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Effects of low-carbohydrate diets versus low-fat diets on metabolic risk factors in overweight and obese adults: A meta-analysis of randomized controlled trials.
Lei, L, Huang, J, Zhang, L, Hong, Y, Hui, S, Yang, J
Frontiers in nutrition. 2022;9:935234
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Low carbohydrate diets (LCD) and Low-fat diets (LFD) have both been shown to aid weight loss, however comparisons of the two have shown inconsistent results. This systematic review and meta-analysis of 33 studies involving 3939 individuals aimed to compare the effects of LFD and LCD on metabolic risk factors and weight loss. The results showed that compared with LFD, individuals on LCD had a greater reduction in fat circulating around the body, blood pressure, weight, and a greater increase in good cholesterol in the short-term. However, individuals on LFD had a greater decrease in bad cholesterol. In the long-term the benefits were the same for both diets. It was concluded that in the short-term LCD and LFD may have specific effects on body morphology and chemistry however over longer periods of time the benefits are similar. This study could be used by healthcare professionals to understand that different diets should be recommended to achieve different outcomes.
Abstract
BACKGROUND AND AIMS Low-carbohydrate diets (LCD) and low-fat diets (LFD) have shown beneficial effects on the management of obesity. Epidemiological studies were conducted to compare the effects of the two diets. However, the results were not always consistent. This study aimed to conduct a meta-analysis to compare the long-term effects of LCD and LFD on metabolic risk factors and weight loss in overweight and obese adults. METHODS We performed a systematic literature search up to 30 March, 2022 in PubMed, EMBASE, and Cochrane Library. The meta-analysis compared the effects of LCD (carbohydrate intake ≤ 40%) with LFD (fat intake < 30%) on metabolic risk factors and weight loss for ≥6 months. Subgroup analyses were performed based on participant characteristics, dietary energy intake, and the proportions of carbohydrates. RESULTS 33 studies involving a total of 3,939 participants were included. Compared with participants on LFD, participants on LCD had a greater reduction in triglycerides (-0.14 mmol/L; 95% CI, -0.18 to -0.10 mmol/L), diastolic blood pressure (-0.87 mmHg; 95% CI, -1.41 to -0.32 mmHg), weight loss (-1.33 kg; 95% CI, -1.79 to -0.87 kg), and a greater increase in high-density lipoprotein cholesterol (0.07 mmol/L; 95% CI, 0.06 to 0.09 mmol/L) in 6-23 months. However, the decrease of total cholesterol (0.14 mmol/L; 95% CI, 0.07 to 0.20 mmol/L) and low-density lipoprotein cholesterol (0.10 mmol/L; 95% CI, 0.06 to 0.14 mmol/L) was more conducive to LFD in 6-23 months. There was no difference in benefits between the two diets after 24 months. Subgroup analyses showed no significant difference in the reduction of total cholesterol, low-density lipoprotein cholesterol, and blood pressure between the two diets in participants with diabetes, hypertension, or hyperlipidemia. CONCLUSION The results suggest that LCD and LFD may have specific effects on metabolic risk factors and weight loss in overweight and obese adults over 6 months. At 24 months, the effects on weight loss and improvement of metabolic risk factors were at least the same. These indicated that we might choose different diets to manage the overweight and obese subjects. However, the long-term clinical efficacy and effects of various sources of carbohydrates or fat in the two diets need to be studied in the future.
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Mining microbes for mental health: Determining the role of microbial metabolic pathways in human brain health and disease.
Spichak, S, Bastiaanssen, TFS, Berding, K, Vlckova, K, Clarke, G, Dinan, TG, Cryan, JF
Neuroscience and biobehavioral reviews. 2021;125:698-761
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The microbiota-gut-brain axis is an emerging area of focus for mental health and disease. Metabolic products from gut microbiota exert direct and indirect effects on the brain through various body systems. The aim of this study was to review the evidence on these metabolic pathways and utilise new predictive tools to assess metabolic signatures of various disease states. This review included 278 studies and, despite the weak evidence, identified new links between gut microbial metabolic pathways in schizophrenia, Alzheimer’s disease, and anxiety and depression. The authors conclude this review provides a novel approach for understanding the mechanisms behind the bidirectional communication between the gut and brain. They also suggest guidelines for analysing and interpreting metadata of human-microbiome-brain studies and provide a framework for better understanding these metabolic pathways in relation to the brain.
