Effects of very low-carbohydrate vs. high-carbohydrate weight loss diets on psychological health in adults with obesity and type 2 diabetes: a 2-year randomized controlled trial.

AIMS: Very low-carbohydrate (LC) diets are popular for type 2 diabetes (T2DM) management; however, long-term effects on psychological health remain largely unknown. This study reports the effects of a LC diet on mood and cognitive function after 2 years and explores the potential predictors of changes in psychological health. METHODS: 115 adults (57% males; age: 58.5 ± 7.1 years) with obesity and T2DM were randomized to consume an energy reduced (~ 500 to 1000 kcal/day deficit), LC diet [14% energy as carbohydrate, 28% protein, 58% fat (< 10% saturated fat)] or an isocaloric high unrefined carbohydrate, low-fat diet [HC: 53% carbohydrate, 17% protein, 30% fat (< 10% saturated fat)] for 2 years. Both diets were combined with aerobic/resistance exercise (1 h, 3 days/week). Mood/well-being [Beck Depression Inventory (BDI), Spielberger State Anxiety Inventory (SAI), Profile of Mood States (POMS)], diabetes-related quality of life [Diabetes-39 (D-39)] and distress [Problem Areas in Diabetes (PAID) Questionnaire], and cognitive function were assessed during and post-intervention. RESULTS: 61 (LC: 33, HC: 28) participants completed the study. Weight loss was 9.1% after 12 months and 6.7% after 2 years with no difference between diet groups. There were no differences between the groups for the changes in any psychological health outcome (smallest p ≥ 0.19 for all time x diet interactions). Overtime, improvements in BDI, POMS [Total Mood Disturbance (TMD); four subscales], PAID, and D-39 (three subscales) scores occurred (p ≤ 0.05, time). Stepwise regression analysis showed improvements in BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores were significantly (p < 0.05) correlated with reductions in body weight and glycated hemoglobin. CONCLUSION: In adults with obesity and T2DM, energy-restricted LC and HC diets produced comparable long-term improvements on a comprehensive range of psychological health outcomes. The findings suggest both diets can be used as a diabetes management strategy as part of a holistic lifestyle modification program without concern of negative effects on mental well-being or cognition. TRIAL REGISTRATION: ACTRN12612000369820, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362168&isReview=true . Data described in the manuscript, code book, and analytic code will not be made available because approval has not been granted by participants.

The Effects of Vitamin D-Enriched Mushrooms and Vitamin D3 on Cognitive Performance and Mood in Healthy Elderly Adults: A Randomised, Double-Blinded, Placebo-Controlled Trial.

Despite abundant cross-sectional evidence that low vitamin D status is associated with risk of cognitive decline in ageing, interventional evidence for benefits of vitamin D supplementation is lacking. This study was a 6 month randomised, double-blinded placebo-controlled clinical trial of the effects of vitamin D3 (D3), enhanced vitamin D2 in a mushroom matrix (D2M), standard mushroom (SM) and placebo (PL) on cognition and mood in n = 436 healthy older male (49%) and female volunteers aged ≥ 60 years. Primary end points were change in serum vitamin D metabolites (25-OH-D, 25-OH-D2 and 25-OH-D3), cognitive performance, and mood over 24 weeks. Levels of total 25-OH-D and 25-OH-D3 were maintained in the D3 arm but decreased significantly (p < 0.05) in the remaining arms (D2M, SM and PL). Analysis also revealed differential changes in these metabolites depending on total vitamin D status at baseline. There were no significant effects of treatment on any of the measures of cognitive function or mood. Overall, the results show that daily supplementation of ~600 IU of vitamin D3 was sufficient to maintain 25-OH-D throughout winter months, but in contrast to existing cross-sectional studies there was no support for benefit of vitamin D supplementation for mood or cognition in healthy elderly people.

Nutritional adequacy of very low- and high-carbohydrate, low saturated fat diets in adults with type 2 diabetes: A secondary analysis of a 2-year randomised controlled trial.

