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Effects of Low-Carbohydrate versus Mediterranean Diets on Weight Loss, Glucose Metabolism, Insulin Kinetics and β-Cell Function in Morbidly Obese Individuals.
Tricò, D, Moriconi, D, Berta, R, Baldi, S, Quinones-Galvan, A, Guiducci, L, Taddei, S, Mari, A, Nannipieri, M
Nutrients. 2021;13(4)
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Both low-carbohydrate and Mediterranean style diets are used to prevent lifestyle associated diseases such as obesity and type 2 diabetes. However, which diet is more effective is unclear. The aim of this randomised control trial of 36 morbidly obese individuals was to compare the effectiveness of Mediterranean diets and low-carbohydrate diets to improve metabolic measures such as blood sugar levels, pre-diabetes, and the body’s ability to use sugar. The results showed that in the short-term both diets were equally effective at improving biochemical dysfunctions that contribute to type 2 diabetes. The low-carbohydrate diet did result in higher weight loss than the Mediterranean diet. Studies on long-term effects are warranted. It was concluded that a low-carbohydrate diet is in the short-term a feasible alternative to the Mediterranean diet for improved weight loss and biological contributors to type 2 diabetes. This study could be used by healthcare professionals to understand that the Mediterranean diet and low-carbohydrate diet are both effective in the short-term for improvements to contributors to type 2 diabetes, however the low-carbohydrate diet may be superior if weight loss is required.
Abstract
Low-calorie Mediterranean-style or low-carbohydrate dietary regimens are widely used nutritional strategies against obesity and associated metabolic diseases, including type 2 diabetes. The aim of this study was to compare the effectiveness of a balanced Mediterranean diet with a low-carbohydrate diet on weight loss and glucose homeostasis in morbidly obese individuals at high risk to develop diabetes. Insulin secretion, insulin clearance, and different β-cell function components were estimated by modeling plasma glucose, insulin and C-peptide profiles during 75-g oral glucose tolerance tests (OGTTs) performed at baseline and after 4 weeks of each dietary intervention. The average weight loss was 5%, being 58% greater in the low-carbohydrate-group than Mediterranean-group. Fasting plasma glucose and glucose tolerance were not affected by the diets. The two dietary regimens proved similarly effective in improving insulin resistance and fasting hyperinsulinemia, while enhancing endogenous insulin clearance and β-cell glucose sensitivity. In summary, we demonstrated that a low-carbohydrate diet is a successful short-term approach for weight loss in morbidly obese patients and a feasible alternative to the Mediterranean diet for its glucometabolic benefits, including improvements in insulin resistance, insulin clearance and β-cell function. Further studies are needed to compare the long-term efficacy and safety of the two diets.
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Lipids activate skeletal muscle mitochondrial fission and quality control networks to induce insulin resistance in humans.
Axelrod, CL, Fealy, CE, Erickson, ML, Davuluri, G, Fujioka, H, Dantas, WS, Huang, E, Pergola, K, Mey, JT, King, WT, et al
Metabolism: clinical and experimental. 2021;121:154803
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Insulin resistance is a key pathophysiological mechanism in the development and progression of type 2 diabetes. Abnormalities in lipid metabolism and ectopic lipid accumulation are known to directly contribute to the onset of insulin resistance. Authors hypothesised that lipid infusion would increase dynamin related protein 1 [a type of protein]-mediated mitochondrial fission in skeletal muscle independent of function and content, consequently reducing peripheral insulin sensitivity. The study included sedentary but otherwise healthy adults who were prospectively randomized to receive either lipid or saline infusion to isolate the direct contribution of fatty acids to skeletal muscle mitochondrial dynamics. Results show that mitochondrial fission and quality control networks are activated in response to lipid infusion which occurs independent of changes in mitochondrial content or capacity and contributes to the onset of insulin resistance in healthy humans. Authors conclude that treatments that limit lipid-induced activation of mitochondrial fission and/or quality control processes may have therapeutic value in the treatment of insulin resistance.
