned to either a reduced alcohol drinking group or a usual drinking group for 3 weeks (experimental period 1). The situation was then reversed for the next 3 weeks (experimental period 2). The participants were requested to limit their daily alcohol consumption to zero or reduce it as much as possible for the reduced alcohol consumption period. The self-reported alcohol consumption was 56.1 +/- 3.6 (SEM) ml/day during the usual alcohol drinking period and 26.1 +/- 3.0 ml/day during the period of reduced alcohol consumption. Systolic and diastolic blood pressures in the intervention group were found by analysis of variance to be significantly lower (2.6-4.8 and 2.2-3.0 mm Hg, respectively) than those in the control group during experimental period 2 for systolic blood pressure and experimental period 1 for diastolic blood pressure. Significant (3.6 mm Hg) and nonsignificant (1.9 mm Hg) decreases in systolic and diastolic blood pressure, respectively, were observed. The method of Hills and Armitage was used, reducing ethanol in daily alcohol consumption by 28 ml. The lowering effect of reduced alcohol consumption on blood pressure was independent of changes in salt consumption, which were estimated by 24-hour urine collection and body weight.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2006

Validity of fluorexon disodium versus sodium fluorescein for use in Goldmann tonometry.

PURPOSE: To evaluate the safety, validity, and comfort of 0.35% fluorexon disodium and 0.4% benoxinate (Flura-Safe) compared with the gold standard of 0.25% sodium fluorescein and 0.4% benoxinate for Goldmann applanation tonometry (GAT). METHODS: This was a double-masked, randomized, crossover clinical trial. Subjects received either the standard or study formulation for GAT on visit 1 and the other formulation 1 week later. At each visit, tonometer mire quality, adequacy of fluorescence, ease of intraocular pressure (IOP) measurements, the IOP value, and anesthetizing efficacy of the formulation were assessed. Subjects graded general comfort, soreness and irritation, and burning and stinging of each formulation at 1 and 5 minutes after drop instillation. RESULTS: Sixty-seven subjects completed the study. The mean IOP was 13.9 +/- 2.7 with fluorexon and 13.9 +/- 2.8 mm Hg with fluorescein OD and 14.0 +/- 2.8 with fluorexon and 13.9 +/- 2.5 mm Hg with fluorescein OS. The measurements with the 2 formulations were highly correlated for OD and OS, and the differences between the 2 measurements were not clinically significant. There was also no significant difference between the 2 drops in mire clarity, adequacy of fluorescence, or corneal anesthesia. However, fluorexon was statistically more comfortable (P = 0.039) and caused less stinging and burning (P = 0.014) at 1 minute versus the fluorescein formulation. CONCLUSION: Not only was the new fluorexon product accurate and effective in GAT, it was also statistically more comfortable and had a less stinging and burning effect at 1 minute after drop instillation than the traditional fluorescein formulation. Because fluorexon is less likely to stain soft contact lenses, this may be the dye-anesthetic formulation of choice for practices that routinely perform GAT.

Adult↗

PubMed2006

Lupin-enriched bread increases satiety and reduces energy intake acutely.

BACKGROUND: Protein and fiber may be important determinants of satiety. Lupin kernel flour is a novel food ingredient that is rich in protein and fiber. OBJECTIVE: The objective was to investigate the effects of lupin kernel flour-enriched bread (LB) on satiety and energy intake in humans. DESIGN: Two randomized controlled crossover trials were performed to compare the acute effects of LB with those of white bread (WB). In study 1, the subjects (n = 16) completed 4 treatments 1 wk apart: WB breakfast (as toast) and WB lunch (as sandwiches), WB breakfast and LB lunch, LB breakfast and WB lunch, and LB breakfast and LB lunch. Energy intake at all breakfast meals was matched (1655 kJ), and ad libitum energy intake at lunch, 3 h after breakfast, was measured. In study 2, the subjects (n = 17) completed 2 treatments 1 wk apart: WB breakfast and LB breakfast (each 1655 kJ). Blood samples were taken at baseline and at regular intervals for 3 h after breakfast. RESULTS: In study 1, the LB breakfast resulted in significantly higher self-reported satiety (P < 0.001) and lower energy intake (kJ) at lunch (-488; 95% CI: -798, -178) than did the WB breakfast. The LB lunch resulted in a significantly lower within-meal energy intake (kJ) at lunch (-1028; 95% CI: -1338, -727) than did the WB lunch. In study 2, compared with the WB breakfast, the LB breakfast significantly altered the 3-h postmeal plasma ghrelin response (P = 0.04) and resulted in significantly lower mean 3-h plasma ghrelin concentrations (P = 0.009). CONCLUSION: A novel food enriched in protein and fiber derived from lupin kernel flour significantly influences energy intake acutely.

