Study protocol for an open labelled randomised controlled trial of perioperative oral nutrition supplement in breast and colorectal cancer patients undergoing elective surgery.

BACKGROUND: While it is well established that perioperative use of oral nutrition supplement (ONS) improves nutrition status among severely malnourished surgical cancer patients, the evidence requires further substantiation for non-severely malnourished patients with cancer. This protocol paper presents the rationale and design of a randomised controlled trial to evaluate the effectiveness of preoperative as well as an extended 90-day postoperative use of ONS on nutritional and clinical outcomes among patients undergoing elective surgery for breast and colorectal cancer. METHODS: Patients with primary breast and colorectal cancer undergoing elective surgery are recruited from two tertiary hospitals. Eligible patients are assigned into one of the three intervention arms: (i) Group SS will receive ONS in addition to their normal diet up to 14 days preoperatively and postoperatively up to discharge; (ii) Group SS-E will receive ONS in addition to their normal diet up to 14 days preoperatively, postoperatively up to discharge and for an extended 90 days after discharge; and (iii) Group DS will receive ONS in addition to their normal diet postoperatively up to discharge from the hospital. The ONS is a standard formula fortified with lactium to aid in sleep for recovery. The primary endpoints include changes in weight, body mass index (BMI), serum albumin and prealbumin levels, while secondary endpoints are body composition (muscle and fat mass), muscle strength (handgrip strength), energy and protein intake, sleep quality, haemoglobin, inflammatory markers (transferrin, high sensitivity C-reactive protein, interleukin-6), stress marker (saliva cortisol), length of hospital stay and postoperative complication rate. DISCUSSION: This trial is expected to provide evidence on whether perioperative supplementation in breast and colorectal cancer patients presenting with high BMI and not severely malnourished but undergoing the stress of surgery would be beneficial in terms of nutritional and clinical outcomes. TRIAL REGISTRATION: ClinicalTrial.gov NCT04400552. Registered on 22 May 2020, retrospectively registered.

The Family Diet Study: a cross-sectional study into the associations between diet, food habits and body weight status in Malay families.

BACKGROUND: Childhood obesity is becoming more common as Malaysia experiences rapid nutrition transition. Current evidence related to parental influences on child dietary intake and body weight status is limited. The present study aimed to report, among Malay families, the prevalence of energy mis-reporting and dietary relationships within family dyads. METHODS: The cross-sectional Family Diet Study (n = 236) was conducted at five primary schools in central of Peninsular Malaysia. Each family consisted of a Malay child, aged 8-12 years, and their main caregiver(s). Information on socio-demographics, dietary intake and anthropometry were collected. Correlations and regression analyses were used to assess dietary relationships within family dyads. RESULTS: Approximately 29.6% of the children and 75.0% parents were categorised as being overweight or obese. Intakes of nutrients and food groups were below the national recommended targets for majority of children and adults. A large proportion of energy intake mis-reporters were identified: mothers (55.5%), fathers (40.2%) and children (40.2%). Children's body mass index (BMI) was positively associated with parental BMI (fathers, r = 0.37; mothers, r = 0.34; P < 0.01). For dietary intakes, moderate-to-strong (0.35-0.72) and weak-to-moderate (0.16-0.35) correlations were found between mother-father and child-parent dyads, respectively. Multiple regression revealed that maternal percentage energy from fat (ß = 0.09, P < 0.01) explained 81% of the variation in children's fat intake. CONCLUSIONS: Clear parental dietary relationships, especially child-mother dyads, were found. Despite a significant proportion of families with members who were overweight or obese, the majority reported dietary intakes below recommended levels, distorted by energy mis-reporting. The findings of the present study can inform interventions targeting parent-child relationships to improve family dietary patterns in Malaysia.

Community-based cardiovascular Risk Factors Intervention Strategies (CORFIS) in managing hypertension: A pragmatic non-randomised controlled trial.