Abstract
BACKGROUND AND AIMS A diminution in skeletal muscle mitochondrial function due to ectopic lipid accumulation and excess nutrient intake is thought to contribute to insulin resistance and the development of type 2 diabetes. However, the functional integrity of mitochondria in insulin-resistant skeletal muscle remains highly controversial. METHODS 19 healthy adults (age:28.4 ± 1.7 years; BMI:22.7 ± 0.3 kg/m2) received an overnight intravenous infusion of lipid (20% Intralipid) or saline followed by a hyperinsulinemic-euglycemic clamp to assess insulin sensitivity using a randomized crossover design. Skeletal muscle biopsies were obtained after the overnight lipid infusion to evaluate activation of mitochondrial dynamics proteins, ex-vivo mitochondrial membrane potential, ex-vivo oxidative phosphorylation and electron transfer capacity, and mitochondrial ultrastructure. RESULTS Overnight lipid infusion increased dynamin related protein 1 (DRP1) phosphorylation at serine 616 and PTEN-induced kinase 1 (PINK1) expression (P = 0.003 and P = 0.008, respectively) in skeletal muscle while reducing mitochondrial membrane potential (P = 0.042). The lipid infusion also increased mitochondrial-associated lipid droplet formation (P = 0.011), the number of dilated cristae, and the presence of autophagic vesicles without altering mitochondrial number or respiratory capacity. Additionally, lipid infusion suppressed peripheral glucose disposal (P = 0.004) and hepatic insulin sensitivity (P = 0.014). CONCLUSIONS These findings indicate that activation of mitochondrial fission and quality control occur early in the onset of insulin resistance in human skeletal muscle. Targeting mitochondrial dynamics and quality control represents a promising new pharmacological approach for treating insulin resistance and type 2 diabetes. CLINICAL TRIAL REGISTRATION NCT02697201, ClinicalTrials.gov.
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A Single Bout of Premeal Resistance Exercise Improves Postprandial Glucose Metabolism in Obese Men with Prediabetes.
Bittel, AJ, Bittel, DC, Mittendorfer, B, Patterson, BW, Okunade, AL, Abumrad, NA, Reeds, DN, Cade, WT
Medicine and science in sports and exercise. 2021;53(4):694-703
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Prediabetes is a metabolic condition defined by elevated fasting (impaired fasting glucose) and/or postprandial (impaired glucose tolerance) plasma glucose. The aim of this study was to determine the effects of a single bout of resistance exercise on postprandial glucose metabolism following a mixed meal in obese, sedentary men with prediabetes. This study is a randomised, cross-over study design which enrolled ten participants. Participants were aged 39-62 years, obese, and demonstrated insulin resistance with compensatory increases in beta cell function. Results show that a single bout of resistance exercise performed 4.5 hours before a mixed meal (as opposed to an oral glucose tolerance test) reduced total postprandial glucose appearance, increased insulin sensitivity, and reduced the glycaemic response to a mixed meal. However, it did not have effect on glucose oxidation in obese men with prediabetes. Improvements in insulin sensitivity were complemented by reduced postprandial insulin concentration. Authors conclude that further investigation is needed to elucidate how resistance exercise affects exogenous (meal) vs endogenous postprandial glucose metabolism, and if additional bouts of exercise (i.e. training) produce superior outcomes for this population.
Abstract
INTRODUCTION Prediabetes is a major risk factor for type 2 diabetes and cardiovascular diseases. Although resistance exercise (RE) is recommended for individuals with prediabetes, the effects of RE on postprandial glucose metabolism in this population are poorly understood. Therefore, the purpose of this study was to elucidate how RE affects postprandial glucose kinetics, insulin sensitivity, beta cell function, and glucose oxidation during the subsequent meal in sedentary men with obesity and prediabetes. METHODS We studied 10 sedentary men with obesity (body mass index, 33 ± 3 kg·m-2) and prediabetes by using a randomized, cross-over study design. After an overnight fast, participants completed either a single bout of whole-body RE (seven exercises, 3 sets of 10-12 repetitions at 80% one-repetition maximum each) or an equivalent period of rest. Participants subsequently completed a mixed meal test in conjunction with an intravenous [6,6-2H2]glucose infusion to determine basal and postprandial glucose rate of appearance (Ra) and disappearance (Rd) from plasma, insulin sensitivity, and the insulinogenic index (a measure of beta cell function). Skeletal muscle biopsies were obtained 90 min postmeal to evaluate pyruvate-supported and maximal mitochondrial respiration. Whole-body carbohydrate oxidation was assessed using indirect calorimetry. RESULTS RE significantly reduced the postprandial rise in glucose Ra and plasma glucose concentration. Postprandial insulin sensitivity was significantly greater after RE, whereas postprandial plasma insulin concentration was significantly reduced. RE had no effect on the insulinogenic index, postprandial pyruvate respiration, or carbohydrate oxidation. CONCLUSION/INTERPRETATION A single bout of RE has beneficial effects on postprandial glucose metabolism in men with obesity and prediabetes by increasing postprandial insulin sensitivity, reducing the postprandial rise in glucose Ra, and reducing postprandial plasma insulin concentration.
