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Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial.
Rein, M, Ben-Yacov, O, Godneva, A, Shilo, S, Zmora, N, Kolobkov, D, Cohen-Dolev, N, Wolf, BC, Kosower, N, Lotan-Pompan, M, et al
BMC medicine. 2022;20(1):56
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Type 2 diabetes mellitus (T2DM) affects around 10% of the global population. The primary goal in its management is to improve glycemic control. Modifying the diet can help, but many patients fail to achieve improvements with diet alone. The aim of the randomized dietary intervention pilot trial is to evaluate the effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in 23 adults with newly diagnosed T2DM, as compared to the commonly recommended Mediterranean-style (MED) diet. The PPT diet led to significant lower levels of continuous-glucose-monitoring (CGM)-based measures as compared to the MED diet. In the additional 6-months intervention, metabolic parameters were further improved and 61% of the participants exhibited diabetes remission. Improvements in clinical outcomes were also accompanied by changes in the gut microbiome. These findings may be useful for the design of larger studies in the future that may have implications for dietary advice in clinical practice.
Abstract
BACKGROUND Dietary modifications are crucial for managing newly diagnosed type 2 diabetes mellitus (T2DM) and preventing its health complications, but many patients fail to achieve clinical goals with diet alone. We sought to evaluate the clinical effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in individuals with newly diagnosed T2DM as compared to the commonly recommended Mediterranean-style (MED) diet. METHODS We enrolled 23 adults with newly diagnosed T2DM (aged 53.5 ± 8.9 years, 48% males) for a randomized crossover trial of two 2-week-long dietary interventions. Participants were blinded to their assignment to one of the two sequence groups: either PPT-MED or MED-PPT diets. The PPT diet relies on a machine learning algorithm that integrates clinical and microbiome features to predict personal postprandial glucose responses (PPGR). We further evaluated the long-term effects of PPT diet on glycemic control and metabolic health by an additional 6-month PPT intervention (n = 16). Participants were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using a smartphone application. RESULTS In the crossover intervention, the PPT diet lead to significant lower levels of CGM-based measures as compared to the MED diet, including average PPGR (mean difference between diets, - 19.8 ± 16.3 mg/dl × h, p < 0.001), mean glucose (mean difference between diets, - 7.8 ± 5.5 mg/dl, p < 0.001), and daily time of glucose levels > 140 mg/dl (mean difference between diets, - 2.42 ± 1.7 h/day, p < 0.001). Blood fructosamine also decreased significantly more during PPT compared to MED intervention (mean change difference between diets, - 16.4 ± 37 μmol/dl, p < 0.0001). At the end of 6 months, the PPT intervention leads to significant improvements in multiple metabolic health parameters, among them HbA1c (mean ± SD, - 0.39 ± 0.48%, p < 0.001), fasting glucose (- 16.4 ± 24.2 mg/dl, p = 0.02) and triglycerides (- 49 ± 46 mg/dl, p < 0.001). Importantly, 61% of the participants exhibited diabetes remission, as measured by HbA1c < 6.5%. Finally, some clinical improvements were significantly associated with gut microbiome changes per person. CONCLUSION In this crossover trial in subjects with newly diagnosed T2DM, a PPT diet improved CGM-based glycemic measures significantly more than a Mediterranean-style MED diet. Additional 6-month PPT intervention further improved glycemic control and metabolic health parameters, supporting the clinical efficacy of this approach. TRIAL REGISTRATION ClinicalTrials.gov number, NCT01892956.
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Effects of fructose restriction on liver steatosis (FRUITLESS); a double-blind randomized controlled trial.
