Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial).

INTRODUCTION: Obese men with prostate cancer have an increased risk of biochemical recurrence, metastatic disease and mortality. For those undergoing androgen deprivation therapy (ADT), substantial increases in fat mass are observed in the first year of treatment. Recently, we showed that a targeted supervised clinic-based exercise and nutrition intervention can result in a substantial reduction in fat mass with muscle mass preserved in ADT-treated patients. However, the intervention needs to be accessible to all patients and not just those who can access a supervised clinic-based programme. The purpose of this study was to evaluate the efficacy of telehealth delivered compared with supervised clinic-based delivered exercise and nutrition intervention in overweight/obese patients with prostate cancer. METHODS AND ANALYSIS: A single-blinded, two-arm parallel group, non-inferiority randomised trial will be undertaken with 104 overweight/obese men with prostate cancer (body fat percentage ≥25%) randomly allocated in a ratio of 1:1 to a telehealth-delivered, virtually supervised exercise and nutrition programme or a clinic-based, face-to-face supervised exercise and nutrition programme. Exercise will consist of supervised resistance and aerobic exercise performed three times a week plus additional self-directed aerobic exercise performed 4 days/week for the first 6 months. Thereafter, for months 7-12, the programmes will be self-managed. The primary endpoint will be fat mass. Secondary endpoints include lean mass and abdominal aortic calcification, anthropometric measures and blood pressure assessment, objective measures of physical function and physical activity levels, patient-reported outcomes and blood markers. Measurements will be undertaken at baseline, 6 months (post intervention), and at 12 months of follow-up. Data will be analysed using intention-to-treat and per protocol approaches. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Edith Cowan University Human Research Ethics Committee (ID: 2021-02157-GALVAO). Outcomes from the study will be published in academic journals and presented in scientific and consumer meetings. TRIAL REGISTRATION NUMBER: ACTRN12621001312831.

Development and validation of a food frequency questionnaire to assess omega-3 long chain polyunsaturated fatty acid intake in Australian children aged 9-13 years.

BACKGROUND: The present study aimed to develop a food frequency questionnaire (FFQ) assessing dietary omega-3 long chain polyunsaturated fatty acid (n-3 LCPUFA) intake in Australian children and to validate the FFQ against a 7-day food diary. METHODS: The investigation comprised a cross-sectional and validation study. The study setting was two private primary schools in the in the Illawarra region of New South Wales. Twenty-two Australian children, aged 9-13 years, who were not on a special diet or receiving medical care that limited their food choice in the 3 months prior to recruitment, were recruited into the study. RESULTS: A total of 131 items, classified according to seven food group categories, was included in the n-3 LCPUFA FFQ, as identified from published dietary surveys and a supermarket survey. Good correlations between the FFQ and the 7-day food diary were observed for eicosapentaenoic acid (EPA) [r = 0.691, 95% confidence interval (CI) = 0.51-0.83, P < 0.001], docosahexaenoic acid (DHA) (r = 0.684, 95% CI = 0.45-0.84, P < 0.001) and total n-3 LCPUFA (r = 0.687, 95% CI = 0.48-0.85, P < 0.001). Bland-Altman plots showed an acceptable limit of agreement between the FFQ and the average 7-day food diary. However, the mean EPA, DHA and total n-3 LCPUFA intakes estimated from the FFQ were significantly higher than those from the average 7-day food diary estimates (P < 0.001). CONCLUSIONS: A novel n-3 LCPUFA FFQ that has been developed to estimate dietary n-3 LCPUFA intakes in Australian children has been shown to have relative validity. The FFQ provides a useful contribution to dietary assessment methodology in this age group; however, reproducibility remains to be demonstrated.

Dairy product consumption, dietary nutrient and energy density and associations with obesity in Australian adolescents.