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A cross-sectional study: Associations between sarcopenia and clinical characteristics of patients with type 2 diabetes.
Cui, M, Gang, X, Wang, G, Xiao, X, Li, Z, Jiang, Z, Wang, G
Medicine. 2020;99(2):e18708
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Sarcopenia is characterised by the loss of muscle mass, decrease of muscle strength and decline of physical performance and is related to reduced physical ability, impaired cardiorespiratory function, disability and death in the elderly. Type 2 diabetics are at higher risk of developing sarcopenia. The aim of this cross-sectional study was to evaluate clinical characteristics of sarcopenia in elderly type 2 diabetics in the Northeast of China. 132 participants completed the study which was based on self-reported medical and lifestyle history, and clinical evaluations including measurements of weight, height and muscle strength, imaging to establish sarcopenia and blood tests. 28.8% of participants had sarcopenia. Age, increased truncal fat mass and increased free thyroxine increased the risk of sarcopenia, whilst regular exercise, being female, taking metformin, a higher body mass index and increased trunk skeletal mass were associated with a lower risk of sarcopenia. The authors point out that limitations include the small sample size and that, as this is a cross-sectional study, cause and effect cannot be established.
Abstract
Sarcopenia is a geriatric syndrome and it impairs physical function. Patients with type 2 diabetes mellitus (T2DM) are at a higher risk of sarcopenia. The purpose of this study is to explore characteristics of general information and metabolic factors of sarcopenia in patients with T2DM in the northeast of China, and provide information for the prevention and treatment of sarcopenia in clinical practice.Patients with T2DM aged ≥65 were recruited in Changchun from March 2017 to February 2018. Questionnaires of general information, physical examination, laboratory and imaging examination were conducted. The patients were assigned into sarcopenia group and non-sarcopenia group according to the diagnostic criteria proposed by Asian working group for sarcopenia (AWGS), and the differences between 2 groups were analyzed.A total of 132 participants were included in this study, of which, 38 (28.8%) were diagnosed with sarcopenia. 94 (71.2%) were with no sarcopenia. Logistic regression analysis showed that age (OR: 1.182, 95%CI: 1.038-1.346), trunk fat mass (TFM) (OR: 1.499, 95%CI: 1.146-1.960) and free thyroxine (FT4) (OR: 1.342, 95%CI: 1.102-1.635) were independent risk factors for sarcopenia. BMI (body mass index) (OR: 0.365, 95%CI: 0.236-0.661), exercise (OR: 0.016, 95%CI: 0.001-0.169), female (OR: 0.000, 95%CI: 0.00-0.012), metformin (OR: 0.159, 95%CI: 0.026-0.967) and TSM (trunk skeletal muscle mass) (OR: 0.395, 95%CI: 0.236-0.661) were protective factors for sarcopenia.Sarcopenia in patients with T2DM is associated with increased age, increased TFM and increased FT4 level. Regular exercise, female, metformin administrations, high BMI and increased TSM are associated with lower risk of sarcopenia.
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Insulin resistance drives hepatic de novo lipogenesis in nonalcoholic fatty liver disease.
