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Lipid Intake and Breast Cancer Risk: Is There a Link? A New Focus and Meta-Analysis.
Lodi, M, Kiehl, A, Qu, FL, Gabriele, V, Tomasetto, C, Mathelin, C
European journal of breast health. 2022;18(2):108-126
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Incidence of breast cancer is the leading cause of cancer-related mortality, accounting for 15.5% of all cancer-related deaths. However, there is a lack of complete understanding of the effects of different types of dietary lipids on breast cancer development, such as saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), dietary cholesterol, polyunsaturated fatty acids (PUFA), and unsaturated trans fatty acids (TFA). An evaluation of the effect of lipid consumption on breast cancer and the impact it has on menopausal status was conducted in this meta-analysis, which included forty-four studies. Increased saturated fatty acid intake was associated with an increased risk of breast cancer in postmenopausal women. However, breast cancer risk was not associated with increased consumption of total fat, SFA, MUFA, PUFA, and cholesterol in premenopausal women. The effects of estrogen and the release of proinflammatory cytokines by adipocytes should be evaluated, as well as other pathways that contribute to the development of breast cancer. There is a need for further robust studies to evaluate the effects of different types of lipid consumption on breast cancer. Although the association between SFA and breast cancer is weak, healthcare professionals can use this study's findings to better understand the detrimental effect of SFA, despite the fact that there is a great deal of heterogeneity in the current analysis.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The authors found no association between total fat, saturated fatty-acids, mono and poly-unsaturated fatty acids and cholesterol intake and breast cancer incidence in the general population and in pre-menopausal women.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
- Among lifestyle-related breast cancer risk factors, the role of diet in breast cancer remains uncertain.
- The authors highlight a weak association between high SFA consumption and breast cancer risk in post-menopausal women.
- The authors found no association between total fat, saturated fatty-acids, mono and poly-unsaturated fatty acids and cholesterol intake and breast cancer incidence in the general population and in pre-menopausal women.
Objectives
- To determine if there is an association between total lipid intake, saturated fatty acid (SFA), Poly- and Mono-Unsaturated Fatty Acid (PUFA and MUFA) and cholesterol intake and breast cancer risk.
Results
- Forty-four articles were included in the meta-analysis, consisting of 28 case-control studies and 16 cohort studies.
- In total, this meta-analysis involved 1,185,896 women, of whom 54,553 had breast cancer.
- There was no association between total fat, SFA, MUFA, PUFA and cholesterol intake and breast cancer in the general population and in pre-menopausal women.
- In postmenopausal women, high SFA consumption was associated with increased breast cancer risk in case-control studies [relative risk (RR): 1.12; confidence interval (CI) 95%: 1.03–1.21; p = 0.006 but not in cohort studies (RR: 1.01; CI 95%: 0.85–1.19; p = 0.93).
Limitations
- Studies included in the meta-analysis were carried out on populations from five continents with significant cultural and dietary diversity, and well as different types of oils used in the diet
Conclusion
- At this stage, the authors state it is not possible to establish nutritional recommendations regarding the consumption of lipids to decrease breast cancer risk.
Clinical practice applications:
- The results of this meta-analysis does not demonstrate a statistically significant link between high consumption of total lipids, PUFA, MUFA and cholesterol and the occurrence of breast cancer.
- However, the results suggest that there is an association between SFA intake and breast cancer risk in postmenopausal women, although this was only found in case-controlled studies and not cohort studies.
- While obesity is a known breast cancer risk factor after menopause, the link between the effect of diet and the effect of obesity on the breast may be through different mechanisms.
- The authors investigated if high lipid consumption acts on breast tissue by the same mechanisms as obesity, and found the association between SFA intake and breast cancer risk in postmenopausal women must be through other biological explanations.
- The authors found that while high SFA consumption may increase breast cancer risk among post-menopausal women, biological mechanisms linking SFA and breast cancerogenesis are still unknown.
- The meta-analysis found high blood cholesterol levels appear to increase the risk of breast cancer. However, the authors could not confirm that high dietary cholesterol intake is a risk factor for breast cancer. The authors postulated this may be in part due to the low proportion of cholesterol (about 30%) in the diet, while the rest comes from the degradation of lipids and carbohydrates by the liver.