Area Under Curve↗

PubMed2004

Lower leg growth suppression caused by inhaled glucocorticoids is not accompanied by reduced thickness of the cutis or subcutis.

BACKGROUND: Exogenous glucocorticoids suppress short-term lower leg growth in children as assessed by knemometry. The knemometric measurements, however, may be confounded by reductions in the thickness of the cutis and subcutis over the knee. AIM: To assess whether inhaled glucocorticoid-induced suppression of short-term growth is accompanied by changes in the thickness of the cutis and subcutis. METHODS: The study was a randomized, controlled, crossover trial with 1 wk treatment, run-in and washout periods. Active treatment was inhaled budesonide 200 microg twice daily. Short-term growth was assessed by knemometry, and the thickness of the cutis and subcutis over the knee, on the volar forearm and abdomen was measured by 20 MHz B-mode ultrasound. MATERIAL: Nineteen children with asthma aged 7 to 13 y. RESULTS: Lower leg growth was significantly reduced during budesonide treatment (0.27 mm/wk) compared to the treatment-free period (0.54 mm/wk) (p = 0.02, 95%: -0.50 to -0.05). Variations in the thickness of the cutis were seen during budesonide treatment (mean +/- SEM): -0.01 +/- 0.03 mm over the knee, -0.02 +/- 0.02 mm on the forearm and 0.01 +/- 0.02 mm on the abdomen. The variations in the total thickness of the cutis and subcutis were -0.05 +/- 0.12 mm, 0.06 +/- 0.12 mm and -0.06 +/- 0.10 mm during budesonide treatment. The variations in thickness of the cutis or subcutis were not statistically different during budesonide treatment and the treatment free period in any anatomical location. CONCLUSIONS: Short-term lower leg growth suppression induced by inhaled glucocorticoids is not confounded by variations in thickness of cutis or subcutis. The present observations further establishes knemometry as a reliable tool for assessment of the risk of growth suppression of inhaled glucocorticoids in children with asthma.

Abdomen↗

PubMed2000

Effect of soluble and insoluble fiber diets on serum prostate specific antigen in men.

PURPOSE: We assess whether high fiber diets influence serum prostate specific antigen (PSA) related to effects on serum sex hormone levels and fecal steroid excretion. MATERIALS AND METHODS: A randomized crossover controlled trial was performed on 14 healthy men with hyperlipidemia on 2 metabolic diets 4 months in duration with each containing foods high in soluble or insoluble fiber and approximately 25 to 30 gm. dietary fiber per 1,000 kilocalories. Serum PSA, free testosterone and estradiol, and fecal bile acid and neutral sterol excretion were evaluated. RESULTS: Mean serum PSA was lower with the soluble than the insoluble fiber diet (0.07+/-0.03 ng./ml., p = 0.035). No treatment difference was seen in free testosterone or estradiol, although the latter decreased significantly with the insoluble fiber diet (9+/-3 pmol./l., p = 0.004). After 16 weeks total fecal bile acid output was greater with the soluble (341+/-56 mg. daily) compared to the insoluble (203+/-35, p = 0.001) fiber diet but no differences were seen in fecal neutral sterol elimination. The treatment difference in fecal lithocholic acid output related to the difference in serum PSA (r = 0.57, p = 0.035). CONCLUSIONS: A small but statistically significantly lower serum PSA was seen in healthy men consuming soluble fiber, which was not related to changes in serum sex hormones but was related to the increased lithocholic acid output as a possible marker of increased fecal steroid elimination. The effect of soluble fiber on prostatic disease may warrant further investigation.

Adult↗

PubMed2004

Arabinoxylan fibre improves metabolic control in people with Type II diabetes.