Smith, GI, Shankaran, M, Yoshino, M, Schweitzer, GG, Chondronikola, M, Beals, JW, Okunade, AL, Patterson, BW, Nyangau, E, Field, T, et al
The Journal of clinical investigation. 2020;130(3):1453-1460
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Non-alcoholic fatty liver disease (NAFLD) is a common complication of obesity and is associated with multiorgan insulin resistance, dyslipidaemia and an increased risk of diabetes and coronary heart disease. The aims of this study were to (a) determine hepatic de novo lipogenesis (DNL) [the liver’s biochemical process of synthesising fatty acids] in 3 distinct cohorts, (b) determine the relationships among hepatic DNL and intrahepatic [within the liver] triglyceride (IHTG) content, and (c) determine the effect of moderate (10%) weight loss. This study is a cross-sectional study which included a total of 67 men and women (mean age: 39 ± 1 years; 14 men and 53 women). Results highlight the importance of DNL in the pathogenesis of hepatic steatosis [build up of fats in the liver] and suggest that increases in daily 24-hour plasma glucose and insulin concentrations are major drivers of increased DNL in individuals with obesity and NAFLD. Additionally, moderate (10%) weight loss caused a marked decrease in both hepatic DNL and IHTG content. Authors conclude that increases in circulating glucose and insulin promote hepatic DNL in individuals with NAFLD. Whereas an improvement in insulin sensitivity and a decrease in hepatic DNL, are potentially important contributors to the decline in IHTG content associated with moderate weight loss.
Abstract
BACKGROUNDAn increase in intrahepatic triglyceride (IHTG) is the hallmark feature of nonalcoholic fatty liver disease (NAFLD) and is decreased by weight loss. Hepatic de novo lipogenesis (DNL) contributes to steatosis in individuals with NAFLD. The physiological factors that stimulate hepatic DNL and the effect of weight loss on hepatic DNL are not clear.METHODSHepatic DNL, 24-hour integrated plasma insulin and glucose concentrations, and both liver and whole-body insulin sensitivity were determined in individuals who were lean (n = 14), obese with normal IHTG content (n = 26), or obese with NAFLD (n = 27). Hepatic DNL was assessed using the deuterated water method corrected for the potential confounding contribution of adipose tissue DNL. Liver and whole-body insulin sensitivity was assessed using the hyperinsulinemic-euglycemic clamp procedure in conjunction with glucose tracer infusion. Six subjects in the obese-NAFLD group were also evaluated before and after a diet-induced weight loss of 10%.RESULTSThe contribution of hepatic DNL to IHTG-palmitate was 11%, 19%, and 38% in the lean, obese, and obese-NAFLD groups, respectively. Hepatic DNL was inversely correlated with hepatic and whole-body insulin sensitivity, but directly correlated with 24-hour plasma glucose and insulin concentrations. Weight loss decreased IHTG content, in conjunction with a decrease in hepatic DNL and 24-hour plasma glucose and insulin concentrations.CONCLUSIONSThese data suggest hepatic DNL is an important regulator of IHTG content and that increases in circulating glucose and insulin stimulate hepatic DNL in individuals with NAFLD. Weight loss decreased IHTG content, at least in part, by decreasing hepatic DNL.TRIAL REGISTRATIONClinicalTrials.gov NCT02706262.FUNDINGThis study was supported by NIH grants DK56341 (Nutrition Obesity Research Center), DK20579 (Diabetes Research Center), DK52574 (Digestive Disease Research Center), and RR024992 (Clinical and Translational Science Award), and by grants from the Academy of Nutrition and Dietetics Foundation, the College of Natural Resources of UCB, and the Pershing Square Foundation.
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Brown Adipose Crosstalk in Tissue Plasticity and Human Metabolism.
Scheele, C, Wolfrum, C
Endocrine reviews. 2020;41(1)
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Brown adipose tissue (BAT) is an important contributor to the regulation of metabolism via cellular communication with organs such as liver, muscle, gut and central nervous system. BAT is important for heat generation and is at high levels in human infants. Levels of activation of BAT decline as we age and it has been shown that the amount of BAT is smaller and its activity reduced in those with obesity and type 2 diabetes. To date, there is no answer to efficiently restore functional BAT in aging and obese subjects. This review looks at experiments done on the factors secreted from active BAT (batokines). The review aims to provide a structure for the processes and cell types involved in BAT and the recent findings of BAT whole-body communication are discussed. Altogether, these findings demonstrate that BAT has an adaptive capacity. Studying batokines, offers an alternative approach to identify novel drug targets for metabolic regulation.