Considerations for future research:
- As lipids can have different actions in the same family, studies should rather focus on specific lipid consumption
Abstract
Objective: To determine if there is an association between total lipid intake, saturated fatty acid (SFA), Poly- and Mono-Unsaturated Fatty Acid (PUFA and MUFA) and cholesterol intake and breast cancer risk. Materials and Methods: We conducted a systematic review of the literature and a meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We included all cohort and case-control studies published up to December 2020 with subgroup analysis according to menopausal status. Results: We included 44 articles for analysis. There was no association between total fat, SFA, MUFA, PUFA and cholesterol intake and breast cancer in the general population and in pre-menopausal women. In postmenopausal women, high SFA consumption was associated with increased breast cancer risk in case-control studies [relative risk (RR): 1.12; confidence interval (CI) 95%: 1.03-1.21; p = 0.006 but not in cohort studies (RR: 1.01; CI 95%: 0.85-1.19; p = 0.93). Conclusion: There was a weak association between high SFA consumption and breast cancer risk in post-menopausal women, however there was high heterogeneity for this analysis. As lipids can have different actions in the same family, studies should rather focus on specific lipid consumption.
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2.
Thrombosis and COVID-19: The Potential Role of Nutrition.
Tsoupras, A, Lordan, R, Zabetakis, I
Frontiers in nutrition. 2020;7:583080
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COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). The lungs seem to be the initial target organ of SARS-CoV-2, however it became clear that other systems including the cardiovascular and neurological systems were also involved. Literature shows that thrombotic complications are a significant risk factor for COVID-19 patients. In fact, adopting healthy dietary habits: - will prevent the onset of non-communicable diseases, which is a significant risk factor for the development of COVID-19, - may support the immune system to lessen the severity of an infection, and - may prevent the onset of severe thrombotic complications due to the presence of bioactive compounds with antiplatelet effects (for non-infected individuals, especially those with or at increased risk of underlying non-communicable diseases). Authors emphasise on the importance of establishing clinical trials to investigate potential pharmacological and nutritional mitigation strategies to prevent thrombotic complications as a result of severe COVID-19 infection.
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the coronavirus disease (COVID-19), is a contagion that has rapidly spread around the globe. COVID-19 has caused significant loss of life and disrupted global society at a level never before encountered. While the disease was predominantly characterized by respiratory symptoms initially, it became clear that other systems including the cardiovascular and neurological systems were also involved. Several thrombotic complications were reported including venous thrombosis, vasculitis, cardiomyopathy, and stroke. Thrombosis and inflammation are implicated in various non-communicable diseases (NCDs). This is of significant concern as people with pre-existing conditions such as cardiovascular disorders, renal disorders, obesity, metabolic syndrome, and diabetes are at greater risk of severe COVID-19 infection. Consequently, the research surrounding the use of anticoagulants, antiplatelet, and antithrombotic strategies for prophylaxis and treatment of COVID-19 is of critical importance. The adoption of a healthy diet, physical exercise, and lifestyle choices can reduce the risk factors associated with NCDs and the thrombo-inflammatory complications. In this review, these thrombotic complications and potential foods, nutraceuticals, and the antithrombotic constituents within that may prevent the onset of severe thrombotic complications as a result of infection are discussed. While nutrition is not a panacea to tackle COVID-19, it is apparent that a patient's nutritional status may affect patient outcomes. Further intensive research is warranted to reduce to incidence of thrombotic complications.
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Lipid profile is associated with decreased fatigue in individuals with progressive multiple sclerosis following a diet-based intervention: Results from a pilot study.
Fellows Maxwell, K, Wahls, T, Browne, RW, Rubenstein, L, Bisht, B, Chenard, CA, Snetselaar, L, Weinstock-Guttman, B, Ramanathan, M
PloS one. 2019;14(6):e0218075
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Fatigue is a frequent and debilitating symptom of multiple sclerosis (MS) and is independent of level of disability. The authors previously reported that a 12 months diet and lifestyle intervention was effective at reducing fatigue in patients with progressive MS. The aims of this study were to characterise the changes in lipid and cholesterol biomarkers during the intervention, and to investigate whether these biomarkers were associated with fatigue outcomes. Data of 18 MS patients were analysed. The intervention consisted of a modified Paleolithic diet, supplemented with exercise, neuromuscular electrical stimulation (NMES) and stress reduction techniques (Wahl’s protocol). Fatigue was significantly decreased at 3, 6, 9 and 12 months compared to baseline, and more so in those having more of the recommended foods and less of the excluded foods. The exercise, NMES, and stress reduction components of the intervention were not associated with changes in fatigue. All variables of the lipid profiles improved during the 12 months intervention. These improvements were associated with the changes in nutrient intakes, in particular, with amounts and types of fat, carbohydrates and fibre. Changes in total and HDL cholesterol, but not LDL cholesterol or triglycerides were associated with a decrease in fatigue. The authors hypothesise that the benefits of the changes in lipid profile on fatigue may be mediated by the positive effects of HDL-cholesterol on mitochondrial function (mitochondria are the “power houses” of every cell, i.e. produce energy on the cellular level), in particular those in the muscles. Limitations of the study include the small sample size, lack of control group and randomisation. The authors conclude that diet-induced changes in HDL and total cholesterol may mediate the positive effects of a dietary and lifestyle intervention on fatigue in MS patients.