Abstract
There is increasing knowledge regarding the role of the microbiome in modulating the brain and behaviour. Indeed, the actions of microbial metabolites are key for appropriate gut-brain communication in humans. Among these metabolites, short-chain fatty acids, tryptophan, and bile acid metabolites/pathways show strong preclinical evidence for involvement in various aspects of brain function and behaviour. With the identification of neuroactive gut-brain modules, new predictive tools can be applied to existing datasets. We identified 278 studies relating to the human microbiota-gut-brain axis which included sequencing data. This spanned across psychiatric and neurological disorders with a small number also focused on normal behavioural development. With a consistent bioinformatics pipeline, thirty-five of these datasets were reanalysed from publicly available raw sequencing files and the remainder summarised and collated. Among the reanalysed studies, we uncovered evidence of disease-related alterations in microbial metabolic pathways in Alzheimer's Disease, schizophrenia, anxiety and depression. Amongst studies that could not be reanalysed, many sequencing and technical limitations hindered the discovery of specific biomarkers of microbes or metabolites conserved across studies. Future studies are warranted to confirm our findings. We also propose guidelines for future human microbiome analysis to increase reproducibility and consistency within the field.
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Nutraceutical approach for the management of cardiovascular risk - a combination containing the probiotic Bifidobacterium longum BB536 and red yeast rice extract: results from a randomized, double-blind, placebo-controlled study.
Ruscica, M, Pavanello, C, Gandini, S, Macchi, C, Botta, M, Dall'Orto, D, Del Puppo, M, Bertolotti, M, Bosisio, R, Mombelli, G, et al
Nutrition journal. 2019;18(1):13
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Probiotics have been shown to reduce total cholesterol (TC) and low-density lipoprotein (LDL-C – often called ‘bad’ cholesterol) in people with moderately raised cholesterol levels. A specific strain of probiotic called Bifidobacterium longum BB536, may decrease TC and LDL-C by reducing the reabsorption of cholesterol from the intestine, and, combined with other natural supplements, may be useful to manage high cholesterol in people at low risk of heart disease. This study was conducted to evaluate the effect of a nutraceutical (Lactoflorene Colesterolo®), containing Bifidobacterium longum BB536 (1bn CFUs) combined with red yeast rice (RYR) extract (10 mg/day monacolin K), niacin (16mg) and coenzyme Q10 (20mg) on levels of cholesterol and fats in the blood. This was a 12-week randomised, parallel, double-blind, placebo-controlled study, in which 33 adults at low risk of heart disease were given either the Bifidobacterium combination, or a placebo. Treatment with the Bifidobacterium combination significantly reduced total cholesterol by 16.7%, LDL-C by 25.7%, non-HDL-C by 24% and apolipoprotein-B by 17%. Triglycerides, HDL-C, apolipoprotein AI, lipoprotein (a) and proprotein convertase subtilisin/kexin type 9 (PCSK9) were unchanged. Markers of cholesterol synthesis and absorption suggested that a reduction in the synthesis of cholesterol had occurred without increased absorption of cholesterol. No adverse effects were reported in the study and the compliance rate was high at 97%. The use of nutraceuticals in the prevention of cardiovascular disease, as well as in other areas related to chronic diseases like cancer, is currently expanding.