BACKGROUND: Hypertension is the number one cardiovascular risk factor in Malaysia. This study aimed to evaluate the effectiveness of a Community-Based Cardiovascular Risk Factors Intervention Strategies (CORFIS) in the management of hypertension in primary care. METHODS: This is a pragmatic, non-randomized controlled trial. Seventy general practitioners (GPs) were selected to provide either CORFIS (44 GPs) or conventional care (26 GPs) for 6 months. A total of 486 hypertensive patients were recruited; 309 were in the intervention and 177 in the control groups. Primary outcome was the proportion of hypertensive patients who achieved target blood pressure (BP) of <140/90mmHg (for those without diabetes mellitus) and <130/80mmHg (with diabetes mellitus). Secondary outcomes include change in the mean/median BP at 6-month as compared to baseline. RESULTS: The proportion of hypertensive patients who achieved target BP at 6-month was significantly higher in the CORFIS arm (69.6%) as compared to the control arm (57.6%), P=0.008. Amongst those who had uncontrolled BP at baseline, the proportion who achieved target BP at 6-month was also significantly higher in the CORFIS arm (56.6%) as compared to the control arm (34.1%), p<0.001. There was no difference in the patients who had already achieved BP control at baseline. There were significant reductions in SBP in the CORFIS arm (median -9.0mmHg; -60 to 50) versus control (median -2mmHg; -50 to 48), p=0.003; as well as in DBP (CORFIS arm: median -6.0mmHg; ranged from -53 to 30 versus control arm: median 0.0mmHg; ranged from -42 to 30), p<0.001. CONCLUSIONS: Patients who received CORFIS care demonstrated significant improvements in achieving target BP.

Hesperidin inhibits ovariectomized-induced osteopenia and shows differential effects on bone mass and strength in young and adult intact rats.

The main aim of this study was to investigate the bone-sparing effect of hesperidin, one of the main flavonoid present in oranges, in two age groups of ovariectomized female rats, compared with their intact controls. Young (3 mo) and adult (6 mo) female Wistar rats were sham operated (SH) or ovariectomized (OVX) and then pair-fed for 90 days a casein-based diet supplemented or not with 0.5% hesperidin (Hp; n = 10/group). In older rats, Hp intake led to a partial inhibition of OVX-induced bone loss, whereas a complete inhibition was obtained in younger animals. At both ages, while plasma osteocalcin concentrations were unchanged, urinary excretion of deoxypyridinoline was reduced by Hp intake, suggesting that Hp was able to slow down bone resorption. Unexpectedly, in intact young rats, Hp consumption resulted in a significant increase in bone mineral density (BMD). Indeed, 6-mo-old HpSH rats had a similar BMD to 9-mo-old nontreated SH adult rats, suggesting an accelerated bone mass gain in the young rats. In contrast, in intact adult rats, Hp did not further increase BMD but did improve their bone strength. The results of this study show a protective effect of Hp on bone loss in OVX rats of both ages without uterine stimulation and accompanied by a lipid-lowering effect. The unexpected and intriguing findings obtained in intact rats showing improved BMD in young rats and improved femoral load in adult rats merit further investigation. The bone and lipid benefits of hesperidin make it an attractive dietary agent for the management of the health of postmenopausal women.

A follow-up study on the effects of a milk supplement on bone mineral density of postmenopausal Chinese women in Malaysia.

BACKGROUND: A previous study on a randomized controlled trial in 173 postmenopausal Chinese women in Kuala Lumpur showed that milk supplementation was effective to reduce bone loss at the total body, lumbar spine, femoral neck and total hip compared to the control group on a usual diet (Chee et al. 2003). OBJECTIVE: The objective was to determine whether the results were sustained after the conclusion of the study. DESIGN: A follow-up study, 18 months after a randomized controlled trial of milk supplementation was concluded. A total of 139 participants were followed up 21 months after the study ended. Bone mineral density (BMD) was measured at the total body, lumbar spine, femoral neck and total hip by dual energy X-ray absorptiometry, and anthropometric measurements as well as changes in dietary habits were measured. RESULTS: At the follow-up, the milk supplement group did not show significant bone loss from baseline at most sites (mean differences +/- SE) (total body 0.42 +/- 0.25%, femoral neck 0.44 +/- 0.58%, total hip -0.06 +/- 0.46%), unlike the control group (total body -1.07 +/- 0.28% p < 0.005, femoral neck -1.49 +/- 0.56% p < 0.05, total hip -0.89 +/- 0.57% p < 0.05). However, both the milk and control groups showed bone loss from baseline at the lumbar spine (milk -2.01%, control -3.29%, p superior 0.05). The calcium intake of the milk group remained significantly higher than the control group (milk 710 mg/day, control 466 mg/day, p < 0.005) despite discontinuation of the milk supplement. CONCLUSIONS: The results showed that some of the beneficial effects of a milk supplement were still evident at follow-up and it was possible to motivate subjects to adopt a positive change in dietary calcium intake after intervention.