BACKGROUND: Growing evidence supports use of very low-carbohydrate (LC) diets for glycaemic control in type 2 diabetes. However, limited data on the micronutrient adequacy of LC diets exist. OBJECTIVE: This study compared the long-term effects of a very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet on micronutrient biomarkers in adults with obesity and type 2 diabetes. METHODS: 115 adults with type 2 diabetes (mean[SD]; BMI:34.6[4.3]kg/m2, age:58[7]yrs, HbA1c:7.3[1.1]%, 56[12]mmol/mol) were randomized to one of two planned, nutritionally-replete, energy-matched, hypocaloric diets (500-1000 kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat]) for 2 years. Nutritional biomarkers- folate, ß-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation were measured in fasting blood at baseline, 24, 52 and 104 weeks. RESULTS: 61 participants completed the study with similar dropouts in each group (P = 0.40). For all biomarkers assessed, there were no differential response between groups overtime (P ≥ 0.17 time × diet interaction). Mean vitamin and mineral levels remained within normal (laboratory-specific) reference ranges without any reported cases of clinical deficiencies. CONCLUSION: In free-living individuals with type 2 diabetes, nutrition biomarkers within normal ranges at baseline did not change significantly after 2 years on a prescribed LC or HC diet. These results demonstrate the feasibility of delivering a nutritionally replete LC diet and the importance of considering nutritional factors in planning LC diets that have strong public health relevance to the dietary management of type 2 diabetes. TRIAL REGISTRATION: http://www.anzctr.org.au/, ANZCTR No. ACTRN12612000369820.

Correction to: Comparison of the effects of weight loss from a high-protein versus standard-protein energy-restricted diet on strength and aerobic capacity in overweight and obese men.

The original version of this article unfortunately contained a mistake.

Altering meal timing to improve cognitive performance during simulated nightshifts.

Altering meal timing could improve cognition, alertness, and thus safety during the nightshift. This study investigated the differential impact of consuming a meal, snack, or not eating during the nightshift on cognitive performance (ANZCTR12615001107516). 39 healthy participants (59% male, age mean±SD: 24.5 ± 5.0y) completed a 7-day laboratory study and underwent four simulated nightshifts. Participants were randomly allocated to: Meal at Night (MN; n= 12), Snack at Night (SN; n = 13) or No Eating at Night (NE; n = 14). At 00:30 h, MN consumed a meal and SN consumed a snack (30% and 10% of 24 h energy intake respectively). NE did not eat during the nightshift. Macronutrient intake was constant across conditions. At 20:00 h, 22:30 h, 01:30 h, and 04:00 h, participants completed the 3-min Psychomotor Vigilance Task (PVT-B), 40-min driving simulator, post-drive PVT-B, subjective sleepiness scale, 2-choice Reaction Time task, and Running Memory task. Objective sleep was recorded for each of the day sleeps using Actigraphy and for the third day sleep, Polysomnography was used. Performance was compared between conditions using mixed model analyses. Significant two-way interactions were found. At 04:00 h, SN displayed increased time spent in the safe zone (p < .001; percentage of time spent within 10 km/h of the speed limit and 0.8 m of lane center), and decreases in speed variability (p < .001), lane variability (p < .001), post-drive PVT-B lapses (defined as RT > 355 ms; p < .001), and reaction time on the 2-choice reaction time task (p < .001) and running memory task (p < .001) compared to MN and NE. MN reported greater subjective sleepiness at 04:00 h (p < .001) compared to SN and NE. There was no difference in objective sleep between eating conditions. Eating a large meal during the nightshift impairs cognitive performance and sleepiness above the effects of time of night alone. For improved performance, shiftworkers should opt for a snack at night.

A Mobile Phone App Designed to Support Weight Loss Maintenance and Well-Being (MotiMate): Randomized Controlled Trial.