Abstract
BACKGROUND Probiotics incorporated into dairy products have been shown to reduce total (TC) and LDL cholesterolemia (LDL-C) in subjects with moderate hypercholesterolemia. More specifically, probiotics with high biliary salt hydrolase activity, e.g. Bifidobacterium longum BB536, may decrease TC and LDL-C by lowering intestinal cholesterol reabsorption and, combined with other nutraceuticals, may be useful to manage hypercholesterolemia in subjects with low cardiovascular (CV) risk. This study was conducted to evaluate the efficacy and safety of a nutraceutical combination containing Bifidobacterium longum BB536, red yeast rice (RYR) extract (10 mg/day monacolin K), niacin, coenzyme Q10 (Lactoflorene Colesterolo®). The end-points were changes of lipid CV risk markers (LDL-C, TC, non-HDL-cholesterol (HDL-C), triglycerides (TG), apolipoprotein B (ApoB), HDL-C, apolipoprotein AI (ApoAI), lipoprotein(a) (Lp(a), proprotein convertase subtilisin/kexin type 9 (PCSK9)), and of markers of cholesterol synthesis/absorption. METHODS A 12-week randomized, parallel, double-blind, placebo-controlled study. Thirty-three subjects (18-70 years) in primary CV prevention and low CV risk (SCORE 0-1% in 24 and 2-4% in 9 subjects; LDL-C: 130-200 mg/dL) were randomly allocated to either nutraceutical (N = 16) or placebo (N = 17). RESULTS Twelve-week treatment with the nutraceutical combination, compared to placebo, significantly reduced TC (- 16.7%), LDL-C (- 25.7%), non-HDL-C (- 24%) (all p < 0.0001), apoB (- 17%, p = 0.003). TG, HDL-C, apoAI, Lp(a), PCSK9 were unchanged. Lathosterol:TC ratio was significantly reduced by the nutraceutical combination, while campesterol:TC ratio and sitosterol:TC ratio did not change, suggesting reduction of synthesis without increased absorption of cholesterol. No adverse effects and a 97% compliance were observed. CONCLUSIONS A 12-week treatment with a nutraceutical combination containing the probiotic Bifidobacterium longum BB536 and RYR extract significantly improved the atherogenic lipid profile and was well tolerated by low CV risk subjects. TRIAL REGISTRATION NCT02689934 .
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Effect of yerba mate and green tea on paraoxonase and leptin levels in patients affected by overweight or obesity and dyslipidemia: a randomized clinical trial.
Balsan, G, Pellanda, LC, Sausen, G, Galarraga, T, Zaffari, D, Pontin, B, Portal, VL
Nutrition journal. 2019;18(1):5
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Yerba mate is a popular tea-like beverage, traditionally consumed in Latin and South America. Yerba mate contains a range of plant compounds that may have beneficial effects on health, such as weight loss and antioxidant activity. This study aimed to evaluate the effect of the intake of yerba mate and green tea on serum levels of leptin, a hormone involved in regulating appetite, and paraoxonase-1 (PON-1), an enzyme that can destroy harmful oxidised fats in the blood. 142 overweight or obese adults aged 35-60 years, with abnormal levels of fats in the blood and no history of coronary artery disease took part in this controlled, randomised clinical trial. Participants drank 1 litre of either yerba mate, green tea or apple tea daily for eight weeks. Blood PON-1 and leptin levels were measured at the beginning and end of the study. The group drinking yerba mate showed a significant 9.7% increase in blood levels of PON-1, but no difference in leptin levels. The consumption of green tea resulted in no significant differences in the levels of PON-1 or leptin. The increase in PON-1 levels in the yerba mate group was significantly associated with increased levels of high-density lipoprotein (HDL-c - often called ‘good’ cholesterol). The authors concluded that drinking yerba mate increased antioxidant capacity by increasing blood levels of PON-1 and was positively associated with increased HDL-c, demonstrating a protective role of this beverage against thickening and hardening of the arteries.
Abstract
BACKGROUND This study aimed to evaluate the effect of the intake of yerba mate (YM) and green tea (GT) on serum levels of leptin and paraoxonase-1 (PON-1), compared to control. METHODS Controlled, randomized clinical trial (RCT) that evaluated 142 men and women affected by overweight or obesity aged 35-60 years, untreated dyslipidemia and no history of coronary artery disease. Participants were randomized to ingest 1000 mL GT, YM or apple tea (AT, control group) daily, during eight weeks. Serum PON-1 and leptin levels were analyzed by ELISA immunoassay at the beginning (baseline) and after eight weeks of intervention. RESULTS The intake of 1 l of YM/day resulted in significant increase in serum levels of PON-1 (9.7%; p = 0.005). The consumption of GT induced no significant difference in the levels of PON-1 (p = 0.154) and leptin (p = 0.783). Intergroup analysis showed a significant difference (p = 0.036) in the variation of PON-1 levels in the YM group when compared to GT and AT groups. In addition, the increase in PON-1 levels in the YM group was significantly associated with increased HDL-c (p = 0.004). CONCLUSIONS The intake of yerba mate increased the antioxidant capacity by increasing serum levels of PON-1 and was positively associated with increased HDL-c, stressing the protective role of this beverage against atherosclerotic diseases. GT intake had no significant effect on serum levels of PON-1 and leptin. TRIAL REGISTRATION This study is registered with ClinicalTrials.gov under protocol number NCT00933647.