Simons, N, Veeraiah, P, Simons, PIHG, Schaper, NC, Kooi, ME, Schrauwen-Hinderling, VB, Feskens, EJM, van der Ploeg, EMCL, Van den Eynde, MDG, Schalkwijk, CG, et al
The American journal of clinical nutrition. 2021;113(2):391-400
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The use of fructose in the food industry may have contributed to the increase in non-alcoholic fatty liver disease (NAFLD) in the general population. Consequently, obesity and associated comorbidities like type 2 diabetes, dyslipidaemia, NAFLD, and cardiovascular disease have increased. Although glucose and fructose are both sugars, they are metabolised differently by the body. The overfeeding of fructose may contribute to steatosis or accumulation of fat in the liver than glucose. The aim of this randomised, double-blind trial was to measure intrahepatic lipid content in 44 overweight subjects with high fatty liver index following fructose restriction for six weeks. In this study, fructose restriction resulted in a small but significant reduction in intrahepatic lipid content with a small effect size of 0.7% point. Fructose restriction did not seem to affect glucose tolerance, serum lipid concentration or HOMA-IR, variables related to intrahepatic lipid content. As a supplement, fructose may have a different metabolic profile than when taken as a food component. The study found no effect on glucose tolerance or serum lipid levels. The results of this study may help healthcare professionals to comprehend the role of fructose in steatosis and NAFLD.
Abstract
BACKGROUND There is an ongoing debate on whether fructose plays a role in the development of nonalcoholic fatty liver disease. OBJECTIVES The aim of this study was to investigate the effects of fructose restriction on intrahepatic lipid (IHL) content in a double-blind randomized controlled trial using an isocaloric comparator. METHODS Between March 2017 and October 2019, 44 adult overweight individuals with a fatty liver index ≥ 60 consumed a 6-wk fructose-restricted diet (<7.5 g/meal and <10 g/d) and were randomly assigned to supplementation with sachets of glucose (= intervention group) or fructose (= control group) 3 times daily. Participants and assessors were blinded to the allocation. IHL content, assessed by proton magnetic resonance spectroscopy, was the primary outcome and glucose tolerance and serum lipids were the secondary outcomes. All measurements were conducted in Maastricht University Medical Center. RESULTS Thirty-seven participants completed the study protocol. After 6 wk of fructose restriction, dietary fructose intake and urinary fructose excretion were significantly lower in the intervention group (difference: -57.0 g/d; 95% CI: -77.9, -39.5 g/d; and -38.8 μmol/d; 95% CI: -91.2, -10.7 μmol/d, respectively). Although IHL content decreased in both the intervention and control groups (P < 0.001 and P = 0.003, respectively), the change in IHL content was more pronounced in the intervention group (difference: -0.7% point, 95% CI: -2.0, -0.03% point). The changes in glucose tolerance and serum lipids were not significantly different between groups. CONCLUSIONS Six weeks of fructose restriction per se led to a small, but statistically significant, decrease in IHL content in comparison with an isocaloric control group.This trial was registered at clinicaltrials.gov as NCT03067428.
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Acute responses of hepatic fat content to consuming fat, glucose and fructose alone and in combination in non-obese non-diabetic individuals with non-alcoholic fatty liver disease.
Kovar, J, Dusilova, T, Sedivy, P, Bruha, R, Gottfriedova, H, Pavlikova, P, Pitha, J, Smid, V, Drobny, M, Dezortova, M, et al
Journal of physiology and pharmacology : an official journal of the Polish Physiological Society. 2021;72(1)
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Non-alcoholic fatty liver disease (NAFLD) is often associated with obesity or conditions related to obesity, such as type 2 diabetes. Steatosis is one of the four stages of NAFLD, where there is a small layer of fat build-up on the liver. Currently, one in three people in the UK has simple fatty liver or steatosis. A fascinating aspect of this study is exploring the long-term cumulative effects of daily fat intake when consumed with glucose or fructose and in the pathogenesis of steatosis. In this randomised controlled study, the researchers examined the immediate impact of high-fat loads on hepatic fat content (HFC) when administered with glucose or fructose in eight healthy overweight males with NFALD. The experiments lasted only eight hours. HFC was only transiently elevated by co-administration of glucose and high-fat loading. However, fructose co-administration with multiple high-fat loads promoted HFC. Small sample size and short duration are the limitations of this study. Long-term robust studies are needed to confirm the findings. Yet, healthcare professionals can use this study to distinguish between the immediate effects of fructose or glucose when combined with multiple doses of high fat on HFC in healthy and NAFLD subjects.