Abstract
Infants rely on brown adipose tissue (BAT) as a primary source of thermogenesis. In some adult humans, residuals of brown adipose tissue are adjacent to the central nervous system and acute activation increases metabolic rate. Brown adipose tissue (BAT) recruitment occurs during cold acclimation and includes secretion of factors, known as batokines, which target several different cell types within BAT, and promote adipogenesis, angiogenesis, immune cell interactions, and neurite outgrowth. All these processes seem to act in concert to promote an adapted BAT. Recent studies have also provided exciting data on whole body metabolic regulation with a broad spectrum of mechanisms involving BAT crosstalk with liver, skeletal muscle, and gut as well as the central nervous system. These widespread interactions might reflect the property of BAT of switching between an active thermogenic state where energy is highly consumed and drained from the circulation, and the passive thermoneutral state, where energy consumption is turned off. (Endocrine Reviews 41: XXX - XXX, 2020).
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Regular Supplementation With Resveratrol Improves Bone Mineral Density in Postmenopausal Women: A Randomized, Placebo-Controlled Trial.
Wong, RH, Thaung Zaw, JJ, Xian, CJ, Howe, PR
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2020;35(11):2121-2131
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Osteoporosis is a silent disease characterized by progressive deterioration of bone tissue, gradually compromising bone strength. Phytoestrogens such as soy isoflavones and resveratrol have structural similarity to oestrogen and can bind to oestrogen receptors to exert a multitude of benefits for which oestrogen is responsible, and they have attracted interest as potential bone health therapies in oestrogen-deficient postmenopausal women. The aim of this study was to investigate whether (a) resveratrol has beneficial effects on bone mineral density (BMD) in postmenopausal women, and (b) there is any potential interaction between resveratrol and vitamin D and/or calcium supplements. The Resveratrol for Healthy Aging in Women trial is a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention. This study focuses on outcomes for bone health and biomarkers of bone metabolism. Results show that low-dose resveratrol supplementation significantly improved BMD of the lumbar spine and femoral neck. It also reduced the bone resorption marker, CTX, in postmenopausal women. The magnitude of benefit was greater for women with suboptimal bone metabolism. Authors conclude that improvement of the microcirculation may be an additional area to target in preventing postmenopausal osteoporosis.
Abstract
Resveratrol, a naturally occurring polyphenol in red grapes and berries, can act as a phytoestrogen. It has been shown to improve both systemic and cerebral circulatory functions, possibly through activation of endothelial estrogen receptors. in vitro and in vivo studies in rodent models also indicate a bone-protective role for resveratrol, particularly in ovariectomized rat models that mimic postmenopausal osteoporosis caused by estrogen deficiency. Hypothesizing a circulatory benefit of resveratrol in bone tissue, we investigated whether resveratrol supplementation could improve bone health in postmenopausal women. The Resveratrol for Healthy Aging in Women (RESHAW) trial was a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention conducted to evaluate the effects of resveratrol (75 mg twice daily) on cognition, cerebrovascular function, bone health, cardiometabolic markers, and well-being in postmenopausal women. After 12 months of supplementation with resveratrol versus placebo, there were positive effects on bone density in the lumbar spine (+0.016 ± 0.003 g/cm2 ) and neck of femur (+0.005 ± 0.002 g/cm2 ), which were accompanied by a 7.24% reduction in C-terminal telopeptide type-1 collagen levels, a bone resorption marker, compared with placebo. The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070 ± 0.018) and a reduction in the 10-year probability of major and hip fracture risk. The magnitude of improvement was higher in women with poor bone health biomarker status. Importantly, the improvement in femoral neck T-score with resveratrol correlated with improvement in perfusion. Our subanalysis also revealed that the bone-protective benefit of resveratrol was greater in participants who supplemented with vitamin D plus calcium. Regular supplementation with 75 mg of resveratrol twice daily has the potential to slow bone loss in the lumbar spine and femoral neck, common fracture sites in postmenopausal women without overt osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.
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Adherence to the Mediterranean Diet and Its Association with Body Composition and Physical Fitness in Spanish University Students.