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Intermittent Fasting in Cardiovascular Disorders-An Overview.
Malinowski, B, Zalewska, K, Węsierska, A, Sokołowska, MM, Socha, M, Liczner, G, Pawlak-Osińska, K, Wiciński, M
Nutrients. 2019;11(3)
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Intermittent fasting (IF) is an eating pattern that cycles between periods of fasting and eating. IF has gained popularity in recent years with people wanting to lose weight, and it may have many long-term health benefits. In this review, the authors looked at human and animal studies using variations of IF including time restricted eating (TRE), where eating is confined within a specific window during the day (for example 8 hours eating and 16 hours fasting), and alternate day fasting (ADF), where a day of eating normally is alternated with a day of either fasting entirely, or significant calorie restriction. The authors found that IF is related to many beneficial effects on the cardiovascular system, involving atherosclerosis progression, benefits for diabetes mellitus type 2 such as improved glucose metabolism and insulin sensitivity, lowering of blood pressure, and other cardiovascular risk factors (such as lipid profile and inflammation). It is currently unclear whether the benefits of IF are solely due to weight loss or other mechanisms. The success of every type of diet depends on compliance, and IF seems to be as easy or easier to follow than more traditional diets for many people. Fasting is not recommended for people with hormonal imbalances, pregnant and breastfeeding women, and diabetics. People with eating disorders and underweight people are also not recommended to use the intermittent fasting diet. In recent years, the IF diet and its varieties have become increasingly popular. This diet not only serves to reduce body weight but seems to have other long-term health benefits. However, individuals’ current health and situation should be considered before commencing the IF diet.
Abstract
Intermittent fasting is a form of time restricted eating (typically 16 h fasting and 8 h eating), which has gained popularity in recent years and shows promise as a possible new paradigm in the approach to weight loss and the reduction of inflammation, and has many potential long term health benefits. In this review, the authors will incorporate many aspects of fasting, mainly focusing on its effects on the cardiovascular system, involving atherosclerosis progression, benefits for diabetes mellitus type 2, lowering of blood pressure, and exploring other cardiovascular risk factors (such as lipid profile and inflammation).
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Associations of dietary intake with cardiometabolic risk in a multi-ethnic cohort: a longitudinal analysis of the Determinants of Adolescence, now young Adults, Social well-being and Health (DASH) study.
Goff, LM, Huang, P, Silva, MJ, Bordoli, C, Enayat, EZ, Molaodi, OR, Cassidy, A, Maynard, M, Harding, S
The British journal of nutrition. 2019;121(9):1069-1079
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Ethnic inequalities in a wide range of chronic diseases are well documented. Poor dietary habits in childhood may contribute to higher rates of chronic diseases such as type 2 diabetes (T2D), hypertension and Coronary Heart Disease (CHD). This study was a longitudinal follow-up of a subsample of the Determinants of Adolescent Social well-being and Health (DASH) study. The researchers aimed to identify dietary patterns and investigate their impact on chronic diseases in young adulthood. The study participants were 107 White British, 102 Black Caribbean, 132 Black African, 98 Indian, 111 Bangladeshi/Pakistani and 115 other/mixed ethnicity. Participants completed a 24-hour dietary intake recall and behaviour questionnaire at age 11-13yrs, and then again at age 21-23yrs. Body mass index (BMI), blood pressure, blood cholesterol and blood sugar were measured. The researchers found that dietary behaviours such as skipping breakfast and a low intake of fruit and vegetables were common. Rates of skipping breakfast and low fruit and vegetable consumption were highest among Black African and Black Caribbean participants. BMI and cholesterol levels in young adults were higher among those who regularly skipped breakfast. The researchers concluded that skipping breakfast is more common in certain ethnic groups and is associated with risk factors for chronic disease in young adults. They suggest that interventions to improve dietary habits could be targeted at specific population groups.