Abstract
We have recently demonstrated that a high-fat load can induce immediate increase in hepatic fat content (HFC) and that such an effect can be modified differently by co-administration of fructose or glucose in healthy subjects. Therefore, we addressed the question how consumption of these nutrients affects changes in HFC in subjects with non-alcoholic fatty liver disease (NAFLD). Eight male non-obese non-diabetic patients with NAFLD underwent 6 experiments each lasting 8 hours: 1. fasting, 2. high-fat load (150 g of fat (dairy cream) at time 0), 3. glucose (three doses of 50 g at 0, 2, and 4 hours), 4. high-fat load with three doses of 50 g of glucose, 5. fructose (three doses of 50 g at 0, 2, and 4 hours), 6. high-fat load with three doses of 50 g of fructose. HFC was measured using magnetic resonance spectroscopy prior to meal administration and 3 and 6 hours later. Plasma triglycerides, non-esterified fatty acids, glucose and insulin were monitored throughout each experiment. HFC increased by 10.4 ± 6.9% six hours after a high-fat load and by 15.2 ± 12.5% after high-fat load with fructose. When co-administering glucose with fat, HFC rose only transiently to return to baseline at 6 hours. Importantly, NAFLD subjects accumulated almost five times more fat in their livers than healthy subjects with normal HFC. Consumption of a high-fat load results in fat accumulation in the liver of NAFLD patients. Fat accumulation after a fat load is diminished by glucose but not fructose co-administration.
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Metabolic, hormonal and performance effects of isomaltulose ingestion before prolonged aerobic exercise: a double-blind, randomised, cross-over trial.
Notbohm, HL, Feuerbacher, JF, Papendorf, F, Friese, N, Jacobs, MW, Predel, HG, Zacher, J, Bloch, W, Schumann, M
Journal of the International Society of Sports Nutrition. 2021;18(1):38
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Isomaltulose is a low-glycaemic index carbohydrate that lowers insulin and glucose levels postprandially. The benefits of taking Isomaltulose in an exercise setting are not well studied. This double-blinded, randomised, crossover study evaluated the effects of Isomaltulose intake on metabolic responses, hormonal responses, exercise performance and gastrointestinal disturbances in runners. Twenty-one male recreational endurance runners took part in four separate experimental sessions to compare Isomaltulose to maltodextrin and glucose. Fat and carbohydrate oxidation rates were not different among groups. This might be because the lower dose of Isomaltulose (50g) was used in this trial. Compared to glucose and maltodextrin, isomaltulose lowered metabolic and hormonal responses to exercise. In the study, Isomaltulose, glucose, and maltodextrin did not differ in exercise performance or gastrointestinal disturbances. A higher dose may be needed in order to demonstrate exercise performance, but caution should be exercised since a higher dose may cause gastrointestinal upset. A robust investigation of Isomalulose dose and its effects on glucose, insulin, and glucose-dependent insulinotropic polypeptides is required to determine if exercise leads to hypoglycaemia in the clinical population. Healthcare practitioners can use the findings of this study to understand the advantageous effects of 50g Isomaltulose in regulating glucose, insulin and glucose-dependent insulinotropic polypeptide during aerobic exercise.
