Correlation Between Cardiac Index, Plasma Troponin I, Myocardial Histopathology, CPB and AoX Duration in Glutamine versus No Glutamine Administered Patients with Low Ejection Fraction Undergoing Elective On-Pump CABG Surgery: Secondary Analysis of an RCT.

Purpose: On-pump coronary artery bypass graft (CABG) causes myocardial ischemia, through the cardiopulmonary bypass (CPB) and aortic cross-clamping (AoX). Glutamine supplementation protects cardiac cells during cardiac ischemia. This study analysed the correlation between cardiac index (CI), plasma troponin I, myocardial histopathology, CPB and AoX duration in low ejection fraction patients receiving glutamine and no glutamine undergoing elective on-pump CABG. Material and Methods: This was a secondary analysis of a double-blind, randomised controlled trial of 60 patients, split into control and intervention (glutamine) groups. Glutamine was administered at a dose of 0.5 g/kg/24 hours. There were 29 patients in each respective groups after a total of two patients dropped out. Results: A negative correlation (p = 0.037) was observed between CPB duration and CI at 6 hours after CPB in the glutamine group. A positive correlation (p = 0.002) was also observed between AoX duration and plasma troponin I at 6 hours after CPB in the control group. However, no correlation was observed between myocardial histopathology and plasma troponin I level at 5 minutes after CPB. Conclusion: Significant negative correlation between CPB duration and CI at 6 hours after CPB in the glutamine group, along with significant positive correlation between AoX duration and plasma troponin I level at 6 hours after CPB in the control group demonstrated the myocardial protection qualities of intravenous glutamine administration in patients with low ejection fraction undergoing elective on-pump CABG surgeries.

A multicentre randomized controlled trial of food supplement intervention for wasting children in Indonesia-study protocol.

BACKGROUND: After the first six months of exclusive breastfeeding, children are introduced to liquids and semi-solid food, known as the complementary feeding phase. This phase is critical because it is often accompanied by improper feeding in children, which may lead to wasting and other nutrition problems. Fortified biscuits have been provided for wasting children as a nationwide programme. However, the ability of children to accept food supplementation remains questionable. This paper describes the protocol of a study investigating the efficacy of food supplementation (PMT biscuit) and nutrition education to improve the nutritional status of wasting children in Indonesia. METHOD: The efficacy of a government food supplementation programme will be examined using a randomized control trial design. Parents with wasting children aged 6-17 months will be recruited to participate in the study. After obtaining informed consent and pre-intervention measures, participants will be assigned into three arms of intervention with PMT biscuits and/or nutrition education only. The two primary outcomes for this study are the nutritional status of wasting children and PMT biscuit compliance. Characteristics of all subjects in each arm will be analysed and compared with each other to assess their comparability at the beginning. The data will be collected at pre-intervention, at 3 months of intervention, post-intervention, and at the 6- to 9-month follow up. DISCUSSION: This paper aims to describe the study protocol of a randomized controlled trial investigating the effects of different PMT biscuit portion and nutrition education in two arms and nutrition education only in another arm. This study is important because it will provide evidence for the Indonesian government regarding the efficacy of food supplementation and/or food-based recommendations to improve the nutritional status of wasting children aged 6-23 months in Indonesia. TRIAL REGISTRATION: The study has been registered at clinicaltrials.gov, maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), on April 26, 2018, and was last updated on April 30, 2018 (registration number: NCT03509155 ).

Effect of soy isoflavone supplementation on vascular endothelial function and oxidative stress in postmenopausal women: a community randomized controlled trial.

A 12-month randomized double blind controlled trial was conducted among 182 Indonesian postmenopausal women aged 47 to 60 years to determine the effect of 100 mg/day soy isoflavone supplementation on vascular endothelial function such as vascular cell adhesion molecule-1 (VCAM-1), nitric oxide (NO) and malondialdehyde (MDA) as oxidative stress marker. The subjects were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavones and calcium carbonate 500 mg, and to the control group receiving 500 mg calcium carbonate. The concentrations of VCAM-1, NO and MDA were measured at baseline, and postsupplementation at 6 months and 12 months. After supplementation, the MDA concentrations were significantly lower in the soy isoflavone group compared with the control group (p=0.001). The concentrations of VCAM-1 and NO were not affected (p=0.992 and p=0.759, respectively). In all group the MDA concentration increased compared with baseline concentrations but the relative change of MDA concentrations was significantly lower in the soy isoflavone group compared with the control group. This study demonstrates that supplemental intake of soy isoflavones for 6 months and 12 months had an effect on oxidative stress by decreasing MDA concentration, but did not improve vascular endothelial function.