BACKGROUND: Few people successfully maintain lost weight over the longer term. Mobile phones have the potential to deliver weight loss management programs that can encourage self-monitoring while also providing some behavioral therapy to assist users in developing personal skills that may be necessary for improved longer term weight loss maintenance. OBJECTIVE: The aim of this study was to evaluate a program supporting weight maintenance, which uses a behaviorally based mobile phone app to manage weight, food, exercise, mood, and stress. METHODS: In a randomized controlled trial over 24 weeks, the full version of the app (MotiMate) was compared with a control app (monitoring only; excluding mood and stress) for its effect on weight, diet, and psychological well-being. Both apps had the same visual appearance and were designed to deliver all intervention content without face-to-face contact. The control version included features to track weight, food intake, and exercise with limited feedback and no encouraging/persuasive features. The intervention app included more persuasive and interactive features to help users track their weight, food intake, and physical activity and prompted users to enter data each day through notifications and included a mood and stress workshopping tool. Participants were recruited through advertising and existing databases. Clinic visits occurred at baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. At all visits, the clinical trial manager recorded body weight, and participants then completed a computer-delivered survey, which measured psychological and lifestyle outcomes. Objective app usage data were recorded throughout the trial. RESULTS: A total of 88 adults who had lost and maintained at least 5% of their body weight within the last 2 years were randomized (45 MotiMate and 43 control). Overall, 75% (66/88) were female, and 69% (61/88) completed week 24 with no differences in dropout by condition (χ21,87=0.7, P=.49). Mixed models suggested no significant changes in weight or psychological outcomes over 24 weeks regardless of condition. Of 61 completers, 53% (32/61) remained within 2% of their starting weight. Significant increases occurred over 24 weeks for satisfaction with life and weight loss self-efficacy regardless of app condition. Diet and physical activity behaviors did not vary by app or week. Negative binomial models indicated that those receiving the full app remained active users of the app for 46 days longer than controls (P=.02). Users of the full version of the app also reported that they felt more supported than those with the control app (P=.01). CONCLUSIONS: Although some aspects of the intervention app such as usage and user feedback showed promise, there were few observable effects on behavioral and psychological outcomes. Future evaluation of the app should implement alternative research methods or target more specific populations to better understand the utility of the coping interface. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry ACTRN12614000474651; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366120.

Subjective Hunger, Gastric Upset, and Sleepiness in Response to Altered Meal Timing during Simulated Shiftwork.

Shiftworkers report eating during the night when the body is primed to sleep. This study investigated the impact of altering food timing on subjective responses. Healthy participants (n = 44, 26 male, age Mean ± SD = 25.0 ± 2.9 years, BMI = 23.82 ± 2.59kg/m2) participated in a 7-day simulated shiftwork protocol. Participants were randomly allocated to one of three eating conditions. At 00:30, participants consumed a meal comprising 30% of 24 h energy intake (Meal condition; n = 14, 8 males), a snack comprising 10% of 24 h energy intake (Snack condition; n = 14; 8 males) or did not eat during the night (No Eating condition; n = 16, 10 males). Total 24 h individual energy intake and macronutrient content was constant across conditions. During the night, participants reported hunger, gut reaction, and sleepiness levels at 21:00, 23:30, 2:30, and 5:00. Mixed model analyses revealed that the snack condition reported significantly more hunger than the meal group (p < 0.001) with the no eating at night group reporting the greatest hunger (p < 0.001). There was no difference in desire to eat between meal and snack groups. Participants reported less sleepiness after the snack compared to after the meal (p < 0.001) or when not eating during the night (p < 0.001). Gastric upset did not differ between conditions. A snack during the nightshift could alleviate hunger during the nightshift without causing fullness or increased sleepiness.

Predictors of Lifestyle Intervention Attrition or Weight Loss Success in Women with Polycystic Ovary Syndrome Who Are Overweight or Obese.

Background/objectives: Polycystic ovary syndrome (PCOS) is a common condition in reproductive-aged women. Weight management is a first-line treatment for PCOS according to international evidence-based guidelines. However, the factors associated with attrition or success in weight loss interventions are not known for women with PCOS. The objective of this study was to identify characteristics associated with attrition and weight loss success in women with PCOS and overweight or obesity undergoing weight loss interventions. Methods: Four randomised controlled clinical weight loss trials comprising energy restricted diets and/or exercise interventions of 2⁻8 months duration. The interventions were conducted over 2001⁻2007 in outpatient clinical research centres with n = 221 premenopausal women with PCOS and overweight/obesity recruited through community advertisement. The main outcome measures were attrition and ≥5% weight loss at 2 months and study completion. Results: Weight loss was 5.7 ± 2.9 kg at 2 months and 7.4 ± 5.3 kg after study completion (p < 0.001). Attrition was 47.1% and ≥5% weight loss occurred in 62.5% and 62.7% of women at 2 months and study completion respectively. Baseline depressive symptoms (OR 1.07 95% CI 0.88, 0.96, p = 0.032) and lower appointment attendance by 2 months (OR 0.92 95% CI 0.88, 0.96, p < 0.001) were independently associated with attrition. Lower appointment attendance over the whole study was independently associated with not achieving ≥5% weight loss at study completion (OR 0.95 95% CI 0.92, 0.99, p = 0.020). Conclusions: Despite high attrition, successful weight loss was achieved by 63% of women with PCOS in a clinical research setting. Higher baseline depressive symptoms were associated with greater attrition and higher appointment attendance was associated with lower attrition and greater weight loss success. These finding have implications for development of successful weight management programs in PCOS.