Abstract
BACKGROUND Isomaltulose has been discussed as a low glycaemic carbohydrate but evidence concerning performance benefits and physiological responses has produced varying results. Therefore, we primarily aimed to investigate the effects of isomaltulose ingestion compared to glucose and maltodextrin on fat and carbohydrate oxidation rates, blood glucose levels and serum hormone concentrations of insulin and glucose-dependent insulinotropic polypeptide (GIP). As secondary aims, we assessed running performance and gastrointestinal discomfort. METHODS Twenty-one male recreational endurance runners performed a 70-min constant load trial at 70% maximal running speed (Vmax), followed by a time to exhaustion (TTE) test at 85% Vmax after ingesting either 50 g isomaltulose, maltodextrin or glucose. Fat and carbohydrate oxidation rates were calculated from spiroergometric data. Venous blood samples for measurement of GIP and insulin were drawn before, after the constant load trial and after the TTE. Capillary blood samples for glucose concentrations and subjective feeling of gastrointestinal discomfort were collected every 10 min during the constant load trial. RESULTS No between-condition differences were observed in the area under the curve analysis of fat (p = 0.576) and carbohydrate oxidation rates (p = 0.887). Isomaltulose ingestion led to lower baseline postprandial concentrations of blood glucose compared to maltodextrin (percent change [95% confidence interval], - 16.7% [- 21.8,-11.6], p < 0.001) and glucose (- 11.5% [- 17.3,-5.7], p = 0.001). Similarly, insulin and GIP concentrations were also lower following isomaltulose ingestion compared to maltodextrin (- 40.3% [- 50.5,-30.0], p = 0.001 and - 69.1% [- 74.3,-63.8], p < 0.001, respectively) and glucose (- 32.6% [- 43.9,-21.2], p = 0.012 and - 55.8% [- 70.7,-40.9], p < 0.001, respectively). Furthermore, glucose fluctuation was lower after isomaltulose ingestion compared to maltodextrin (- 26.0% [- 34.2,-17.8], p < 0.001) and glucose (- 17.4% [- 29.1,-5.6], p < 0.001). However, during and after exercise, no between-condition differences for glucose (p = 0.872), insulin (p = 0.503) and GIP (p = 0.244) were observed. No between-condition differences were found for TTE (p = 0.876) or gastrointestinal discomfort (p = 0.119). CONCLUSION Isomaltulose ingestion led to lower baseline postprandial concentrations of glucose, insulin and GIP compared to maltodextrin and glucose. Consequently, blood glucose fluctuations were lower during treadmill running after isomaltulose ingestion, while no between-condition differences were observed for CHO and fat oxidation rates, treadmill running performance and gastrointestinal discomfort. Further research is required to provide specific guidelines on supplementing isomaltulose in performance and health settings.
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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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Dietary Glycemic Index and Load and the Risk of Type 2 Diabetes: Assessment of Causal Relations.
Livesey, G, Taylor, R, Livesey, HF, Buyken, AE, Jenkins, DJA, Augustin, LSA, Sievenpiper, JL, Barclay, AW, Liu, S, Wolever, TMS, et al
Nutrients. 2019;11(6)
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It is generally accepted that certain diet and lifestyle choices contribute to a person’s risk of developing type 2 diabetes (T2D). In this meta-analysis, researchers set out to review previous studies and assess whether there is any evidence that the amount and type of carbohydrate (measured by Glycaemic Index (GI) and Glycaemic Load (GL)) in a person’s diet has a direct influence on their risk of developing T2D. The authors concluded with a high level of confidence that eating high GI and GL foods can lead to a higher risk of developing T2D. They suggest that nutrition advice that favours low GI and GL foods could produce significant cost savings for public healthcare.
Abstract
While dietary factors are important modifiable risk factors for type 2 diabetes (T2D), the causal role of carbohydrate quality in nutrition remains controversial. Dietary glycemic index (GI) and glycemic load (GL) have been examined in relation to the risk of T2D in multiple prospective cohort studies. Previous meta-analyses indicate significant relations but consideration of causality has been minimal. Here, the results of our recent meta-analyses of prospective cohort studies of 4 to 26-y follow-up are interpreted in the context of the nine Bradford-Hill criteria for causality, that is: (1) Strength of Association, (2) Consistency, (3) Specificity, (4) Temporality, (5) Biological Gradient, (6) Plausibility, (7) Experimental evidence, (8) Analogy, and (9) Coherence. These criteria necessitated referral to a body of literature wider than prospective cohort studies alone, especially in criteria 6 to 9. In this analysis, all nine of the Hill's criteria were met for GI and GL indicating that we can be confident of a role for GI and GL as causal factors contributing to incident T2D. In addition, neither dietary fiber nor cereal fiber nor wholegrain were found to be reliable or effective surrogate measures of GI or GL. Finally, our cost-benefit analysis suggests food and nutrition advice favors lower GI or GL and would produce significant potential cost savings in national healthcare budgets. The high confidence in causal associations for incident T2D is sufficient to consider inclusion of GI and GL in food and nutrient-based recommendations.