BACKGROUND: Dairy intake is likely to influence dietary energy density (ED) and nutrient density (ND), which are factors representing aspects of dietary quality. Although evidence suggests dairy intake is unlikely to contribute to obesity, intake tends to decrease over adolescence, potentially as a result of concerns around weight gain. We examined associations between dairy intake, ED and ND, and investigated relationships with obesity in adolescents. METHODS: The present study comprised a cross-sectional study of 1613 14-year-olds in the Western Australian Pregnancy Cohort (Raine) Study. Adolescents completed a 212-item food frequency questionnaire. Nutrient Rich Food index 9.3 (NRF9.3) was used to estimate ND. Age-specific body mass index (BMI) and waist-height cut-offs were used to categorise obesity risk. RESULTS: Mean (SD) dairy intake was: 2.62 (1.51) servings daily; ED was 4.53 (0.83) (food and beverage) and 6.28 (1.33) (food only); ND was 373 (109). Dairy intake was inversely associated with ED and positively associated with ND. The odds of being overweight (as assessed by BMI) increased by 1.24 (95% confidence interval = 1.09-1.42) with each 100-point increase in ND, after adjustment for potential confounders and energy intake. ED measures and dairy intake were inversely associated with obesity after adjustment for confounders; associations became nonsignificant after energy adjustment. CONCLUSIONS: The NRF9.3 was originally designed to assess foods, not diets. Further research in other cohorts to determine whether similar findings exist, or investigations into alternate measures of dietary ND, may prove useful. Our findings may be the result of factors such as an excess consumption of refined but fortified foods. Although higher dairy intakes were associated with higher ND, intakes were not associated with higher obesity risk.

Dietary glycaemic carbohydrate in relation to the metabolic syndrome in adolescents: comparison of different metabolic syndrome definitions.

AIMS: High dietary glycaemic carbohydrate, as measured by the dietary glycaemic index and glycaemic load has been associated with increased risk of the metabolic syndrome in adults, but limited research exists for younger populations. We aimed to evaluate associations between dietary glycaemic carbohydrate and insulin resistance or the prevalence of the metabolic syndrome defined by three different criteria in a population-based adolescent cohort. METHODS: Diet was assessed using 3 day food records in 769 adolescents aged 13-15 years participating in the Western Australian Pregnancy Cohort (Raine) Study. The metabolic syndrome was identified using age-specific adolescent definitions from the International Diabetes Federation, the National Cholesterol Education Program Adult Treatment Panel III and a population-derived 'high-risk' metabolic cluster algorithm. Presence of a high waist circumference was mandatory only in the International Diabetes Federation definition. Insulin resistance was measured using homeostasis model assessment (HOMA-IR). RESULTS: The prevalence of the metabolic syndrome as defined by the International Diabetes Federation and the Adult Treatment Panel III was 3.6 and 4.0%, respectively; 25.9% of subjects were classified into the high-risk cluster. Significantly increased odds of International Diabetes Federation-defined metabolic syndrome were independently associated with a 20 unit glycaemic load increase (odds ratio 2.18; 95% confidence interval 1.26-3.78) and a 30 g carbohydrate increase (odds ratio 3.86; 95% confidence interval 1.80-8.28). No significant associations were observed when using the Adult Treatment Panel III, or the cluster-defined metabolic syndrome, or with HOMA-IR. CONCLUSIONS: This study supports the concept that high dietary glycaemic carbohydrate is associated with a higher prevalence of the metabolic syndrome in adolescents. However, relationships vary according to the definition of the metabolic syndrome used, with waist circumference a potentially relevant factor.

Glycaemic load is associated with insulin resistance in older Australian women.

BACKGROUND/OBJECTIVES: Diets with a high postprandial glycaemic response may contribute to the long-term development of insulin resistance and diabetes; however, earlier epidemiological studies are conflicting on whether glycaemic index (GI) or glycaemic load (GL) are dietary factors associated with the progression. Our objectives were to estimate GI and GL in a group of older women, and evaluate cross-sectional associations with insulin resistance. SUBJECTS/METHODS: The subjects were 329 Australian women aged 42-81 years participating in year 3 of the Longitudinal Assessment of Ageing in Women study. Dietary intakes were assessed by diet history interviews and analysed using a customized GI database. Insulin resistance was defined as a homeostasis model assessment value of >3.99, based on fasting blood glucose and insulin concentrations. RESULTS: GL was significantly higher in the 26 subjects who were classified as insulin resistant compared with subjects who were not (134+/-33 versus 114+/-24, P<0.001). In a logistic regression model, an increment of 15 GL units increased the odds of insulin resistance by 2.09 (95% confidence interval (1.55, 2.80), P<0.001) independently of potential confounding variables. No significant associations were found when insulin resistance was assessed as a continuous variable. CONCLUSIONS: The results of this cross-sectional study support the concept that diets with a higher GL are associated with an increased risk of insulin resistance. Further studies are required to determine whether reducing the glycaemic intake, either by consuming lower GI foods or through smaller serves of carbohydrate, can contribute to a reduction in development of insulin resistance and long-term risk of type II diabetes.

