A Vitamin D, Calcium and Leucine-Enriched Whey Protein Nutritional Supplement Improves Measures of Bone Health in Sarcopenic Non-Malnourished Older Adults: The PROVIDE Study.

Alterations in musculoskeletal health with advanced age contribute to sarcopenia and decline in bone mineral density (BMD) and bone strength. This decline may be modifiable via dietary supplementation. To test the hypothesis that a specific oral nutritional supplement can result in improvements in measures of bone health. Participants (n 380) were participants of the PROVIDE study, a 13-week, multicenter, randomized, controlled, double-blind, 2 parallel-group study among non-malnourished older participants (≥ 65 years) with sarcopenia [determined by Short Physical Performance Battery (SPPB; 0-12) scores between 4 and 9, and a low skeletal muscle mass index (SMI; skeletal muscle mass/BW × 100) ≤ 37% in men and ≤ 28% in women using bioelectric impedance analysis] Supplementation of a vitamin D, calcium and leucine-enriched whey protein drink that comprises a full range of micronutrients (active; 2/day) was compared with an iso-caloric control. Serum 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), biochemical markers of bone formation (osteocalcin; OC, procollagen type 1 amino-terminal propeptide; P1NP) and resorption (carboxy-terminal collagen crosslinks; CTX), insulin like growth factor 1 (IGF-1) and total-body BMD were analysed pre- and post-intervention. Serum 25(OH)D concentrations increased from 51.1 ± 22.9 nmol/L (mean ± SD) to 78.9 ± 21.1 nmol/L in the active group (p < 0.001 vs. control). Serum PTH showed a significant treatment difference (p < 0.001) with a decline in the active group, and increase in the control group. Serum IGF-1 increased in the active group (p < 0.001 vs. control). Serum CTX showed a greater decline in the active group (p = 0.001 vs. control). There were no significant differences in serum OC or P1NP between groups during the intervention. Total body BMD showed a small (0.02 g/cm2; ~ 2%) but significant increase in the active group after supplementation (p = 0.033 vs. control). Consuming a vitamin D, calcium and leucine-enriched whey protein supplement for 13 weeks improved 25(OH)D, suppressed PTH and had small but positive effects on BMD, indicative of improved bone health, in sarcopenic non-malnourished older adults.

Programming implantable cardioverter-defibrillators in patients with primary prevention indication to prolong time to first shock: results from the PROVIDE study.

BACKGROUND: Shock therapy delivery by implantable cardioverter-defibrillators (ICD) can be painful and may have adverse consequences. Reducing shock burden for patients with ICDs would be beneficial. METHODS: PROVIDE was a prospective, randomized study of primary prevention ICD patients. Patients in the experimental group received a combination of programmed parameters with higher detection rates, longer detection intervals, empiric antitachycardia pacing (ATP), and optimized supraventricular tachycardia (SVT) discriminators, while those in the control group were programmed with conventional parameters. Shock therapy and arrhythmic syncope were compared. RESULTS: Of 1,670 patients enrolled (846 in the experimental group, 824 in the control group) and monitored over a follow-up of 530 ± 241 days, 202 patients received shock therapy for any cause (82 in the experimental group and 120 in the control group). The median time to first shock was significantly prolonged (13.1 vs 7.8 months, hazard ratio [HR]: 0.62, 95% confidence interval [CI]: 0.47 to 0.82, P = 0.0005) and the 2-year shock rate significantly reduced (12.4% vs 19.4%, P < 0.001) in the experimental group compared to the control group. There was no increase in arrhythmic syncope (HR: 1.64, 95% CI: 0.69 to 3.90, P = 0.26), while the overall mortality was reduced (HR: 0.7, 95% CI: 0.50 to 0.98, P = 0.036) in the experimental group compared to the control group. CONCLUSION: A combination of programmed parameters utilizing higher detection rate, longer detection intervals, empiric ATP, and optimized SVT discriminators reduced ICD therapies without increasing arrhythmic syncope and was associated with reduction in all-cause mortality among ICD patients.