Abstract
PURPOSE To investigate associations between lipid profiles and fatigue in a cohort of progressive multiple sclerosis (MS) patients on a diet-based multimodal intervention. METHODS This pilot study included 18 progressive MS patients who participated in a prospective longitudinal study of fatigue following a diet-based multimodal intervention that included exercise, neuromuscular electrical stimulation and stress reduction. The diet recommended high intake of vegetables and fruits, encouraged consumption of animal and plant protein and excluded foods with gluten-containing grains, dairy and eggs. Fatigue was measured on the Fatigue Severity Scale (FSS) at baseline and every 3 months for 12 months. A lipid profile consisting of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglycerides (TG) was obtained on fasting blood samples at baseline and 12 months. RESULTS FSS scores decreased from a baseline of 5.51 (95% CI: 4.86, 6.16) to a mean of 3.03 (95% CI: 2.23, 3.82) at 12 months (p < 0.001). At 12 months, increases in HDL-C (mean change: +6.0 mg/dl; 95% CI: 0.3, 12.0; p = 0.049) and decreases in BMI (mean change: -2.6 kg/m2; 95% CI: -3.6, -2.5; p < 0.001), LDL-C (mean change: -10.4 mg/dl; 95% CI:-19.7, -1.2; p = 0.029), TG (mean change: -29.2 mg/dl; 95% CI: -44.3, -14.2; p = 0.001), TG to HDL-C ratio (mean change: -0.6; 95% CI: -1.0, -0.3; p = 0.002) and TC to HDL-C ratio (mean change:-0.6; 95% CI: -1.0, -0.3; p = 0.003) were observed compared to baseline. Improvements in FSS were associated with increases in HDL-C (β = -0.05; 95% CI: -0.1, -0.0004; p = 0.048) and changes in TC (p = 0.005) from baseline to 12 months. CONCLUSIONS Lipid profile variables are associated with improvements in fatigue in progressive MS patients on a diet-based multimodal intervention.
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4.
Nutritional Challenges in Metabolic Syndrome.
Hoyas, I, Leon-Sanz, M
Journal of clinical medicine. 2019;8(9)
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Metabolic syndrome is a cluster of symptoms and risk factors for cardiovascular disease where the main therapeutic treatment is focused on weight loss and improvements in insulin sensitivity. However, there is no one dietary therapy that works for everyone, so weight reduction is often approached differently. Common dietary plans involve calorie reduction, low-carbohydrate, low-fat or a lifestyle-based approach such as the Mediterranean diet. What is scientifically accepted is that the different macronutrients each play a role in promoting weight loss. An elevated intake of high GI carbohydrates can cause insulin resistance over time. High fibre foods can help mitigate this as well as supporting satiety. There is a lot more focus on low carb, low GI and ketogenic diets. Fat intake has also been studied intensely and different lipids can influence cholesterol and other cardiovascular markers. Omega-3 fatty acids have been shown to be especially healthful. Limiting saturated and trans fats, added sugars, and sodium is also considered a healthy pattern. Proteins are associated with increased satiety and maintaining muscle mass. Each dietary pattern has a different metabolic effect although calorie restriction is typically the more effective intervention for metabolic intervention.
Abstract
Metabolic Syndrome (MetS) is a combination of risk factors for the development of cardiovascular disease (CVD) and type 2 diabetes. Different diagnostic criteria were proposed, but a consensus was reached in 2009 based on values of waist circumference, blood pressure, fasting glycemia, triglycerides, and high-density lipoprotein (HDL)-cholesterol levels. The main underlying etiologic factor is insulin resistance. The quality and quantity of individual macronutrients have an influence on the development and resolution of this syndrome. However, the main treatment goal is weight loss and a decrease in insulin resistance. A controlled energy dietary recommendation, together with moderate levels of physical activity, may positively change the parameters of MetS. However, there is no single dietary or exercise prescription that works for all patients. Dietary patterns such as Mediterranean-style, dietary approaches to stop hypertension (DASH), low-carbohydrate, and low-fat diets can ameliorate insulin resistance and MetS. Long-term adherence to a healthy lifestyle is key in assuring that individuals significantly reduce the risk of CVD and diabetes mellitus.