A mixed-methods investigation of psychological factors relevant to weight maintenance.

This study investigated perceptions of and engagement with the concepts of planning and problem-solving, within a weight management sample. A total of 53 participants (62% female, 20-74 years old) completed a semi-structured interview and quantitative measures after a 16-week weight maintenance period. Preliminary weight maintainers (who had maintained losses of, at least 10% of their original weight) were compared with heavier-than-baseline participants (who had re-gained more weight than was originally lost). The maintainers exhibited stronger problem-solving skills ( p < .05). The heavier-than-baseline participants tended towards non-rational problem-solving styles. Qualitatively, the maintainers described more planning events and were more accepting of mistakes than the heavier-than-baseline participants. Implications are discussed.

Randomized Trial of a High Protein, Partial Meal Replacement Program with or without Alternate Day Fasting: Similar Effects on Weight Loss, Retention Status, Nutritional, Metabolic, and Behavioral Outcomes.

Higher-protein diets, meal replacements, and greater early weight loss have separately been associated with greater weight loss. We compared a high-protein, meal replacement program with daily energy restriction (DER) to one which provided greater energy restriction adding alternate day fasting (ADF + DER; alternating days of modified-fasting and DER plus 1 ad libitum day/week) on retention, weight loss, physiological, nutritional, and behavioral markers. Participants were randomized to ADF + DER or DER for 16 weeks (n = 162, age 40 ± 8 years BMI 36 ± 6 kg/m² (Mean ± SD)) plus 8 weeks weight maintenance. At week 16 weight change was -10.7 ± 0.5 kg and -11.2 ± 0.6 kg in ADF + DER and DER groups (treatment NS). Fat mass, visceral adipose tissue, and lean mass (p < 0.05) were similarly reduced between treatments. Weight loss was sustained to 24 weeks (treatment NS). Fasting LDL-cholesterol, triglycerides, insulin, hsCRP, glucose, and blood pressure all improved (p < 0.05; treatment NS). Transferrin saturation, ferritin, serum zinc, folate, and B12 improved (p < 0.05; treatment NS). Plasma thiamine and vitamin D levels decreased, reflecting lower carbohydrate intakes and seasonal changes, respectively. Food cravings, quality of life, and mood improved (treatment NS). Energy, fatigue, and pain improved slightly more in DER (p < 0.05). This study supports the use of higher protein, meal replacement programs with or without ADF in weight management.

Reductions in food cravings are similar with low-fat weight loss diets differing in protein and carbohydrate in overweight and obese adults with type 2 diabetes: A randomized clinical trial.

Food cravings are common in type 2 diabetes (T2D). Higher-protein diets are effective in improving satiety but their effect on cravings is unclear. It was hypothesized that a high protein (HP) diet would provide greater reductions in cravings than an isocaloric higher-carbohydrate diet (HC). In a randomized controlled trial, 61 adults (54% males) with T2D (means ± SD: BMI 34.3 ± 5.1 kg/m2; aged 55 ± 8 years) consumed either a HP diet (mean across study: 29% protein, 34% carbohydrate, 31% fat) or an isocaloric HC diet (21%:48%:24%) for 12-weeks each of weight loss (WL) and weight maintenance (WM). The Food Craving Inventory (FCI), measuring types of foods craved and the General Food Craving Questionnaires measuring traits (G-FCQ-T) and states (G-FCQ-S) were assessed at Weeks 0, 12 and 24. Weight changes were similar between groups (means ± SEM: WL: -7.8 ± 0.6 kg, WM: -0.6 ± 0.4 kg). No group effects or group x time interactions were found for any outcome (P ≥ .07). Independent of group, all food cravings (except carbohydrates) and G-FCQ-T subscales decreased over the 24-week study (P ≤ .04) with sweets and fast food cravings, loss of control and emotional cravings reducing following WL (P ≤ .03). Obsessive preoccupation with food decreased following both phases (WL: P = .03; WM: P = .001). Weight was associated with several FCI subscales (r ≥ 0.24, P ≤ .04). In conclusion, both the HP and HC diets provided significant reductions in food cravings after similar weight losses which were maintained when weight was stabilized.