OBJECTIVE: To determine whether diet supplementation with arabinoxylan-rich (AX)-fibre from wheat improves glycaemic control in Type II diabetes. DESIGN: Randomized, crossover intervention trial. SETTING: Monash Medical Centre. SUBJECTS: A total of 15 subjects with Type II diabetes. INTERVENTIONS: Over two 5-week periods, subjects supplemented their usual diet with control bread and muffins (50% whole wheat, 50% white flour) (control diet) or with AX-bread and muffins (50% whole wheat, 36% white flour, 14% AX fibre) (AX diet). Subjects completed a 7-day food diary. At 0 and 5 weeks, venous blood was collected for determination of fasting and 2 h glucose, insulin, fructosamine and blood lipids. Blood pressure, body weight and body fat were also determined. A 24 h faecal sample, from 12 subjects, was weighed and analysed for faecal polysaccharide as a marker for dietary compliance. RESULTS: Control and AX diets were similar except the AX diet supplied an additional 15.1 (12.0-18.5) (mean (95% confidence intervals)) g/day dietary fibre (P=0.000). Consumption of the AX diet increased faecal output by 61.5 (0.2-122.8) g/day (P=0.05) on a wet weight basis and significantly lowered fasting and 2 h plasma glucose, 2 h insulin and serum fructosamine (P=0.002, 0.000, 0.015, and 0.02, respectively). Blood lipids, body weight, fat mass and blood pressure remained unchanged. CONCLUSION: A supplement of 15 g/day of AX-rich fibre can significantly improve glycaemic control in people with Type II diabetes.

Blood Glucose↗

PubMed1997

Effects of exercise training and activity restriction on 6-minute walking test performance in patients with chronic heart failure.

Eighteen hospitalized patients with severe chronic heart failure (ejection fraction [mean +/- SEM] 21% +/- 1%) underwent 3 weeks of exercise training (interval bicycle ergometer and treadmill walking training exercises) and 3 weeks of activity restriction in a random-order crossover trial. Before and after exercise training and after activity restriction, a 6-minute walking test was performed to determine the maximum distance walked, hemodynamic and cardiopulmonary responses, norepinephrine levels, and ratings of leg fatigue and dyspnea while walking. A ramp test on bicycle ergometer (increments of 12.5 W/min) was performed before and after exercise training and activity restriction to determine peak oxygen uptake. After training, the maximum distance walked was increased by 65% (from 232 +/- 21 m at baseline to 382 +/- 20 m; p < 0.001), whereas after activity restriction (253 +/- 19 m) there was no significant difference compared with baseline. No significant differences in hemodynamic and cardiopulmonary parameters (with the exception of the ventilatory equivalent for carbon dioxide and perceived exertion) or norepinephrine levels were observed during walking tests. Improvement in maximum distance walked correlated significantly with training-induced increase in peak oxygen uptake measured during bicycle ergometry (r = 0.47, p < 0.05). The lower the maximum distance walked at baseline, the more pronounced the training-induced prolongation of maximum distance (r= -0.73; p < 0.001). These data support the value of exercise training in patients with severe chronic heart failure for improving maximum distance walked, as documented by the 6-minute walking test. The impairment of walking test performance during activity restriction suggests a need for long-term exercise training programs.

Activities of Daily Living↗

PubMed1986

Comparison of nicardipine and propranolol for chronic stable angina pectoris.

In a double-blind, randomized, crossover clinical trial, a new calcium antagonist, nicardipine (90 mg/day in 3 divided doses), was compared with propranolol (120 mg/day in 3 divided doses) in 25 patients with chronic stable angina. The mean weekly frequency of angina episodes decreased from 7.8 +/- 1.2 (+/- standard error of the mean) with placebo to 3.8 +/- 1.2 with nicardipine treatment and 3.5 +/- 1 with propranolol treatment (p less than 0.001). With exercise testing, 5 patients receiving nicardipine and 3 receiving propranolol had no angina or ST-segment changes. Comparing paired samples of both drugs with placebo, significant improvement occurred in exercise duration (nicardipine, 1.3 +/- 0.3 minutes, p less than 0.001; propranolol, 1.0 +/- 0.4 minutes, p less than 0.01), time to onset of angina (nicardipine, 1.5 +/- 0.4 minutes, p less than 0.001; propranolol, 1.5 +/- 0.5 minutes, p less than 0.001), maximal ST-segment changes (nicardipine, 0.7 +/- 0.1 mm, p less than 0.01; propranolol, 0.06 +/- 0.1 mm, p less than 0.01) and time to 1 mm of ST depression (nicardipine, 2.5 +/- 0.4 minutes, p less than 0.01; propranolol, 2.0 +/- 0.3 minutes, p less than 0.01). One patient receiving propranolol and 2 receiving nicardipine withdrew from the study because of transient side effects. Mild side effects occurred in 10 patients receiving propranolol and 5 receiving nicardipine. Nicardipine proved to be safe and effective for patients with chronic stable angina; it had fewer side effects than propranolol in the doses used.

