Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability.

BACKGROUND: Phosphate binders are required to control serum phosphorus in dialysis patients. A phosphate binder combining calcium and magnesium offers an interesting therapeutic option. METHODS: This controlled randomized, investigator-masked, multicentre trial investigated the effect of calcium acetate/magnesium carbonate (CaMg) on serum phosphorus levels compared with sevelamer hydrochloride (HCl). The study aim was to show non-inferiority of CaMg in lowering serum phosphorus levels into Kidney Disease Outcome Quality Initiative (K/DOQI) target level range after 24 weeks. Three hundred and twenty-six patients from five European countries were included. After a phosphate binder washout period, 255 patients were randomized in a 1:1 fashion. Two hundred and four patients completed the study per protocol (CaMg, N = 105; dropouts N = 18; sevelamer-HCl, N = 99; dropouts N = 34). Patient baseline characteristics were similar in both groups. RESULTS: Serum phosphorus levels had decreased significantly with both drugs at week 25, and the study hypothesis of CaMg not being inferior to sevelamer-HCl was confirmed. The area under the curve for serum phosphorus (P = 0.0042) and the number of visits above K/DOQI (≤1.78 mmol/L, P = 0.0198) and Kidney disease: Improving global outcomes (KDIGO) targets (≤1.45 mmol/L, P = 0.0067) were significantly lower with CaMg. Ionized serum calcium did not differ between groups; total serum calcium increased in the CaMg group (treatment difference 0.0477 mmol/L; P = 0.0032) but was not associated with a higher risk of hypercalcaemia. An asymptomatic increase in serum magnesium occurred in CaMg-treated patients (treatment difference 0.2597 mmol/L, P < 0.0001). There was no difference in the number of patients with adverse events. CONCLUSION: CaMg was non-inferior to the comparator at controlling serum phosphorus levels at Week 25. There was no change in ionized calcium; there was minimal increase in total serum calcium and a small increase in serum magnesium. It had a good tolerability profile and thus may represent an effective treatment of hyperphosphataemia.

Effects of a low-glycemic load vs low-fat diet in obese young adults: a randomized trial.

CONTEXT: The results of clinical trials involving diet in the treatment of obesity have been inconsistent, possibly due to inherent physiological differences among study participants. OBJECTIVE: To determine whether insulin secretion affects weight loss with 2 popular diets. DESIGN, SETTING, AND PARTICIPANTS: Randomized trial of obese young adults (aged 18-35 years; n = 73) conducted from September 2004 to December 2006 in Boston, Mass, and consisting of a 6-month intensive intervention period and a 12-month follow-up period. Serum insulin concentration at 30 minutes after a 75-g dose of oral glucose was determined at baseline as a measure of insulin secretion. Outcomes were assessed at 6, 12, and 18 months. Missing data were imputed conservatively. INTERVENTIONS: A low-glycemic load (40% carbohydrate and 35% fat) vs low-fat (55% carbohydrate and 20% fat) diet. MAIN OUTCOME MEASURES: Body weight, body fat percentage determined by dual-energy x-ray absorptiometry, and cardiovascular disease risk factors. RESULTS: Change in body weight and body fat percentage did not differ between the diet groups overall. However, insulin concentration at 30 minutes after a dose of oral glucose was an effect modifier (group x time x insulin concentration at 30 minutes: P = .02 for body weight and P = .01 for body fat percentage). For those with insulin concentration at 30 minutes above the median (57.5 microIU/mL; n = 28), the low-glycemic load diet produced a greater decrease in weight (-5.8 vs -1.2 kg; P = .004) and body fat percentage (-2.6% vs -0.9%; P = .03) than the low-fat diet at 18 months. There were no significant differences in these end points between diet groups for those with insulin concentration at 30 minutes below the median level (n = 28). Insulin concentration at 30 minutes after a dose of oral glucose was not a significant effect modifier for cardiovascular disease risk factors. In the full cohort, plasma high-density lipoprotein cholesterol and triglyceride concentrations improved more on the low-glycemic load diet, whereas low-density lipoprotein cholesterol concentration improved more on the low-fat diet. CONCLUSIONS: Variability in dietary weight loss trials may be partially attributable to differences in hormonal response. Reducing glycemic load may be especially important to achieve weight loss among individuals with high insulin secretion. Regardless of insulin secretion, a low-glycemic load diet has beneficial effects on high-density lipoprotein cholesterol and triglyceride concentrations but not on low-density lipoprotein cholesterol concentration. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00130299.