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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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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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A randomised trial of the feasibility of a low carbohydrate diet vs standard carbohydrate counting in adults with type 1 diabetes taking body weight into account.
Krebs, JD, Parry Strong, A, Cresswell, P, Reynolds, AN, Hanna, A, Haeusler, S
Asia Pacific journal of clinical nutrition. 2016;25(1):78-84
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With the advent of self-managed insulin by injection, Type 1 diabetics were able to eat a normal diet and not worry about their carbohydrate intake. However this regime requires careful carbohydrate counting and insulin dosing, which is not always easy to do. With interest in low carbohydrate diets in the management of Type 2 diabetes increasing, some Type 1 diabetics are restricting their carbohydrates in order to better control their blood glucose levels. This pilot study was a small, single-blinded randomised control trial of 10 individuals. It aimed to determine the effects of low carbohydrate diets on glycaemic control, daily insulin requirements and quality of life in Type 1 Diabetes, when compared to those on a normal diet. The results showed that HbA1C reduced significantly in the carbohydrate restricted group compared to the group eating a normal diet. The amount of injected insulin also showed a significant reduction in the low-carbohydrate group. There were no changes in blood pressure, creatinine or lipid profile in either of the groups. A low-carbohydrate diet is a feasible option for clients with Type 1 Diabetes who are looking for improved glycaemic control and reduced doses of insulin, particularly if they would like to lose weight.
Abstract
BACKGROUND AND OBJECTIVES To determine the effect of a low carbohydrate diet and standard carbohydrate counting on glycaemic control, glucose excursions and daily insulin use compared with standard carbohydrate counting in participants with type 1 diabetes. METHODS AND STUDY DESIGN Participants (n=10) with type 1 diabetes using a basal; bolus insulin regimen, who attended a secondary care clinic, were randomly allocated (1:1) to either a standard carbohydrate counting course or the same course with added information on following a carbohydrate restricted diet (75 g per day). Participants attended visits at baseline and 12 weeks for measurements of weight, height, blood pressure, HbA1c, lipid profile and creatinine. They also completed a 3-day food diary and had 3 days of continuous subcutaneous glucose monitoring. RESULTS The carbohydrate restricted group had significant reductions in HbA1c (63 to 55 mmol/mol (8.9-8.2%), p<0.05) and daily insulin use (64.4 to 44.2 units/day, p<0.05) and non-significant reductions in body weight (83.2 to 78.0 kg). There were no changes in blood pressure, creatinine or lipid profile and all outcomes in the carbohydrate counting group were unchanged. There was no change in glycaemic variability as measured by the mean amplitude of glycaemic excursion in either group. CONCLUSIONS A low carbohydrate diet is a feasible option for people with type 1 diabetes, and may be of benefit in reducing insulin doses and improving glycaemic control, particularly for those wishing to lose weight. 背景与目的:在1 型糖尿病患者中,与标准碳水化合物计数比较,确定低碳水 化合物饮食对血糖控制、血糖波动以及每日胰岛素使用的影响。方法与研究 设计:参加二级保健门诊使用普通膳食以注射胰岛素为治疗方案的10 例1 型 糖尿病患者,按照1:1 的比例随机分配到一个标准的碳水化合物计数组,或限 制碳水化合物饮食组(每天75 g)。测量了所有志愿者基线和12 周的体重、 身高、血压、糖化血红蛋白、血脂和肌酐,志愿者完成了为期3 天的食物日记 和3 天持续皮下血糖监测。结果:碳水化合物限制组HbA1c(63-55 mmol/mol (8.9-8.2 %),p<0.05)和每日胰岛素用量(64.4-44.2 U/d,p<0.05)显著减 少,体重(83.2-78 kg)的变化无显著差异。碳水化合物计数组血压、肌酐或 血脂所有指标均无显著改变。通过平均血糖波动幅度计算的血糖变异性在任何 一组中均无改变。结论:低碳水化合物饮食是1 型糖尿病患者一个可行的选 择,可以减少胰岛素剂量和改善血糖控制,特别是对那些希望减肥的患者。.