Adult↗

PubMed2003

Angiotensin-converting enzyme inhibition but not angiotensin II receptor blockade regulates matrix metalloproteinase activity in patients with glomerulonephritis.

Equivalent long-term effects on the kidney are attributed to angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB). Nevertheless, it is unknown to which degree effects of these compounds on individual inflammatory mediators, including matrix metalloproteinases (MMP), are comparable. On the basis of structural and functional differences, it was hypothesized that ACEI and ARB differentially regulate MMP activity. In a randomized, prospective crossover trial, the effect of an ACEI (fosinopril; 20 mg/d) and of an ARB (irbesartan; 150 mg/d) on MMP activity was evaluated. Ten hypertensive patients with glomerulonephritis and normal or mildly reduced creatinine clearance were studied. MMP activity and tissue inhibitors of metalloproteinase (TIMP) levels were analyzed in serum and urine: without therapy, with ACEI, with ARB, and with both agents combined. Treatment periods continued for 6 wk separated by periods of 4 wk each without therapy. Untreated patients with glomerulonephritis displayed distinctively higher serum levels of MMP-2 but much lower MMP-1/-8/-9 concentrations compared with healthy control subjects. Immunohistology of MMP-2 and MMP-9 in kidney biopsy specimen was accordingly. However, these patients excreted higher amounts of MMP-2 and MMP-9 in urine than healthy control subjects, possibly reflecting ongoing glomerular inflammation. In patients with glomerulonephritis, ACEI significantly reduced overall MMP serum activity to 25%, whereas ARB did not show any effect. Activities of MMP-1/-2/-8/-9 were also significantly inhibited by fosinopril but not by irbesartan. Levels of TIMP-1/-2 remained unaffected. In conclusion, ACEI and ARB differentially regulate MMP activity, which may ultimately have consequences in certain types of MMP-dependent glomerulonephritis.

Adult↗

PubMed1992

Prevention of early-morning hyperglycemia in IDDM patients with long-acting zinc insulin.

OBJECTIVE: To evaluate whether an insulin regimen with a long-acting zinc insulin (Ultratard HM) could help control fasting hyperglycemia in insulin-dependent diabetes mellitus (IDDM) patients. RESEARCH DESIGN AND METHODS: A randomized sequential crossover trial with 6-wk treatment periods was used. Ten IDDM patients from the diabetes clinic at the Medical School who had persistent fasting hyperglycemia (greater than 10 mmol/L) were studied. Patients with nocturnal hypoglycemia were excluded. All patients completed the study. Insulin regimens consisted of three daily injections of a short-acting insulin (Actrapid HM) before meals and either a long-acting zinc insulin (Ultratard HM) or an intermediate isophane insulin (Protaphane HM) before the evening meal. Each regimen was followed for 6 wk. RESULTS: Fasting blood glucose levels (at 06:00 and 08:00) were significantly lower after the long-acting insulin regimen (6.26 +/- 0.88 vs. 10.82 +/- 4.27 mM, P less than 0.05 and 9.26 +/- 1.02 vs. 14.03 +/- 1.08 mM, P less than 0.05, respectively). Plasma-free insulin levels mirrored blood glucose concentrations because they were significantly higher at 06:00 and 08:00 after the long-acting insulin regimen (49.5 +/- 10.1 vs. 20.1 +/- 4.3 pM, P less than 0.05 and 31.6 +/- 5.0 vs. 16.5 +/- 3.4 pM, P less than 0.05, respectively). At any other time of the day, blood glucose and plasma insulin levels were not significantly different with either one of the two insulin regimens. CONCLUSIONS: A long-acting zinc human insulin injected before the evening meal can help to control persistent fasting hyperglycemia in IDDM patients.

Blood Glucose↗

PubMed2003

Diacylglycerols affect substrate oxidation and appetite in humans.