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Sugar-Sweetened Beverage Consumption in Relation to Obesity and Metabolic Syndrome among Korean Adults: A Cross-Sectional Study from the 2012⁻2016 Korean National Health and Nutrition Examination Survey (KNHANES).
Shin, S, Kim, SA, Ha, J, Lim, K
Nutrients. 2018;10(10)
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Obesity and Metabolic Syndrome (MetS) in Korea has increased significantly in the last decade and dietary factors, including the consumption of sugar sweetened drinks, is considered one of the key drivers. Soft drinks, soda coffee, fruit juices, sports drinks and sweetened rice drinks are popular beverages in Asia. Consumption of these is a major source of sugar intake for the Korean population. This study analysed data from over 12,112 participants of the Korean National Health and Nutrition Examination Survey (KNHANES) to see if the consumption of sugar sweetened beverages was causally linked to obesity and MetS. Food questionnaires were used in the original study to assess which foods and drinks the participants consumed during a 1-year period. Within the study group the number of participants with obesity was 34.9% and MetS was 26.7% respectively. They found that the participants who regularly consumed >4 sugar sweetened beverages per week consumed more calories on average than those who did not drink these beverages. In men, it was linked to higher blood pressure and blood glucose levels whilst in women it linked to a higher body mass index (BMI), increased waist circumference, and elevated cholesterol. Overall drinking 1 sugar sweetened beverage per day increased the risks of obesity in women by 59% and MetS by 61% whilst in men it increased the prevalence of obesity by 41% and MetS by 7%. Therefore drinking sugar sweetened beverages increases the risk of both obesity and MetS.
Abstract
It is well known that the consumption of sugar-sweetened beverages (SSBs) increases the risk of developing obesity and metabolic syndrome (MetS). However, there are not many studies investigating the link between SSBs and increased incidences of diseases in the Asian population, and in particular, in Korea. We explored the association of SSB consumption with the risk of developing obesity and MetS among Korean adults (12,112 participants from the 2012⁻2016 Korean National Health and Nutrition Examination Survey). We calculated the total SSB consumption frequency by counting each beverage item, including soda beverages, fruit juices, and sweetened rice drinks. Obesity was defined as a body mass index ≥25 kg/m², and MetS was defined using the National Cholesterol Education Program, Adult Treatment Panel III. A survey logistic regression analyses was conducted to examine the association of SSB consumption with obesity and MetS, adjusting for related confounders such as age, energy intake, household income, education, alcohol drinking, smoking status, and physical activity. The SSB consumption was positively associated with an increased risk of the prevalence for obesity (Odd ratio (OR): 1.60; 95% confidence interval (CI): 1.23⁻2.09; p for trend = 0.0009) and MetS (OR: 1.61; 95% CI: 1.20⁻2.16; p for trend = 0.0003) among women. In men, SSB consumption only contributed to a higher prevalence of obesity (OR: 1.38; 95% CI: 1.11⁻1.72; p for trend = 0.0041). In conclusion, increased consumption of SSBs was closely linked with a higher prevalence of obesity and MetS in the Korean population.
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Fructose metabolism and metabolic disease.