Cobo-Cuenca, AI, Garrido-Miguel, M, Soriano-Cano, A, Ferri-Morales, A, Martínez-Vizcaíno, V, Martín-Espinosa, NM
Nutrients. 2019;11(11)
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The Mediterranean diet (MD) represents a dietary pattern that incorporates healthy traditional eating habits which includes high consumption of vegetables, fruit, legumes, nuts, beans, whole grains, fish, and unsaturated fats, and low consumption of red meat and dairy products. The Mediterranean Diet Adherence Screener (MEDAS-14 items) is a valid instrument for the estimation of adherence to the MD. The objectives of this study were to: 1. Estimate the prevalence of the adherence to the MD 2. Assess the association of adherence to the MD with physical fitness and body composition 3. Know the ability of each MEDAS item in the same sample to predict MD adherence. This study is a cross-sectional observational study which was performed with 310 first-year Spanish university students, aged between 18 and 30 years. Results indicate low prevalence of good adherence to the MD; and the participants with good adherence had high protein and low-fat intake compared to those with medium to low adherence. Furthermore, higher levels of physical fitness were also noticed amongst participants with good adherence to the MD. Twelve of the 14 items of the MEDAS score were associated with a high adherence to the MD. Authors conclude that MD adherence benefits both cardiorespiratory and muscular fitness amongst young adults.
Abstract
The aims of this study were to assess the association of adherence to the Mediterranean diet (MD) with physical fitness and body composition in Spanish university students and to determine the ability to predict the MD adherence of each Mediterranean Diet Adherence Screener (MEDAS) item. A cross-sectional study was performed involving 310 first-year university students. Adherence to the MD was evaluated with MEDAS-14 items. Anthropometric variables, body composition, and physical fitness were assessed. Muscle strength was determined based on handgrip strength and the standing long jump test. Cardiorespiratory fitness (CRF) was measured using the Course-Navette test. Only 24% of the university students had good adherence to the MD. The ANCOVA models showed a significant difference between participants with high adherence to the MD and those with medium and low adherence in CRF (p = 0.017) and dynamometry (p = 0.005). Logistic binary regression showed that consuming >2 vegetables/day (OR = 20.1; CI: 10.1-30.1; p < 0.001), using olive oil (OR = 10.6; CI: 1.4-19.8; p = 0.021), consuming <3 commercial sweets/week (OR = 10.1; IC: 5.1-19.7; p < 0.001), and consuming ≥3 fruits/day (OR = 8.8; CI: 4.9-15.7; p < 0.001) were the items most associated with high adherence to the MD. In conclusion, a high level of adherence to the MD is associated with high-level muscular fitness and CRF in Spanish university students.
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App-technology to improve lifestyle behaviors among working adults - the Health Integrator study, a randomized controlled trial.
Bonn, SE, Löf, M, Östenson, CG, Trolle Lagerros, Y
BMC public health. 2019;19(1):273
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Lifestyle is the single most important factor to improve health and decrease premature death. Digital solutions for implementing lifestyle change and tracking different types of health data are becoming popular preventative initiatives. The main aim of this study was to evaluate whether a digital platform (The Health Integrator) accessible via a smartphone-app offering lifestyle intervention, with and without additional health coach guidance, can be used to make lifestyle changes and improve health related quality of life in gainfully employed persons. The Health Integrator intervention study is a three-arm parallel randomized controlled trial. Participants were randomized to 1 of 3 groups: 1) intervention using Health Integrator and a monthly telephone session with the health coach during the 3 months of follow-up or 2) intervention using Health Integrator without extra health coach sessions or 3) control group which is not given any lifestyle advise during the intervention period. The study is still ongoing. However, mobile Health has been suggested as one way to take global action as it has the potential to make treatment and prevention widely accessible at a fraction of the current cost. In fact, Health Integrator was developed on the basis of previous research. Current literature shows that multi-component interventions including for example face-to-face counselling or provision of physical activity equipment in addition to an app, were more successful than a stand-alone app intervention.
