Fracture Prevention with Zoledronate in Older Women with Osteopenia.

BACKGROUND: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with osteopenia is unknown. Most fractures in postmenopausal women occur in those with osteopenia, so therapies that are effective in women with osteopenia are needed. METHODS: We conducted a 6-year, double-blind trial involving 2000 women with osteopenia (defined by a T score of -1.0 to -2.5 at either the total hip or the femoral neck on either side) who were 65 years of age or older. Participants were randomly assigned to receive four infusions of either zoledronate at a dose of 5 mg (zoledronate group) or normal saline (placebo group) at 18-month intervals. A dietary calcium intake of 1 g per day was advised, but calcium supplements were not provided. Participants who were not already taking vitamin D supplements received cholecalciferol before the trial began (a single dose of 2.5 mg) and during the trial (1.25 mg per month). The primary end point was the time to first occurrence of a nonvertebral or vertebral fragility fracture. RESULTS: At baseline, the mean (±SD) age was 71±5 years, the T score at the femoral neck was -1.6±0.5, and the median 10-year risk of hip fracture was 2.3%. A fragility fracture occurred in 190 women in the placebo group and in 122 women in the zoledronate group (hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79; P<0.001). The number of women that would need to be treated to prevent the occurrence of a fracture in 1 woman was 15. As compared with the placebo group, women who received zoledronate had a lower risk of nonvertebral fragility fractures (hazard ratio, 0.66; P=0.001), symptomatic fractures (hazard ratio, 0.73; P=0.003), vertebral fractures (odds ratio, 0.45; P=0.002), and height loss (P<0.001). CONCLUSIONS: The risk of nonvertebral or vertebral fragility fractures was significantly lower in women with osteopenia who received zoledronate than in women who received placebo. (Funded by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12609000593235 .).

Bovine complex milk lipid containing gangliosides for prevention of rotavirus infection and diarrhoea in northern Indian infants.

Rotavirus (RV) is a leading cause of morbidity and mortality in children younger than 5 years of age, presenting commonly with diarrhoeal symptoms. In a prospective 12-week double-blind randomised controlled trial we assessed acceptability and efficacy of a high-ganglioside complex milk lipid (CML) for prevention of RV infection in 450 infants, ages 8 to 24 months, at 3 sites in northern India. Prevalence of diarrhoea and RV was unseasonably low at baseline (all-cause diarrhoea [ACD], n = 16; RV diarrhoea [RVD], n = 2; RV infection, RV positive [RV+], n = 20) and throughout the trial, with only 110 total episodes of ACD for 12 weeks (CML, n = 62; control, n = 48) of which 10 were RVD (CML, n = 4; control, n = 6). Mean duration that RVD persisted was lower in the CML group (2.3 ±â€Š0.5 days) than that in the control group (3.8 ±â€Š1.3 days, P = 0.03), but only 3 of 450 end of trial stool samples were identified as RV+ (<1%; CML, n = 2; control, n = 1). This hampered the assessment of efficacy of CML, despite the large a priori determined sample size. During the trial similar numbers of infants reported adverse events (AEs: CML 41%, control 46%), with the majority of events classified as mild and not related to the intervention. In conclusion, further clinical trials against a higher background of seasonal prevalence are necessary to assess efficacy of this nutritional intervention to prevent RVD. More important, however, high-ganglioside CML was acceptable for long-term consumption in infants ages 8 to 24 months.

Using a smaller dining plate does not suppress food intake from a buffet lunch meal in overweight, unrestrained women.

The aim of the study was to determine whether plate size affects ad libitum energy intake (EI) at a buffet-style lunch in overweight, yet unrestrained women. Twenty overweight/obese (BMI=25-40 kg/m(2)) women attended two study visits, and were randomly assigned to small (19.5 cm) or large (26.5 cm) diameter plate size at a free choice lunch meal. At 9 am participants were given a small (0.5 MJ) breakfast, followed at 12 noon by the lunch meal from which they ate ad lib until comfortably full. Mean (SEM) EI at lunch was 3975 (239)kJ and 3901 (249) kJ respectively for small and large plate size. There was no detectable difference in EI between the two plate sizes (P>0.05). When in a raised state of hunger and offered a palatable buffet meal, altering the diameter of the dining plate onto which food was self-served did not significantly alter ad lib EI. We conclude there was no evidence that a smaller plate suppressed EI in a group of unrestrained, overweight women encouraged to eat to appetite from a wide choice of items. Whether plate size is a useful cue for portion size, and hence control of EI, in individuals actively restricting intake however remains possible, and requires investigation.

Sensitivity of ad libitum meals to detect changes in hunger. Restricted-item or multi-item testmeals in the design of preload appetite studies.