Abstract
Unfavourable dietary habits, such as skipping breakfast, are common among ethnic minority children and may contribute to inequalities in cardiometabolic disease. We conducted a longitudinal follow-up of a subsample of the UK multi-ethnic Determinants of Adolescent Social well-being and Health cohort, which represents the main UK ethnic groups and is now aged 21-23 years. We aimed to describe longitudinal patterns of dietary intake and investigate their impact on cardiometabolic risk in young adulthood. Participants completed a dietary behaviour questionnaire and a 24 h dietary intake recall; anthropometry, blood pressure, total cholesterol and HDL-cholesterol and HbA1c were measured. The cohort consisted of 107 White British, 102 Black Caribbean, 132 Black African, 98 Indian, 111 Bangladeshi/Pakistani and 115 other/mixed ethnicity. Unhealthful dietary behaviours such as skipping breakfast and low intake of fruits and vegetables were common (56, 57 and 63 %, respectively). Rates of skipping breakfast and low fruit and vegetable consumption were highest among Black African and Black Caribbean participants. BMI and cholesterol levels at 21-23 years were higher among those who regularly skipped breakfast at 11-13 years (BMI 1·41 (95 % CI 0·57, 2·26), P=0·001; cholesterol 0·15 (95 % CI -0·01, 0·31), P=0·063) and at 21-23 years (BMI 1·05 (95 % CI 0·22, 1·89), P=0·014; cholesterol 0·22 (95 % CI 0·06, 0·37), P=0·007). Childhood breakfast skipping is more common in certain ethnic groups and is associated with cardiometabolic risk factors in young adulthood. Our findings highlight the importance of targeting interventions to improve dietary behaviours such as breakfast consumption at specific population groups.
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Lifestyle and vascular risk effects on MRI-based biomarkers of Alzheimer's disease: a cross-sectional study of middle-aged adults from the broader New York City area.
Mosconi, L, Walters, M, Sterling, J, Quinn, C, McHugh, P, Andrews, RE, Matthews, DC, Ganzer, C, Osorio, RS, Isaacson, RS, et al
BMJ open. 2018;8(3):e019362
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Alzheimer’s disease (AD) is the most common form of dementia, affecting nearly 34 million people worldwide. It has been estimated that one in every three cases of AD may be attributable to diet and lifestyle factors. The aim of this study was to investigate the effects of lifestyle and vascular-related risk factors for AD. Researchers studied the brain scans of 116 healthy adults aged 30-60 years. They collected information on factors related to lifestyle, such as diet, physical activity and intellectual enrichment. They also looked at markers for vascular risk such as body mass index (BMI), cholesterol and homocysteine, as well as cognitive function. The researchers found that a Mediterranean-style diet and good insulin sensitivity were both associated with a healthier brain structure. A better score for intellectual enrichment and lower BMI were both associated with better cognition. They concluded that adopting a Mediterranean-style diet and maintaining a healthy weight might reduce the risk of developing AD.
Abstract
OBJECTIVE To investigate the effects of lifestyle and vascular-related risk factors for Alzheimer's disease (AD) on in vivo MRI-based brain atrophy in asymptomatic young to middle-aged adults. DESIGN Cross-sectional, observational. SETTING Broader New York City area. Two research centres affiliated with the Alzheimer's disease Core Center at New York University School of Medicine. PARTICIPANTS We studied 116 cognitively normal healthy research participants aged 30-60 years, who completed a three-dimensional T1-weighted volumetric MRI and had lifestyle (diet, physical activity and intellectual enrichment), vascular risk (overweight, hypertension, insulin resistance, elevated cholesterol and homocysteine) and cognition (memory, executive function, language) data. Estimates of cortical thickness for entorhinal (EC), posterior cingulate, orbitofrontal, inferior and middle temporal cortex were obtained by use of automated segmentation tools. We applied confirmatory factor analysis and structural equation modelling to evaluate the associations between lifestyle, vascular risk, brain and cognition. RESULTS Adherence to a Mediterranean-style diet (MeDi) and insulin sensitivity were both positively associated with MRI-based cortical thickness (diet: βs≥0.26, insulin sensitivity βs≥0.58, P≤0.008). After accounting for vascular risk, EC in turn explained variance in memory (P≤0.001). None of the other lifestyle and vascular risk variables were associated with brain thickness. In addition, the path associations between intellectual enrichment and better cognition were significant (βs≥0.25 P≤0.001), as were those between overweight and lower cognition (βs≥-0.22, P≤0.01). CONCLUSIONS In cognitively normal middle-aged adults, MeDi and insulin sensitivity explained cortical thickness in key brain regions for AD, and EC thickness predicted memory performance in turn. Intellectual activity and overweight were associated with cognitive performance through different pathways. Our findings support further investigation of lifestyle and vascular risk factor modification against brain ageing and AD. More studies with larger samples are needed to replicate these research findings in more diverse, community-based settings.