Preventing chronic disease in patients with low health literacy using eHealth and teamwork in primary healthcare: protocol for a cluster randomised controlled trial.

INTRODUCTION: Adults with lower levels of health literacy are less likely to engage in health-promoting behaviours. Our trial evaluates the impacts and outcomes of a mobile health-enhanced preventive intervention in primary care for people who are overweight or obese. METHODS AND ANALYSIS: A two-arm pragmatic practice-level cluster randomised trial will be conducted in 40 practices in low socioeconomic areas in Sydney and Adelaide, Australia. Forty patients aged 40-70 years with a body mass index ≥28 kg/m2 will be enrolled per practice. The HeLP-general practitioner (GP) intervention includes a practice-level quality improvement intervention (medical record audit and feedback, staff training and practice facilitation visits) to support practices to implement the clinical intervention for patients. The clinical intervention involves a health check visit with a practice nurse based on the 5As framework (assess, advise, agree, assist and arrange), the use of a purpose-built patient-facing app, my snapp, and referral for telephone coaching. The primary outcomes are change in health literacy, lifestyle behaviours, weight, waist circumference and blood pressure. The study will also evaluate changes in quality of life and health service use to determine the cost-effectiveness of the intervention and examine the experiences of practices in implementing the programme. ETHICS AND DISSEMINATION: The study has been approved by the University of New South Wales (UNSW) Human Research Ethics Committee (HC17474) and ratified by the University of Adelaide Human Research Ethics committee. There are no restrictions on publication, and findings of the study will be made available to the public via the Centre for Primary Health Care and Equity website and through conference presentations and research publications. Deidentified data and meta-data will be stored in a repository at UNSW and made available subject to ethics committee approval. TRIAL REGISTRATIONREGISTRATION NUMBER: ACTRN12617001508369; Pre-results.

Comparison of two low-fat diets, differing in protein and carbohydrate, on psychological wellbeing in adults with obesity and type 2 diabetes: a randomised clinical trial.

BACKGROUND: Although higher-protein diets (HP) can assist with weight loss and glycemic control, their effect on psychological wellbeing has not been established. The objective of this study was to compare the effects of a HP and a higher-carbohydrate diet (HC), combined with regular exercise, on psychological wellbeing both during weight loss (WL) and weight maintenance phases (WM). METHODS: In a parallel RCT, 61 adults with T2D (mean ± SD: BMI 34.3 ± 5.1 kg/m2, aged 55 ± 8 years) consumed a HP diet (29% protein, 34% carbohydrate, 31% fat) or an isocaloric HC diet (21%:48%:24%), with moderate intensity exercise, for 12 weeks of WL and 12 weeks of WM. Secondary data evaluating psychological wellbeing was assessed using: Problems Areas in Diabetes (PAID); Diabetes-39 Quality of Life (D-39); Short Form Health Survey (SF-36); Perceived Stress Scale-10 (PSS-10) and the Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 0, 12 and 24 and evaluated with mixed models analysis. RESULTS: Independent of diet, improvements for PAID; D-39 diabetes control; D-39 severity of diabetes; SF-36 physical functioning and SF-36 general health were found following WL (d = 0.30 to 0.69, P ≤ 0.04 for all) which remained after 12 weeks of WM. SF-36 vitality improved more in the HP group (group x time interaction P = 0.03). Associations were seen between HbA1c and D-39 severity of diabetes rating (r = 0.30, P = 0.01) and SF-36 mental health (r = - 0.32, P = 0.003) and between weight loss and PAID (r = 0.30, P = 0.01). CONCLUSION: Several improvements in diabetes-related and general psychological wellbeing were seen similarly for both diets following weight loss and a reduction in HbA1c with most of these improvements remaining when weight loss was sustained for 12 weeks. A HP diet may provide additional increases in vitality. TRIAL REGISTRATION: The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12613000008729 ) on 4 January 2013.

Adjustment Factors Can Improve Estimates of Food Group Intake Assessed Using a Short Dietary Assessment Instrument.