Effects of an ad libitum low-glycemic load diet on cardiovascular disease risk factors in obese young adults.

BACKGROUND: The optimal nutritional approach for the prevention of cardiovascular disease among obese persons remains a topic of intense controversy. Available approaches range from conventional low-fat to very-low-carbohydrate diets. OBJECTIVE: The aim of this pilot study was to evaluate the efficacy of an ad libitum low-glycemic load diet, without strict limitation on carbohydrate intake, as an alternative to a conventional low-fat diet. DESIGN: A randomized controlled trial compared 2 dietary treatments in obese young adults (n = 23) over 12 mo. The experimental treatment emphasized ad libitum consumption of low-glycemic-index foods, with 45-50% of energy from carbohydrates and 30-35% from fat. The conventional treatment was restricted in energy (250-500 kcal/d deficit) and fat (<30% of energy), with 55-60% of energy from carbohydrate. We compared changes in study outcomes by repeated-measures analysis of log-transformed data and expressed the results as mean percentage change. RESULTS: Body weight decreased significantly over a 6-mo intensive intervention in both the experimental and conventional diet groups (-8.4% and -7.8%, respectively) and remained below baseline at 12 mo (-7.8% and -6.1%, respectively). The experimental diet group showed a significantly greater mean decline in plasma triacylglycerols than did the conventional diet group (-37.2% and -19.1%, respectively; P = 0.005). Mean plasminogen activator inhibitor 1 concentrations decreased (-39.0%) in the experimental diet group but increased (33.1%) in the conventional diet group (P = 0.004). Changes in cholesterol concentrations, blood pressure, and insulin sensitivity did not differ significantly between the groups. CONCLUSION: An ad libitum low-glycemic load diet may be more efficacious than a conventional, energy-restricted, low-fat diet in reducing cardiovascular disease risk.

A reduced-glycemic load diet in the treatment of adolescent obesity.

BACKGROUND: The incidence of type 2 diabetes increases markedly for obese children after puberty. However, the effect of dietary composition on body weight and diabetes risk factors has not been studied in adolescents. OBJECTIVE: To compare the effects of an ad libitum, reduced-glycemic load (GL) diet with those of an energy-restricted, reduced-fat diet in obese adolescents. DESIGN: Randomized control trial consisting of a 6-month intervention and a 6-month follow-up. MAIN OUTCOME MEASURES: Body composition (body mass index [BMI; calculated as weight in kilograms divided by the square of height in meters] and fat mass) and insulin resistance (homeostasis model assessment) were measured at 0, 6, and 12 months. Seven-day food diaries were used as a process measure. SUBJECTS: Sixteen obese adolescents aged 13 to 21 years. Intervention Experimental (reduced-GL) treatment emphasized selection of foods characterized by a low to moderate glycemic index, with 45% to 50% of energy from carbohydrates and 30% to 35% from fat. In contrast, conventional (reduced-fat) treatment emphasized selection of low-fat products, with 55% to 60% of energy from carbohydrates and 25% to 30% from fat. RESULTS: Fourteen subjects completed the study (7 per group). The GL decreased significantly in the experimental group, and dietary fat decreased significantly in the conventional group (P<.05 for both). At 12 months, mean +/- SEM BMI (-1.3 +/- 0.7 vs 0.7 +/- 0.5; P =.02) and fat mass (-3.0 +/- 1.6 vs 1.8 +/- 1.0 kg; P =.01) had decreased more in the experimental compared with the conventional group, differences that were materially unchanged in an intention-to-treat model (n = 16) (BMI, P =.02; fat mass, P =.01). Insulin resistance as measured by means of homeostasis model assessment increased less in the experimental group during the intervention period (-0.4 +/- 0.9 vs 2.6 +/- 1.2; P =.02). In post hoc analyses, GL was a significant predictor of treatment response among both groups (R2 = 0.51; P =.006), whereas dietary fat was not (R2 = 0.14; P =.22). CONCLUSIONS: An ad libitum reduced-GL diet appears to be a promising alternative to a conventional diet in obese adolescents. Large-scale randomized controlled trials are needed to further evaluate the effectiveness of reduced-GL and -glycemic index diets in the treatment of obesity and prevention of type 2 diabetes.