Abstract
BACKGROUND Mobile health, mHealth is recognized as a strategy to improve lifestyle behaviors. Research targeting specific lifestyle behaviors has shown that interventions using smartphones can be effective. However, few studies have evaluated solutions with multicomponent interventions, tailoring the intervention to the specific needs of the participant using a combination of mHealth and conventional treatment. To accomplish this, we developed Health Integrator, an mHealth platform with services and offers in the areas of diet, physical activity, sleeping habits, stress, alcohol and tobacco use. In the system, the user selects an area of intervention together with a health coach and set weekly goals. This study protocol presents the design and methodology of the Health Integrator Study, a randomized controlled trial to promote improved lifestyle behaviors. METHODS A three-arm parallel randomized controlled trial (1:1:1) is conducted in the Stockholm County, Sweden. In total, 209 employees at a four different companies representing both white and blue collar workers, have been recruited. Participants are randomized to either a control group or to one of two intervention groups receiving a 3-month lifestyle behavior change program including either 1) use of Health Integrator and monthly health coaching sessions or 2) only Health Integrator. At baseline and follow-up after 3- and 6-months, all participants answer questionnaires assessing lifestyle behaviors and quality of life. At baseline and the 3-month follow-up (end of intervention period), weight, height, waist circumference and blood pressure are measured, and all participants wear an Actigraph accelerometer for 7 days to assess physical activity. Blood lipid profile and HbA1c are measured among all participants at baseline. If baseline measures fall outside the normal range, a second measurement is done after 3 months. DISCUSSION The Health Integrator Intervention Study will evaluate if a personalized intervention combining mHealth and conventional programs for lifestyle change, with or without additional health coach sessions, can improve lifestyle behaviors and quality of life. Based on the results from this trial, Health Integrator can easily be implemented within a broad public. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03579342 . Retrospectively registered, first submitted May 8, 2018.
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A Randomized Placebo-Controlled Trial of Low- Versus Moderate-Dose Vitamin D3 Supplementation on Bone Mineral Density in Postmenopausal Women With HIV.
Yin, MT, RoyChoudhury, A, Bucovsky, M, Colon, I, Ferris, DC, Olender, S, Agarwal, S, Sharma, A, Zeana, C, Zingman, B, et al
Journal of acquired immune deficiency syndromes (1999). 2019;80(3):342-349
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Prevalence of fracture is 2 to 3-fold higher in women with HIV over age 50 than in the general population. The aim of this study was to compare the effects of two doses of vitamin D3 repletion (3000 IU Vs 1000 IU) on bone turnover and change in bone mass and microarchitecture in postmenopausal women with HIV. The study is a randomised placebo-controlled study which recruited women with HIV aged between 40 and 70 years. The participants were randomised to 3000 vs 1000 IU vitamin D3 daily together with 500mg calcium carbonate twice daily. Results indicate that moderate dose vitamin D3 (3000 IU) supplementation in minority postmenopausal women with HIV on established antiretroviral therapy (treatment for HIV) did not appear to have a greater impact on bone mineral density or bone turnover than low dose vitamin D3 supplementation (1000 IU). Authors conclude that further studies are required to determine whether vitamin D3 supplementation is beneficial in this patient population, and if so, what dose provides the maximum benefit in terms of musculoskeletal health in persons aging with HIV.
Abstract
BACKGROUND Prevalence of osteoporosis and fracture is increased among older people with HIV. We compared the effects of low (1000 IU) vs moderate (3000 IU) vitamin D3 (VitD) supplementation on areal bone mineral density (aBMD) and volumetric bone mineral density (vBMD) in African American and Hispanic postmenopausal women with HIV on antiretroviral therapy. METHODS We performed a 12-month prospective, randomized, double-blind, placebo-controlled study with primary outcomes of change in aBMD by dual-energy X-ray absorptiometry (DXA) and secondary outcomes of change in vBMD by quantitative computed tomography and bone turnover markers. An intent-to-treat analysis was performed on 85 randomized subjects (43 low and 42 moderate) for primary DXA outcomes, and complete case analysis was performed for secondary outcomes. RESULTS Mean age was 56 ± 5 years, median CD4 count was 722 cells/mm, and 74% had HIV RNA ≤ 50 copies/mL. Serum 25-OHD was higher in the moderate than low VitD group at 6 months (33.1 ± 10.3 vs 27.8 ± 8.1 ng/mL, P = 0.03) and 12 months, but parathyroid hormone levels remained similar. Percent change in aBMD, vBMD, and bone turnover markers did not differ between low and moderate VitD groups before or after adjustment for baseline aBMD. CONCLUSIONS VitD supplementation at 3000 IU daily increased mean total 25-OHD levels in postmenopausal women with HIV, but we did not find evidence of an effect on BMD beyond those observed with 1000 IU daily. Future studies are necessary to determine whether VitD supplementation is beneficial in this patient population, and if so, what dose is optimal for skeletal health.