BACKGROUND: Meals rich in diacylglycerols (DGs) instead of triacylglycerols (TGs) show beneficial effects on lipid metabolism and energy balance. These effects are probably attributable to differences in DG and TG metabolism, especially postprandial fat oxidation. OBJECTIVE: We assessed the effects of partial replacement of TGs with DGs on substrate oxidation, energy expenditure (EE), relevant blood variables, and appetite. DESIGN: Twelve healthy, dietarily unrestrained women participated in a single-blind, placebo-controlled, randomized trial with crossover design. For 3 d before and throughout a 36-h stay in a respiration chamber, subjects were fed energy-maintenance amounts of a diet consisting of 55% of energy from carbohydrate, 15% from protein, and 30% from fat. In the respiration chamber, 40% of the fat was consumed as DG-rich (80% DGs) oil or as TG-based control oil with a similar fatty acid profile. RESULTS: Fat oxidation was significantly higher with DG treatment than with TG treatment. Appetite profiles during day 1 (24 h) did not differ significantly between the DG and TG treatments; however, feelings of hunger, appetite, estimated prospective food intake, and desire to eat were all significantly lower on day 2 (12 h) with DG treatment. Mean plasma beta-hydroxybutyrate tended to be higher with DG treatment, and the difference between the 2 treatments was significant at 1130 on day 2. Plasma lipid concentrations and resting and 24-h EE did not differ significantly between the 2 treatments. CONCLUSION: Consumption of DGs in place of TGs does not alter EE but produces metabolic effects, particularly increases in fat oxidation, which may be associated with improved appetite control and energy balance.

3-Hydroxybutyric Acid↗

PubMed2003

Medium- versus long-chain triglycerides for 27 days increases fat oxidation and energy expenditure without resulting in changes in body composition in overweight women.

OBJECTIVE: To determine the effects of long-term consumption of medium chain (MCT) versus long chain triglycerides (LCT) on energy expenditure (EE), substrate oxidation and body composition. HYPOTHESIS: MCT consumption will not result in greater EE, substrate oxidation, and body weight loss compared with LCT consumption. RESEARCH METHODS AND PROCEDURES: Seventeen healthy obese women participated in this randomized, crossover inpatient trial. Meals were prepared and consumed on site for two periods of 27 days. Diets containing 40% of energy as fat, with treatment fat comprising 75% of the total fat, were designed to supply each subject with their individual weight-maintaining energy needs. The MCT diet contained 67% of treatment fat as MCT oil (49% octanoate, 50% decanoate) whereas the LCT diet contained exclusively beef tallow as treatment fat. Body composition was assessed by magnetic resonance imaging (MRI) on day 1 and 28 of each phase while energy expenditure was measured on day 2 and 27. RESULTS: Changes in total and subcutaneous adipose tissue volumes following consumption of MCT and LCT were not different (-0.61+/-0.38 l vs -0.54+/-0.48 l and -0.58+/-0.35 l vs -0.48+/-0.40 l, respectively). Average EE and fat oxidation were greater (P<0.05) during MCT than LCT consumption (0.95+/-0.019 vs 0.90+/-0.024 kcal/min, respectively, for EE and 0.080+/-0.0026 vs 0.075+/-0.0022 g/min, respectively for fat oxidation). DISCUSSION: These results show that long-term consumption of MCT enhances EE and fat oxidation in obese women, when compared to LCT consumption. The difference in body composition change between MCT and LCT consumption, although not statistically different, was consistent with differences predicted by the shifts in EE. It can be concluded that substitution of MCT for LCT in a targeted energy balance diet may prevent long-term weight gain via increased EE.

Adipose Tissue↗

PubMed2000

Effect of dietary insoluble fiber on control of glycemia in cats with naturally acquired diabetes mellitus.