The aims of the study were to determine whether restricted single-item or multi-item testmeals are better able to detect prior changes in hunger and fullness when assessing ad libitum eating behaviour. Thirty male participants were given a low- (L(E), 0.5 MJ) or high-energy (H(E), 4.0 MJ) breakfast preload designed to induce or suppress hunger, followed 3h later by a restricted-item (R(I)) or multi-item (M(I)) testmeal. The R(I) testmeal comprised pasta+meat sauce, whilst the M(I) testmeal comprised pasta+meat sauce plus bread, chicken, ham, cheese, salad, cake and fruit. The four conditions were (i) L(E)/R(I); (ii) L(E)/M(I); (iii) H(E)/R(I); (iv) H(E)/M(I). Visual analogue scales (VAS) were used to rate appetite sensations and EI was measured at the lunch testmeal. As expected, increasing the energy content of the preload significantly altered VAS ratings and decreased EI at the testmeal. Following both L(E) and H(E) breakfasts, EI was lower at the R(I) (L(E)=4566 kJ, H(E)=3583 kJ) compared with the M(I) (L(E)=6142 kJ, H(E)=5149 kJ) testmeal. However, the compensatory decrease in EI in response to the H(E) breakfast was not significantly greater at the R(I) testmeal (R(I): -983 kJ, 28.1% compensation; M(I): -993 kJ, 28.4% compensation). In preload studies measuring EI, increasing the variety of an ad lib testmeal may not decrease the sensitivity to detect changes in hunger and fullness.

Low-dose whey protein-enriched water beverages alter satiety in a study of overweight women.

AIM: To determine the effect of low-dose whey protein-enriched water beverages on postprandial satiety and energy intake (EI). METHODS: Fifty overweight and mildly obese women were given 500 mL water-based beverages on 4 different occasions in a double blind, cross-over study. The beverages were reasonably matched for colour, flavour, sweetness and contained 0% (water control, 0 g, 8 kJ), 1% (5 g, 93 kJ), 2% (10 g, 178 kJ) and 4% (20 g, 348 kJ) whey protein by weight (ClearProtein8855™). Following a standard evening meal and breakfast, beverages were consumed 120 min before an ad libitum lunch at which EI was measured. Feelings associated with hunger and fullness were also measured using visual analogue scales (VAS). RESULTS: 46 participants completed all 4 beverage conditions. There was a significant effect of beverage preload on hunger (beverage×time; P=0.0074), where each of the 1%, 2% and 4% w/w protein beverages decreased hunger compared to the water control (P<0.05). Suppression of hunger was also maintained for longer following the protein beverages (Friedman test, P=0.013). Fullness (beverage×time; P=0.0020) and satisfaction (beverage×time; P=0.0356) were both increased by the 1% and 4% protein beverages (P<0.05). EI at lunch decreased by up to 8 percent (control vs 4% protein, delta=-247 kJ, Tukey's post hoc, P>0.05) when escalating protein doses were added to the water preload (water control, 3028 kJ; 1%, 3080 kJ; 2%, 2924 kJ; 4%, 2781 kJ), only partial compensation for the added energy. CONCLUSIONS: These low-dose, whey protein-enriched water beverages significantly altered short term postprandial satiety, however the effect was not sufficient to impact on food intake when assessed 2 h after consumption.

Effects of lipid emulsion particle size on satiety and energy intake: a randomised cross-over trial.

BACKGROUND/OBJECTIVES: Emulsified lipids, with central lipid core surrounded by polar lipid 'protective coat', have been proposed to stimulate the ileal brake, alter appetite, food intake and aid weight control. In addition to lipid composition, emulsion particle size may contribute to efficacy with small droplets providing a larger surface area for gastrointestinal (GI) lipase action and larger droplets prolonging and delaying digestion in the GI tract. Tube feeding studies delivering emulsions directly into the small intestine show clear effects of smaller particle size on appetite and food intake, but evidence from oral feeding studies is sparse. The objective of this study was to determine the effects of lipid emulsion particle size on appetite response and food intake. SUBJECTS/METHODS: In a three-arm randomised cross-over, high-phospholipid (PL) dairy lipid emulsions or matched control were consumed at breakfast within a yoghurt smoothie: (i) large-particle size emulsion, LPE (diameter 0.759 µm, 10 g lipid emulsion, 190 g yoghurt), (ii) small-particle size emulsion, SPE (diameter 0.290 µm, 10 g lipid emulsion, 190 g yoghurt), (iii) control non-emulsion, NE (10 g non-emulsion lipid, 190 g yoghurt). Twenty male participants completed the study, where postprandial appetite response was rated using visual analogue scales (VAS) and ad libitum energy intake at a lunch meal measured 3 h later. RESULTS: There was a trend for LPE to suppress hunger (P = 0.08) and enhance fullness (P = 0.24) relative to both SPE and NE but not statistically significant, and no significant effect of either emulsion on food intake at the lunch meal (P > 0.05). CONCLUSIONS: Altering particle size of a high-PL emulsion did not enhance satiety or alter eating behaviour in a group of lean men.