BACKGROUND: Methods to address misreporting associated with short dietary assessment instruments are needed. OBJECTIVE: Our objective was to develop and evaluate the direct and indirect validity of adjustment factors applied to a short dietary assessment instrument to improve estimates of usual consumption of core and discretionary food and beverage intake. DESIGN: Validation of the Short Food Survey relative to 24-hour recalls was performed. The Short Food Survey requires individuals to report their usual intake of fruit, vegetables, grains, meat, dairy, and discretionary choices in multiples of standard servings. Adjustment factors were developed based on a ratio (usual portion size estimated from national data to standard serving size). The estimates of food group intakes (unadjusted and adjusted) were compared to 24-hour recalls. PARTICIPANTS/SETTING: Three population samples were used in this study. The direct validation used data from 61 Australian adults (collected 2013-2014). The indirect validation compared data from the 2011-2013 Australian National Nutrition and Physical Activity Survey (n=9,435) to a sample of 145,975 who completed the Short Food Survey in a format that is freely available online (2015-2016). MAIN OUTCOME MEASURES: Food group intake (in servings) was measured. STATISTICAL ANALYSES PERFORMED: Descriptive and inferential statistical analyses were conducted. RESULTS: Direct validation showed the adjustment factors improved the survey-derived estimates of intake for all food groups except grain foods. For grains, the mean difference went from -0.6 servings to +1.2 to 1.5 servings. The absolute difference in food group intake between the adjusted Short Food Survey and recalls remained statistically significant for fruit, meat, dairy, and grains, but was not different for vegetables and discretionary foods. The indirect validation showed that the adjusted estimates of intake from the online Short Food Survey were closer to the population estimates reported by 24-hour recall for all food groups except meat. CONCLUSIONS: Adjustment factors can improve estimates of food group intake assessed using a short dietary assessment instrument for some but not all food groups.

Plant sterols lower LDL-cholesterol and triglycerides in dyslipidemic individuals with or at risk of developing type 2 diabetes; a randomized, double-blind, placebo-controlled study.

BACKGROUND: Managing cardiovascular disease (CVD) risk factors, e.g., dyslipidemia in type-2 diabetes mellitus (T2DM) is critically important as CVD is the most common cause of death in T2DM patients. This study aimed to investigate the effect of plant sterols (PS) on lowering both elevated low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG). METHODS: In a double-blind, randomized, placebo-controlled, parallel study, 161 individuals at increased risk of and with established T2DM, consumed low-fat spreads without or with added PS (2 g/d) for 6 weeks after a 2-week run-in period. Increased risk of developing T2DM was defined by the Australian T2DM Risk Assessment Tool (AUSDRISK). Fasting serum/plasma total cholesterol (TC), LDL-C, TG, high-density lipoprotein cholesterol (HDL-C), glucose and insulin were measured at baseline and after 6 weeks. Effects on acute and chronic postprandial blood lipids, glucose and insulin were measured over 4-h in 39 individuals with T2DM following a mixed meal challenge without and with added 2 g/d PS at week 6. The study was registered at clinicaltrials.gov (NCT02288585). RESULTS: Hundred fifty-one individuals completed the study and 138 (57% men, 43% women; 44 with and 94 at risk of T2DM) were included in per protocol analysis. Baseline LDL-C and TG were 3.8 ± 1.0 and 2.5 ± 0.8 mmol/l, respectively. PS intake significantly lowered fasting LDL-C (-4.6%, 95%CI -1.2; -8.0; p = 0.009), TC (-4.2%, 95%CI -1.2; -7.1; p = 0.006) and TG (-8.3%, 95% -1.1, -15.0; p = 0.024) with no significant changes in HDL-C, glucose or insulin. Postprandial lipid (TG, TC, LDL-C, HDL-C, remnant cholesterol), glucose and insulin responses did not differ. CONCLUSIONS: In individuals at risk of and with established T2DM and with elevated TG and LDL-C, 2 g/d of PS results in dual LDL-C plus TG lowering. Postprandial lipid or glycemic responses did not differ between PS and control treatment.

Incorporating a Static Versus Supportive Mobile Phone App Into a Partial Meal Replacement Program With Face-to-Face Support: Randomized Controlled Trial.