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Dietary Cholesterol and the Lack of Evidence in Cardiovascular Disease.
Soliman, GA
Nutrients. 2018;10(6)
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For years, dietary cholesterol was implicated in increasing blood cholesterol levels, therefore contributing to the development of cardiovascular disease (CVD). While it is known that saturated fatty acids and trans-fatty acids increase CVD risk, the evidence of dietary cholesterol increasing this risk remains inconclusive. This review summarises the current evidence regarding dietary cholesterol, blood cholesterol, saturated fatty acids and the risk of CVD. This review found that the current literature does not support the notion that dietary cholesterol increases the risk of heart disease in healthy individuals. The fact that dietary cholesterol is common in foods that are high in saturated fats may have contributed to the hypothesis that dietary cholesterol increases the risk of CVD. Based on these results, the author suggests individuals incorporate nutrient-dense, calorie controlled, balanced meals in eating patterns.
Abstract
Cardiovascular disease (CVD) is the leading cause of death in the United States. For years, dietary cholesterol was implicated in increasing blood cholesterol levels leading to the elevated risk of CVD. To date, extensive research did not show evidence to support a role of dietary cholesterol in the development of CVD. As a result, the 2015⁻2020 Dietary Guidelines for Americans removed the recommendations of restricting dietary cholesterol to 300 mg/day. This review summarizes the current literature regarding dietary cholesterol intake and CVD. It is worth noting that most foods that are rich in cholesterol are also high in saturated fatty acids and thus may increase the risk of CVD due to the saturated fatty acid content. The exceptions are eggs and shrimp. Considering that eggs are affordable and nutrient-dense food items, containing high-quality protein with minimal saturated fatty acids (1.56 gm/egg) and are rich in several micronutrients including vitamins and minerals, it would be worthwhile to include eggs in moderation as a part of a healthy eating pattern. This recommendation is particularly relevant when individual’s intakes of nutrients are suboptimal, or with limited income and food access, and to help ensure dietary intake of sufficient nutrients in growing children and older adults.
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Structured lifestyle education to support weight loss for people with schizophrenia, schizoaffective disorder and first episode psychosis: the STEPWISE RCT.
Holt, RI, Hind, D, Gossage-Worrall, R, Bradburn, MJ, Saxon, D, McCrone, P, Morris, TA, Etherington, A, Shiers, D, Barnard, K, et al
Health technology assessment (Winchester, England). 2018;22(65):1-160
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People with schizophrenia are often overweight. Losing weight and being more active can reduce the risk of type 2 diabetes mellitus, heart disease and dying early. The NHS recommends offering a weight loss programme; however, mental health care providers do not know the best way to do this. This study assessed whether an education programme to help people with psychosis to lose weight would be better than the usual care provided by the NHS. A total of 414 people took part. Half were selected at random to attend an education programme run by trained facilitators. The other half received their usual health care. The researchers found no difference in weight between the two groups, at either 3 months or 12 months. They also found that the programme did not provide good value for money. In interviews, service users said that they liked the education programme and that it helped them to eat healthily and lose weight. However, there was no change in their diet and activity levels in either group. Unfortunately, although some people benefited, the programme did not work for most people. The researchers concluded that they need to look for better ways to help people with psychosis to lose weight.
