Salivary Cortisol Levels and Clinical Signs of Stress in Premature Neonates Treated with Vimala Massage: A Randomized Controlled Trial.

Background: In neonatal intensive care units across the world, premature neonates are exposed to a very stressful environment with high levels of noise, bright lights, pain, infections, invasive procedures, and a lack of maternal contact. Stress is manifested by increased cortisol levels and clinical signs of stress. Objective: To assess the impact of Vimala massage on (1) salivary cortisol levels (primary outcome) and (2) clinical signs of stress (secondary outcomes) in premature neonates. Methods: Neonates (28-36 weeks gestational age) admitted to a nursery unit were randomized one-to-one to receive 15-20 min of Vimala massage administered by their parents twice daily and usual care, or to usual care alone. Salivary cortisol levels were measured by enzyme-linked immunosorbent assay (ELISA) on days 1 and 5. Heart rate, respiratory rate, caloric intake, weight gain, and growth were recorded daily. Groups were compared with t tests, U-tests, and repeated measures analysis of variance. Results: Seventy neonates, 35 in each group, were included. Groups were comparable at baseline. The median decrease in salivary cortisol levels was 0.12 µg/dL in the massage group and 0.07 µg/dL in the control group (p = 0.22). Over 5 days, the massage group had significant decreases in resting heart rate (p = 0.003) and respiratory rate (p = 0.028), and greater weight gains (p = 0.0002), relative to controls. Conclusions: In this randomized trial, adding Vimala massage to usual nursery care was not associated with a significant decrease in salivary cortisol levels in premature neonates, when compared with usual nursery care alone. There were improvements in clinical signs of stress.

Reduction of small dense LDL and Il-6 after intervention with Plantago psyllium in adolescents with obesity: a parallel, double blind, randomized clinical trial.

Obesity can lead children and adolescents to an increased cardiovascular disease (CVD) risk. A diet supplemented with Plantago psyllium has been shown to be effective in reducing LDL-C and IL-6 in adolescents. However, there are no studies that have explored small-dense LDL (sdLDL) or HDL subclasses. The aim of this study was to evaluate the impact of a fiber dietary intervention on LDL and HDL subclasses in adolescents with obesity. In this parallel, double blind, randomized clinical trial, the participants were assigned to Plantago psyllium or placebo (10g/day for 7 weeks). We randomized 113 participants, and evaluated and analyzed 100 adolescents (50 in each group), 15 to 19 years with a body mass index of 29-34. We measured biochemical markers LDL and HDL subclasses using the Lipoprint system (Quantimetrix) and IL-6 by ELISA. Post-treatment there was a decrease in sdLDL between the groups 2.0 (0-5.0) vs 1 (0-3.0) mg/dl (p = 0.004), IL-6 median 3.32 (1.24-5.96) vs 1.76 (0.54-3.28) pg/ml, p <0.0001. There were no differences in HDL subclasses and no adverse effects were reported in either group.Conclusions: Small dense LDL and IL-6 reduced in adolescents with obesity when consuming Plantago psyllium. This may be an early good strategy for the reduction of cardiovascular disease risk in this vulnerable population.Trial registration: ISRCTN # 14180431. Date assigned 24/08/2020 What is Known: • Supplementing the diet with Plantago psyllium lowers LDL-C levels. What is New: • First evidence that soluble fiber supplementation like Plantago psyllium decreases small dense LDL particles in association with lowered IL-6, reducing the risk of cardiovascular disease in obese adolescents.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.