BACKGROUND: Mobile phone apps may be acceptable to users and could improve retention and adherence over more traditional methods, but there is mixed literature supporting their efficacy. In the weight management space, very little is known about how a mobile phone app integrating features beyond text messaging (short message service) can affect behavior, particularly when combined with face-to-face support. OBJECTIVE: The objective of this study was to examine the effectiveness of a mobile phone app when combined with a partial meal replacement program including face-to-face support. This paper compares a static versus supportive app over a 6-month randomized trial for effects on weight loss, weight-related biomarkers, and psychological outcomes. METHODS: Overweight and obese adults (71.2% female, 104/146; mean 48.11, SD 11.75 years) were recruited to participate in the weight loss study, and they were randomized on a 1:1 basis using a computer algorithm. The supportive app (n=75) provided information, food intake recording, rewards, prompts for regular interaction through reminders, and the opportunity to review personal compliance with the dietary program. The static app (n=71) included only recipes and weight loss information. Both groups recieved equal amounts of face-to-face support in addition to app. RESULTS: The overall reduction in app usage over 24 weeks was lower for the supportive app in comparison with the static app; approximately 39.0% (57/146) of the users were still using the app at week 24. Despite the promising results for app usage, there were no differences in weight loss between groups (F1,128.12=0.83, P=.36). However, it should be noted that almost 60% (49/84) of all participants lost 5% or more of body weight during the trial. No weight-related biomarkers were significantly different between groups. Both groups experienced an increase in positive mood, but this was significantly higher for those who received the static app (F1,118.12=4.93, P=.03). CONCLUSIONS: Although the supportive app was well received by users, we found little evidence of the added benefit of this versus the static app in combination with face-to-face support in a community-delivered weight loss program. Future versions of the app may incorporate more unique behavioral techniques beyond those provided by the consultant to improve the potency of the app. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000547741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364187 (Archived by WebCite http://www.webcitation.org/6yivwfMI9).

Compliance with Dietary Guidelines Varies by Weight Status: A Cross-Sectional Study of Australian Adults.

Population surveys have rarely identified dietary patterns associated with excess energy intake in relation to risk of obesity. This study uses self-reported food intake data from the validated Commonwealth Scientific and Industrial Research Organisation (CSIRO) Healthy Diet Score survey to examine whether apparent compliance with dietary guidelines varies by weight status. The sample of 185,951 Australian adults were majority female (71.8%), with 30.2%, 35.3% and 31.0% aged between 18-30, 31-50 and 51-70 years respectively. Using multinomial regression, in the adjusted model controlling for gender and age, individuals in the lowest quintile of diet quality were almost three times more likely to be obese than those in the highest quintile (OR 2.99, CI: 2.88:3.11; p < 0.001). The differential components of diet quality between normal and obese adults were fruit (difference in compliance score 12.9 points out of a possible 100, CI: 12.3:13.5; p < 0.001), discretionary foods (8.7 points, CI: 8.1:9.2; p < 0.001), and healthy fats (7.7 points, CI: 7.2:8.1; p < 0.001). Discretionary foods was the lowest scoring component across all gender and weight status groups, and are an important intervention target to improve diet quality. This study contributes to the evidence that diet quality is associated with health outcomes, including weight status, and will be useful in framing recommendations for obesity prevention and management.

Association between dietary patterns, cadmium intake and chronic kidney disease among adults.

BACKGROUND & AIMS: Almost one in ten Chinese adults has chronic kidney disease (CKD). However, the link between dietary patterns, dietary cadmium intake and CKD has not been studied in China. METHOD: Adults (n = 8429) in the China Health and Nutrition Survey who had at least one 3-day 24 h food record in combination with household food inventory in 1991, 1993, 1997, 2000, 2004, 2006, and 2009 and estimated glomerular filtration rate (eGFR) measured in 2009. Dietary pattern was identified using factor analysis. CKD was defined as eGFR <60 mL/min/1.73 m2. RESULTS: There were 641 (7.6%) cases of CKD in the sample. After adjustment for demographic, lifestyle factors (i.e. smoking, alcohol drinking, physical activity) and chronic conditions, the odds ratio (OR) for CKD was 4.05 (95%CI 2.91-5.63, p for trend <0.001) for extreme quartiles of estimated cumulative cadmium intake. A traditional southern dietary pattern (high intake of rice, pork, and vegetables, and low intake of wheat) was associated with more than four times increased prevalence of CKD (comparing extreme quartiles, OR 4.56, 95%CI 3.18-6.56). A modern dietary pattern (high intake of fruit, soy milk, egg, milk and deep fried products) was inversely associated with CKD (for extreme quartiles, OR 0.5, 95%CI 0.36-0.71). The association between dietary patterns and CKD were attenuated by cadmium intake. CONCLUSION: Traditional southern dietary pattern is positively associated, and modern dietary pattern is inversely associated, with CKD among Chinese adults. However, these associations can be partly attributed to cadmium contamination in parts of the food supply.