Vitamin D status among postmenopausal Malaysian women.

Serum levels of 25-hydroxyvitamin D (25 (OH) D) were determined in 276 (103 Malays and 173 Chinese) postmenopausal women, aged 50 to 65 years. The level of 25 (OH) D was significantly lower in the postmenopausal Malay women (44.4 +/-10.6 nmol/L) compared to the Chinese women (68.8 +/- 15.7 nmol/L) (P<0.05). There were 27% Malay women with serum 25 (OH) D in the range of 50 - 100 nmol/L (defined as lowered vitamin D status, or hypovitaminosis D) and 71% with levels in the range of 25 - 50 nmol/L (defined as vitamin D insufficiency) compared to 87% and 11% Chinese women respectively. Serum 25 (OH) D was found to significantly correlate with BMI, fat mass and PTH level. Multivariate analyses showed that race has a strong association with vitamin D status. The high prevalence of inadequate levels of serum vitamin D found in our study may have important public health consequences and warrants the development of a strategy to correct this problem in the older adult Malaysian population.

The effect of milk supplementation on bone mineral density in postmenopausal Chinese women in Malaysia.

Dietary studies often report low calcium intake amongst post-menopausal Malaysian women and calcium deficiency has been implicated as part of the etiology of age-related bone loss leading to osteoporosis. Therefore, the objective of this study was to examine the effectiveness of high calcium skimmed milk (Anlene Gold, New Zealand Milk, Wellington, New Zealand) to reduce bone loss in Chinese postmenopausal women. Two hundred subjects aged 55-65 years and who were more than 5 years postmenopausal were randomized to a milk group and control group. The milk group consumed 50 g of high calcium skimmed milk powder daily, which contained 1200 mg calcium (taken as two glasses of milk a day). The control group continued with their usual diet. Using repeated measures ANCOVA, the milk supplement was found to significantly reduce the percentage of bone loss at the total body compared to the control group at 24 months (control -1.04%, milk -0.13%; P<0.001). At the lumbar spine, the percentage of bone loss in the control group was significantly higher (-0.90%) when compared to the milk (-0.13%) supplemented group at 24 months (P<0.05). Similarly, milk supplementation reduced the percentage of bone loss at the femoral neck (control -1.21%, milk 0.51%) (P<0.01) and total hip (control -2.17%, milk -0.50%) (P<0.01). The supplemented group did not experience any significant weight gain over the 24 months. The serum 25-hydroxy vitamin D level improved significantly (P<0.01) from 69.1 +/- 16.1 nmol/l at baseline to 86.4 +/- 22.0 nmol/l at 24 months in the milk group. In conclusion, ingestion of high calcium skimmed milk was effective in reducing the rate of bone loss at clinically important lumbar spine and hip sites in postmenopausal Chinese women in Malaysia. Supplementing with milk had additional benefits of improving the serum 25-hydroxy vitamin D status of the subjects.

Dietary calcium intake in postmenopausal Malaysian women: comparison between the food frequency questionnaire and three-day food records.

The objective of this study was to compare the dietary calcium intakes assessed by a quantitative food frequency questionnaire (FFQ) and the three-day food record method in 230 Chinese postmenopausal women aged 50-65 years in Kuala Lumpur. The results showed that the mean calcium intake from the dietary records was 447+/-168 mg/day and 499+/-211 mg/day from the FFQ. The mean difference in intake by the two methods was 51.3 mg (95% CI = -30.8-77.9; SD = 181.2, P>0.05), which did not differ significantly from zero. Pearson's correlation coefficient of 0.56 was obtained between the two methods. Ninety-five percent of the individuals classified by food records fell into the same or within-one-quartile category when classified by FFQ. Forty-eight percent were classified into the same quartile by both methods. No subjects were grossly misclassified by the FFQ. The FFQ correctly identified subjects with calcium intakes below the Malaysian recommended daily allowance (450 mg/day) with 60% specificity and with 92% specificity for women consuming less than 800 mg calcium/day. In conclusion, the FFQ developed was a useful, rapid clinical tool for assessing calcium intake and identifying postmenopausal Chinese women with low calcium intakes in Malaysia.