Hannou, SA, Haslam, DE, McKeown, NM, Herman, MA
The Journal of clinical investigation. 2018;128(2):545-555
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Sugar consumption is thought to be a contributing factor in the increase in diabetes and obesity and the associated risk of cardiovascular disease worldwide. Sucrose (table sugar) and high fructose corn syrup contain almost equal amounts of fructose and glucose and are commonly added to processed foods. Whilst long-term studies are lacking, some short-term intervention studies show that fructose can impair lipid metabolism and insulin sensitivity in humans. This article reviews the biochemistry and molecular genetics of fructose metabolism as well as potential mechanisms by which excessive fructose consumption contributes to cardiometabolic disease. Fructose absorption in the human intestine is saturable, and there is a large range in capacity to absorb fructose between individuals, and unabsorbed fructose may contribute to gastrointestinal symptoms including pain and bloating. Fructose concentrations in the blood can increase 10-fold after consumption, but are rapidly cleared, mostly by the liver, where it provides substrate for metabolic processes, but may also be involved in signalling functions. Fructose may enhance glucose uptake by the liver and storage as glycogen and lipids. It may also increase production of uric acid which is implicated with gout. Excessive fructose consumption affects lipid metabolism and may contribute to fat accumulation in the liver and increase circulating triglycerides, a risk factor for heart disease. In animal models it also induces increased insulin levels. Fructose is one of the sweetest sugars which may affect appetite and overeating. It may also induce addiction-like behaviours such as binging and dependence in part by stimulating dopaminergic pathways. It also appears to induce leptin resistance which further increases food intake and obesity.
Abstract
Increased sugar consumption is increasingly considered to be a contributor to the worldwide epidemics of obesity and diabetes and their associated cardiometabolic risks. As a result of its unique metabolic properties, the fructose component of sugar may be particularly harmful. Diets high in fructose can rapidly produce all of the key features of the metabolic syndrome. Here we review the biology of fructose metabolism as well as potential mechanisms by which excessive fructose consumption may contribute to cardiometabolic disease.
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Early and long period follow-up results of low glycemic index diet for migraine prophylaxis.
Evcili, G, Utku, U, Öğün, MN, Özdemir, G
Agri : Agri (Algoloji) Dernegi'nin Yayin organidir = The journal of the Turkish Society of Algology. 2018;30(1):8-11
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Environmental factors such as diet and lifestyle are known to play a role in migraine. Particular foods can act as direct triggers for individuals. Also, how the individual’s diet affects their blood sugar levels may be key to the frequency and severity of their attacks. Foods that are said to have low glycaemic index (GI), i.e. they are thought to raise blood sugar levels more slowly, may help with the management of migraine. In this randomised control trial, migraine patients were randomly allocated to either a low GI diet group or a medication group. Both groups were given tips for lifestyle changes and the diet group was also advised to eat a low GI diet and avoid high GI foods, while the medication group participants kept using their preventive medication. The frequency and severity of migraine attacks was assessed before the start of the study and at 1 month and 3 months after starting the low GI diet. At 3 months, the frequency and severity of attacks reduced significantly in both groups and the low GI diet was noted to be as effective as the drug treatment. The authors conclude that a low GI diet can be an effective and reliable method to reduce migraine attacks.
Abstract
OBJECTIVES The role of dietary restriction in the management of patients with migraine is still a controversial topic in the headache field. The aim of this study was to evaluate the efficacy of dietary restriction on migraine attacks. METHODS Patients diagnosed with migraine without aura according to the International Classification of Headaches were enrolled. Our study included 350 migraine patients evaluated at the neurology headache outpatient clinic. They were randomly divided into two groups: diet group as the study group and medication group as the control group. We told migraine patients to make lifestyle changes, especially those with low glycemic index in the diet group. On the other hand, propranolol, amitriptyline, flunarizine, and topiramate were used for the prophylaxis in the medication group. The frequency and severity of attacks [using the visual analog scale (VAS)] were recorded before starting dietary restriction and 1 and 3 months after the dietary restriction. RESULTS There were 350 participants in this study. After 3 months, a total of 147 patients (male/female: 17/130, mean age: 34.7±5.9) were evaluated in the diet group. The control group consisted of 147 age- and sex-matched, randomly selected patients with migraine without aura. In the first month after dietary restriction, monthly attack frequency significantly decreased in both groups but not the VAS score. The mean scores of VAS significantly decreased later in the diet group compared with those in the medication group (after 3 months). CONCLUSION The results of the study revealed that low glycemic index diet intake can be an effective and reliable method to reduce migraine attacks.
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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.