Effects of a low-glycemic load diet in overweight and obese pregnant women: a pilot randomized controlled trial.

BACKGROUND: The optimal diet for pregnancy that is complicated by excessive weight is unknown. OBJECTIVE: We aimed to examine the effects of a low-glycemic load (low-GL) diet in overweight and obese pregnant women. DESIGN: We randomly assigned 46 overweight or obese pregnant women to receive a low-GL or a low-fat diet. Participants received carbohydrate-rich foods, fats, and snack foods through home delivery or study visits. The primary outcome was birth weight z score. Other endpoints included infant anthropometric measurements, gestational duration, maternal weight gain, and maternal metabolic parameters. RESULTS: There were no significant differences in birth weight z score or other measures of infant adiposity between groups. However, in the low-GL compared with the low-fat group, gestational duration was longer (mean ± SD: 39.3 ± 1.1 compared with 37.9 ± 3.1 wk; P = 0.05) and fewer deliveries occurred at ≤ 38.0 wk (13% compared with 48%, P = 0.02; with exclusion of planned cesarean deliveries: 5% compared with 53%; P = 0.002). Adjusted head circumference was greater in the low-GL group (35.0 ± 0.8 compared with 34.2 ± 1.3 cm, P = 0.01). Women in the low-GL group had smaller increases in triglycerides [median (interquartile range): 49 (19, 70) compared with 93 (34, 129) mg/dL; P = 0.03] and total cholesterol [13 (0, 36) compared with 33 (22, 56) mg/dL, P = 0.04] and a greater decrease in C-reactive protein [-2.5 (-5.5, -0.7) compared with -0.4 (-1.4, 1.5) mg/dL, P = 0.007]. CONCLUSIONS: A low-GL diet resulted in longer pregnancy duration, greater infant head circumference, and improved maternal cardiovascular risk factors. Large-scale studies are warranted to evaluate whether dietary intervention during pregnancy aimed at lowering GL may be useful in the prevention of prematurity and other adverse maternal and infant outcomes. This trial is registered at clinicaltrials.gov as NCT00364403.

Altering portion sizes and eating rate to attenuate gorging during a fast food meal: effects on energy intake.

OBJECTIVE: Eating large amounts of food at a rapid rate, defined as gorging, may contribute to excess energy intake. We aimed to evaluate whether altering portion sizes and eating rate could decrease energy intake during an extra-large fast food meal. METHODS: Subjects were adolescents (n = 18), 13 to 17 years of age, who reported eating fast food > or =1 time per week. BMI exceeded the 80th percentile for all subjects. Three feeding conditions were evaluated with a crossover design. Total amounts and types of foods and beverage served during the meal were held constant across conditions, equaling approximately 125% of that consumed during a baseline assessment visit when subjects were offered unlimited amounts. The meal (chicken nuggets, French fries, and cola) was presented as 1 large serving at a single time point (condition A, standard), portioned into 4 smaller servings presented at a single time point (condition B, effects of portioning), or portioned into 4 smaller servings presented at 15-minute intervals (condition C, effects of portioning and eating rate). Energy intake across conditions was compared by using analysis of variance. RESULTS: Energy intake was not significantly different, whether expressed in kilojoules (mean +/- SEM: condition A, 5552 +/- 357 kJ; condition B, 5321 +/- 433 kJ; condition C, 5762 +/- 500 kJ) or relative to total daily energy expenditure (mean +/- SEM: condition A, 51.9 +/- 3.5%; condition B, 48.2 +/- 4.0%; condition C, 53.0 +/- 4.3%). CONCLUSIONS: Adolescents consumed approximately 50% of energy needs regardless of manipulations in portion sizes and eating rate to attenuate gorging. This finding suggests that nutritional factors inherent to fast food, such as low levels of dietary fiber, high palatability, high energy density, high fat content, high glycemic load, and high content of sugar in liquid form promote excess energy intake.