Effects of an energy-restricted low-carbohydrate, high unsaturated fat/low saturated fat diet versus a high-carbohydrate, low-fat diet in type 2 diabetes: A 2-year randomized clinical trial.

AIM: To examine whether a low-carbohydrate, high-unsaturated/low-saturated fat diet (LC) improves glycaemic control and cardiovascular disease (CVD) risk factors in overweight and obese patients with type 2 diabetes (T2D). METHODS: A total of 115 adults with T2D (mean [SD]; BMI, 34.6 [4.3] kg/m2 ; age, 58 [7] years; HbA1c, 7.3 [1.1]%) were randomized to 1 of 2 planned energy-matched, hypocaloric diets combined with aerobic/resistance exercise (1 hour, 3 days/week) for 2 years: LC: 14% energy as carbohydrate, 28% as protein, 58% as fat (<10% saturated fat); or low-fat, high-carbohydrate, low-glycaemic index diet (HC): 53% as CHO, 17% as protein, 30% as fat (<10% saturated fat). HbA1c, glycaemic variability (GV), anti-glycaemic medication effect score (MES, calculated based on the potency and dosage of diabetes medication), weight, body composition, CVD and renal risk markers were assessed before and after intervention. RESULTS: A total of 61 (LC = 33, HC = 28) participants completed the study (trial registration: http://www.anzctr.org.au/, ANZCTR No. ACTRN12612000369820). Reductions in weight (estimated marginal mean [95% CI]; LC, -6.8 [-8.8,-4.7], HC, -6.6 [-8.8, -4.5] kg), body fat (LC, -4.3 [-6.2, -2.4], HC, -4.6 [-6.6, -2.7] kg), blood pressure (LC, -2.0 [-5.9, 1.8]/ -1.2 [-3.6, 1.2], HC, -3.2 [-7.3, 0.9]/ -2.0 [-4.5, 0.5] mmHg), HbA1c (LC, -0.6 [-0.9, -0.3], HC, -0.9 [-1.2, -0.5] %) and fasting glucose (LC, 0.3 [-0.4, 1.0], HC, -0.4 [-1.1, 0.4] mmol/L) were similar between groups (P ≥ 0.09). Compared to HC, the LC achieved greater reductions in diabetes medication use (MES; LC, -0.5 [-0.6, -0.3], HC, -0.2 [-0.4, -0.02] units; P = 0.03), GV (Continuous Overall Net Glycemic Action calculated every 1 hour (LC, -0.4 [-0.6, -0.3], HC, -0.1 [-0.1, 0.2] mmol/L; P = 0.001), and 4 hours (LC, -0.9 [-1.3, -0.6], HC, -0.2 [-0.6, 0.1] mmol/L; P = 0.02)); triglycerides (LC, -0.1 [-0.3, 0.2], HC, 0.1 [-0.2, 0.3] mmol/L; P = 0.001), and maintained HDL-C levels (LC, 0.02 [-0.05, 0.1], HC, -0.1 [-0.1, 0.01] mmol/L; P = 0.004), but had similar changes in LDL-C (LC, 0.2 [-0.1, 0.5], HC, 0.1 [-0.2, 0.4] mmol/L; P = 0.85), brachial artery flow mediated dilatation (LC, -0.5 [-1.5, 0.5], HC, -0.4 [-1.4, 0.7] %; P = 0.73), eGFR and albuminuria. CONCLUSIONS: Both diets achieved comparable weight loss and HbA1c reductions. The LC sustained greater reductions in diabetes medication requirements, and in improvements in diurnal blood glucose stability and blood lipid profile, with no adverse renal effects, suggesting greater optimization of T2D management.