Associations between the use of complementary and alternative medications and demographic, health and lifestyle factors in mid-life Australian women.

OBJECTIVE: To determine the prevalence and types of complementary and alternative medications (CAMs) used by menopausal women living in South-East Queensland, Australia; and profile the women who are using CAMs through sociodemographic characteristics, self-rated health status, lifestyle and preventative health strategies. METHOD: This study was a secondary data analysis of data collected by postal questionnaire from 886 women aged 48-67 years participating in the Queensland Midlife Women's Health Study. The outcome measure was CAM use, distinguished by three categories: herbal therapies, phytoestrogens and nutritional intake (supplements and healthy eating). RESULTS: The overall prevalence of CAM use among mid-life Australian women was 82% which included therapeutic techniques (83%), nutritional supplements (66.8%), phytoestrogens (55.8%), herbal therapies (41.3%), Evening Primrose oil (34%) and vitamin E (28.8%). CAM users, when compared to non-users, were more likely to be previous (p < 0.05) but not current users (p < 0.05) of hormone therapy (HT), higher educated (p < 0.05), low to middle income earners (p < 0.001) and have participated in self-breast examination (p < 0.01). They were also more likely to report good general health (p < 0.05) and improved physical functioning without limitations due to health (p < 0.05). CAM users were less likely to be aged over 55 years (p < 0.05) and smoke more than 20 cigarettes per day (p < 0.001). CONCLUSIONS/IMPLICATIONS FOR HEALTH RESEARCH: As prevalence of current CAM use in this population group is considerably higher than HT use, health education programs to assist mid-life women to understand the scientific evidence (or lack of it) for their efficacy is recommended.

Urinary isoflavonoid excretion is inversely associated with the ratio of protein to dietary fibre intake in young women.

OBJECTIVE: To examine the prevalence of excretion of urinary isoflavonoids in women and determine any relationships with accustomed macronutrient intake. DESIGN: Volunteers in one of two 4-month studies. Study 1 was a randomised crossover study whereby subjects consumed a placebo or isoflavone supplement for 2 months and crossed over. Study 2 was a parallel design in which subjects consumed a placebo for 1 month and an isoflavone supplement for 3 months. SETTING: All subjects were free-living, healthy volunteers. SUBJECTS: A total of 25 (study 1, n=14; study 2, n=11) premenopausal women were recruited through advertisements. INTERVENTIONS: Volunteers were supplemented for 2 months (study 1) or 3 months (study 2) with purified isoflavones (86 mg/day) derived from red clover. Urinary isoflavonoids were measured during the placebo and the second month of isoflavone treatment. Macronutrient intakes were determined from weighed food records. RESULTS: During isoflavone supplementation, the concentration of urinary total isoflavonoids increased by 15-fold (P<0.0001), with 5.4-fold variation between individuals. Multiple linear regression analysis showed that 24% of this variation could be explained by an interaction between dietary fibre and protein (P=0.047), with a highly significant inverse association between total isoflavonoid concentration and the protein to fibre ratio (r=-0.51, P=0.009). CONCLUSIONS: Supplementation with purified isoflavones results in an increase in urinary isoflavonoid excretion and part of the individual variation in response is associated with an interaction between intakes of protein and dietary fibre. Whether manipulation of these macronutrients could enhance efficacy of isoflavone supplements remains to be determined.

The effect of supplementation with isoflavones on plasma lipids and oxidisability of low density lipoprotein in premenopausal women.