OBJECTIVE: To evaluate effects of dietary insoluble fiber on control of glycemia in cats with naturally acquired diabetes mellitus. DESIGN: Randomized controlled crossover trial. ANIMALS: 16 cats with naturally acquired diabetes mellitus. PROCEDURE: Cats were fed a diet high in insoluble fiber (HF) containing 12% cellulose (dry-matter basis) or a diet low in insoluble fiber (LF) for 24 weeks; they were fed the other diet for the subsequent 24 weeks. Caloric intake and insulin treatment were adjusted to maintain stable body weight and control of glycemia, respectively. Cats were allowed an adaptation period of 6 weeks after initiation of a diet, after which control of glycemia was evaluated at 6-week intervals for 18 weeks. Variables assessed included serum glucose concentration measured during the preprandial state, blood glycated hemoglobin concentration, serum glucose concentration measured at 2-hour intervals for 12 hours beginning at the time of the morning insulin injection, 12-hour mean serum glucose concentration, and mean fluctuation in serum glucose concentration from the 12-hour mean serum glucose concentration. RESULTS: Mean daily caloric intake, body weight, or daily insulin dosage did not differ significantly between cats when fed HF and LF diets. Mean preprandial serum glucose concentration, most post-prandial serum glucose concentrations, and the 12-hour mean serum glucose concentration were significantly lower when cats consumed the HF diet, compared with values when cats consumed the LF diet. CONCLUSIONS AND CLINICAL RELEVANCE: These results support feeding a commercially available diet containing approximately 12% insoluble fiber (dry-matter basis) to cats with naturally acquired diabetes mellitus.

Animals↗

PubMed1996

A pharmacokinetic comparison of acetaminophen products (Tylenol Extended Relief vs regular Tylenol)

OBJECTIVE: To compare the pharmacokinetics of Tylenol Extended Relief (ER APAP) with those of immediate-release acetaminophen (IR APAP) at supratherapeutic doses. METHODS: A prospective, double-blind, randomized, crossover comparison trial involving 14 adult volunteers. Each subject ingested 75 mg/kg of either ER APAP or IR APAP and 1 week later received the other APAP preparation. On both occasions plasma APAP concentration ([APAP]) was determined 0.5, 1, 2, 3, 4, 6, 8, 12, and 16 hours after ingestion. The times to maximum [APAP] (Tmax); the maximum [APAP] values (Cmax); the elimination half-lives 4-16 hours postingestion (t1/2), and the areas under the [APAP] vs time curve (AUC) for ER APAP and IR APAP were compared using the paired t-test. RESULTS: All the subjects completed both study phases. The mean APAP dose ingested was 5.6 g (range 4.2-7.8 g). Both the AUC and the Cmax were less after ER APAP than after IR APAP; otherwise, there was no evident difference in any measure. Graphically, ER APAP yielded a flatter, plateau-shaped curve initially, but after 4 hours the curve was nearly identical to that for IR APAP. Results are summarized in the table: [table: see text] CONCLUSION: In this model involving a single supratherapeutic dose, ER APAP evidenced no pharmacokinetic features that would suggest the need for an alternate poisoning screening strategy. When compared with IR APAP, ER APAP had a lower AUC, all peak [APAP] occurred in < 4 hours, and terminal eliminations were identical. The data suggest that, in most cases, the diagnostic approach to an overdose of ER APAP need not deviate from that used for an IR APAP overdose.

Acetaminophen↗

PubMed1993

The effect of an ibuprofen-codeine combination for the treatment of patients with pain after removal of lower third molars.

A double-blind randomized crossover analgesic trial was carried out on 70 patients undergoing surgical removal of one lower third molar at each visit. The analgesic efficacy of a two-dose regimen of the combination ibuprofen-codeine, 400 to 60 mg, was compared with ibuprofen, 400 mg. Each of the two doses was taken when the patient needed pain relief and the pain intensity was measured on a visual analog scale during the 10-hour period after the first medication. Because of carryover effects between periods 1 and 2, the analysis was carried out only for period 1 according to a parallel group design. Of the 60 patients who were evaluated for analgesic effect, the mean pain reduction of dose 1 was 63% for the 29 patients given ibuprofen-codeine and 50% for the 31 patients given ibuprofen; the mean duration of effect was 7.5 and 6.3 hours, respectively. The difference in pain reduction index (pain reduction X duration of effect) between the two treatments was significant in favor of the combination, whereas the separate variables of pain reduction and duration of effect were not significantly different. The mean pain reduction was 67% after doses 1 and 2 for patients on ibuprofen-codeine and 52% for those on ibuprofen; the mean duration of effect was 9.4 and 9.2 hours, respectively. For doses 1 and 2, the difference in pain reduction index per dose between the two treatments was significant but not the difference for the separate variables, pain reduction, and duration of effect.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