Abstract
BACKGROUND Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. OBJECTIVES To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. DESIGN A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost-utility analysis. SETTING Ten community mental health trusts in England. PARTICIPANTS People with first episode psychosis, schizophrenia or schizoaffective disorder. INTERVENTIONS Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. MAIN OUTCOME MEASURES The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. RESULTS The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval -1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants' behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. CONCLUSIONS Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. TRIAL REGISTRATION Current Controlled Trials ISRCTN19447796. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.
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Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial.
Trepanowski, JF, Kroeger, CM, Barnosky, A, Klempel, MC, Bhutani, S, Hoddy, KK, Gabel, K, Freels, S, Rigdon, J, Rood, J, et al
JAMA internal medicine. 2017;177(7):930-938
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Restricting calories every second day to as low as 500 calories (alternate day fasting) has become popular in recent years as a weight loss strategy. This randomised clinical trial of 69 obese, but otherwise healthy, individuals aimed to assess the impact of alternate day fasting for 6 months on weight loss and risk factors for heart disease, in comparison to more traditional daily calorie restriction. The study results showed that average weight loss was similar for the alternate day fasting group and daily calorie restriction group, compared to control. Average HDL cholesterol levels were higher at month 6 and average LDL cholesterol levels were higher at month 12 in the alternate day fasting group, compared to the daily calorie restriction group. There were no other statistically significant differences between the 2 groups for other markers of heart disease. Drop out rates were highest in the alternate day fasting group, suggesting that it is a harder diet to stick to in the longer term. Nutrition practitioners practising individualised nutrition can use the results of this trial to work with overweight clients in choosing the best dietary strategy for weight loss in relation to their clients’ goals and lifestyle.
Abstract
Importance: Alternate-day fasting has become increasingly popular, yet, to date, no long-term randomized clinical trials have evaluated its efficacy. Objective: To compare the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease. Design, Setting, and Participants: A single-center randomized clinical trial of obese adults (18 to 64 years of age; mean body mass index, 34) was conducted between October 1, 2011, and January 15, 2015, at an academic institution in Chicago, Illinois. Interventions: Participants were randomized to 1 of 3 groups for 1 year: alternate-day fasting (25% of energy needs on fast days; 125% of energy needs on alternating "feast days"), calorie restriction (75% of energy needs every day), or a no-intervention control. The trial involved a 6-month weight-loss phase followed by a 6-month weight-maintenance phase. Main Outcomes and Measures: The primary outcome was change in body weight. Secondary outcomes were adherence to the dietary intervention and risk indicators for cardiovascular disease. Results: Among the 100 participants (86 women and 14 men; mean [SD] age, 44 [11] years), the dropout rate was highest in the alternate-day fasting group (13 of 34 [38%]), vs the daily calorie restriction group (10 of 35 [29%]) and control group (8 of 31 [26%]). Mean weight loss was similar for participants in the alternate-day fasting group and those in the daily calorie restriction group at month 6 (-6.8% [95% CI, -9.1% to -4.5%] vs -6.8% [95% CI, -9.1% to -4.6%]) and month 12 (-6.0% [95% CI, -8.5% to -3.6%] vs -5.3% [95% CI, -7.6% to -3.0%]) relative to those in the control group. Participants in the alternate-day fasting group ate more than prescribed on fast days, and less than prescribed on feast days, while those in the daily calorie restriction group generally met their prescribed energy goals. There were no significant differences between the intervention groups in blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C-reactive protein, or homocysteine concentrations at month 6 or 12. Mean high-density lipoprotein cholesterol levels at month 6 significantly increased among the participants in the alternate-day fasting group (6.2 mg/dL [95% CI, 0.1-12.4 mg/dL]), but not at month 12 (1.0 mg/dL [95% CI, -5.9 to 7.8 mg/dL]), relative to those in the daily calorie restriction group. Mean low-density lipoprotein cholesterol levels were significantly elevated by month 12 among the participants in the alternate-day fasting group (11.5 mg/dL [95% CI, 1.9-21.1 mg/dL]) compared with those in the daily calorie restriction group. Conclusions and Relevance: Alternate-day fasting did not produce superior adherence, weight loss, weight maintenance, or cardioprotection vs daily calorie restriction. Trial Registration: clinicaltrials.gov Identifier: NCT00960505.