Results of recent clinical studies have lead to the hypothesis that isoflavones are cardioprotective. The aims of this trial were to determine the effect of supplementation with isoflavonoid phytoestrogens on plasma cholesterol concentrations and its distribution among lipoproteins and whether supplementation with isoflavones influences oxidisability of low density lipoprotein (LDL) ex vivo. Fourteen healthy premenopausal women participated in a randomised cross-over trial lasting four menstrual cycles (approximately 4 months). The subjects were asked to consume 86 mg of isoflavones daily for the duration of two menstrual cycles followed by placebo for an equivalent period, or vice versa. Venous blood samples were collected initially and at the end of the second and fourth menstrual cycles for the determination of plasma lipid concentrations and the resistance of LDL to copper-induced oxidation ex vivo. Accustomed dietary intake of isoflavones and lignans during the placebo period were 6.87+/-3.0 and 1.80+/-0.22 mg/day (mean+/-S.E.M.), respectively, and these did not change during the supplementation period. The intake of other dietary components remained constant during the trial. Supplementation resulted in a 5-fold increase in urinary isoflavone excretion (12.2+/-14.2 versus 70.1+/-10.3 micromol/24 h, placebo and isoflavone periods, respectively, P=0.0001). No changes in the oxidisability of LDL (lag time of 32.9+/-3.1 versus 30.4+/-2.9 min) or the plasma concentrations of total cholesterol (4.03+/-0.21 versus 4.11+/-0.18 mmol/l) or triacylglycerol (0.67+/-0.04 versus 0.73+/-0.06 mmol/l) were observed following supplementation. However a significant period effect (P=0.024) was observed and a trend towards a carryover effect (P=0.086) was noted for the concentration of HDL(3) cholesterol. Further studies are required to clarify the potential effect of isoflavones on HDL metabolism and the interaction with plasma steroid hormones during the menstrual cycle.

The nutritional and metabolic effects of boron in humans and animals.

We have undertaken studies in humans and animals that aimed to obtain further information about the intake and excretion of boron (B) as well as its effects on markers of coronary heart disease. In humans, we have shown that the intake of B is 2.2 mg/d; its urinary excretion is 1.9 mg/d, and there appears to be little intraindividual variation. Supplementation with 10 mg of B/d resulted in the recovery of 84% of the dose in the urine and a significant increase in plasma estradiol concentration, but no effect on plasma lipoproteins. In rats, increasing the intake of B through the drinking water is reflected in the tissue concentrations, results in an increase in plasma testosterone and vitamin D, and results in a decrease in HDL cholesterol. It is clear that B has the potential to impact significantly on a number of metabolic processes.

High sugar intake in a group of women on methadone maintenance in south western Sydney, Australia.

Nutritional assessment comprising dietary and anthropometric measurements was conducted in a group of 86 women attending a methadone maintenance clinic in South Western Sydney, Australia. Dietary data were obtained by two 24-hour recall interviews using a standardized interview format. Nutrient intake was analysed using the NUTTAB data base of Australian foods (1992). Mean age of the sample was 29.8 (range 18-46) years and mean body mass index was 22.7 (range 16.2-43.4) kg/m2. The diet of the study group was characterized by a low energy intake of 6.48 MF (95% CI 6.02-6.94), a high sugars intake of 122 g (95% CI 112-132), a high percentage of total energy (31%, 95% CI 29-32) derived from sugars, and a low dietary fibre intake of 10.7 g (95% CI 9.7-12.3). This eating pattern may contribute to the high prevalence of a dental caries and chronic constipation observed in the group. The results pattern also support anecdotal evidence of a craving for sweetness described by addicts. Despite the low energy intake, body mass indices of the group were no different from the normal population. It is possible that 2 days' intake was insufficient to accurately measure accustomed diet in this group of women. Alternatively, the low intake may be a consequence of their largely sedentary life-styles.

Increase of high-density lipoprotein cholesterol at ovulation in healthy women.

Plasma cholesterol is believed to vary more in women than in men, with the menstrual cycle, yet our review of the literature found no consistent pattern. We examined variations in plasma lipoproteins in relation to ovarian hormones in 12 healthy, menstruating women. Twenty fasting blood samples were obtained on alternate days over one menstrual cycle; ovulation was timed by hormone measurements. Plasma was analysed enzymatically for total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and triacylglycerol (TAG). Low-density lipoprotein cholesterol (LDL-C) was estimated by the Friedewald formula. The greatest effect was seen in HDL-C. Concentrations increased by 12% (P < 0.001) between the times of menstruation and ovulation and remained elevated until the following premenstrual phase. The height of peak oestradiol concentrations at ovulation was significantly associated with HDL-C in that phase (r = +0.75, P < 0.01), and with mean HDL-C concentrations over the whole cycle (r = +0.65, P < 0.05). TC and LDL-C also increased at ovulation, by 9% (P < 0.005) and 11% (P < 0.025) respectively, although the effect was more transient. This study demonstrates that consistent changes in plasma lipoproteins do occur during the menstrual cycle.