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Effects of intermittent very-low calorie diet on glycemic control and cardiovascular risk factors in obese patients with type 2 diabetes mellitus: A randomized controlled trial.
Umphonsathien, M, Rattanasian, P, Lokattachariya, S, Suansawang, W, Boonyasuppayakorn, K, Khovidhunkit, W
Journal of diabetes investigation. 2022;13(1):156-166
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Various studies have shown that intermittent low-calorie diets are effective in reducing weight and improving glycaemic control. In this randomized controlled trial, two intermittent very-low calorie diets (2 days per week and 4 days per week) were evaluated against a control group with respect to achieving diabetes remission, improving glycemic control, metabolic parameters, and quality of life in Type 2 diabetic patients. There was a significant reduction in HbA1c and insulin resistance in the 2 days/week and 4 days/week intermittent very-low calorie groups at week 20. Both the intervention groups achieved diabetes remission with 29% of participants not requiring glucose-lowering medications at week 20. Both intervention groups also showed a significant reduction in serum triglycerides, body weight, body mass index, and fat mass. Aspartate transaminase and alanine aminotransferase levels, as well as blood pressure, decreased significantly with a 4 day/week intermittent low-calorie diet. Both intervention groups experienced improved quality of life at week 10 and the interventions were generally well tolerated. To generalise the results, longer-term, robust studies are required. These results can help healthcare providers understand the clinical relevance of intermittent very-low calorie diets in managing Type 2 diabetes and obesity.
Abstract
AIMS/INTRODUCTION Very few studies assess the effectiveness of different protocols of intermittent very-low calorie diet (VLCD) in patients with diabetes. This study was designed to compare the effects of 2 days/week and 4 days/week of intermittent VLCD on glycemic control, diabetes remission, metabolic parameters and quality of life in patients with type 2 diabetes and obesity. MATERIALS AND METHODS Participants with obesity and type 2 diabetes were recruited and randomly assigned to three groups, consisting of control, 2 days/week and 4 days/week of intermittent VLCD. In the intermittent VLCD groups, participants received a 600-kcal diet per day on restricted days and ad libitum food consumption on non-restricted days. Glycemic control, rate of diabetes remission, metabolic parameters and quality of life were evaluated at baseline, weeks 2, 10 and 20. RESULTS A total of 40 participants were enrolled. The mean body mass index was 30.1 ± 5.9 kg/m2 , and the mean glycated hemoglobin was 7.4 ± 1.2%. At week 20, there was an improvement in glycemic control in both intermittent VLCD groups with significant decreases in glycated hemoglobin levels and insulin resistance index throughout the study periods. Diabetes remission without the need for medications was equally found in 29% of participants in both intermittent VLCD groups. Serum triglyceride, bodyweight, body mass index and fat mass were also significantly decreased in both VLCD groups. No serious adverse events were encountered. CONCLUSION Intermittent VLCD was highly effective in achieving optimal glycemic control. The effects of 2 days/week and 4 days/week of intermittent VLCD on diabetes remission were relatively similar.
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Effectiveness of a Multicomponent Intervention in Primary Care That Addresses Patients with Diabetes Mellitus with Two or More Unhealthy Habits, Such as Diet, Physical Activity or Smoking: Multicenter Randomized Cluster Trial (EIRA Study).
Represas-Carrera, F, Couso-Viana, S, Méndez-López, F, Masluk, B, Magallón-Botaya, R, Recio-Rodríguez, JI, Pombo, H, Leiva-Rus, A, Gil-Girbau, M, Motrico, E, et al
International journal of environmental research and public health. 2021;18(11)
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Life habits such as smoking, physical activity, and diet affect glycaemic control. The objective of this multicentre randomised cluster trial (EIRA study) was to evaluate the effectiveness of multicomponent educational interventions on glycaemic control in Type 2 diabetic patients. Interventions in multicomponent individual, group and community settings included smoking cessation, the Mediterranean diet and physical activity, as well as an assessment of the quality of life. Participants had unhealthy lifestyles prior to the intervention. The study was conducted in 26 primary healthcare centres in seven health departments in Spain over a period of 12 months. A brief intervention aimed to change the habits of the participants, including increasing physical activity, quitting smoking and adhering to the Mediterranean diet. After 12 months of intervention, there were no statistically significant improvements in glycaemic control, physical activity, sedentary lifestyle, smoking, or quality of life. However, adherence to the Mediterranean diet was statistically significant. Further research is needed to determine the effectiveness of multicomponent interventions in improving glycaemic control. The clinical applicability of multicomponent interventions to tackle type 2 diabetes, obesity, and unhealthy lifestyles should be considered by healthcare providers.
Abstract
Introduction: We evaluated the effectiveness of an individual, group and community intervention to improve the glycemic control of patients with diabetes mellitus aged 45-75 years with two or three unhealthy life habits. As secondary endpoints, we evaluated the inverventions' effectiveness on adhering to Mediterranean diet, physical activity, sedentary lifestyle, smoking and quality of life. Method: A randomized clinical cluster (health centers) trial with two parallel groups in Spain from January 2016 to December 2019 was used. Patients with diabetes mellitus aged 45-75 years with two unhealthy life habits or more (smoking, not adhering to Mediterranean diet or little physical activity) participated. Centers were randomly assigned. The sample size was estimated to be 420 people for the main outcome variable. Educational intervention was done to improve adherence to Mediterranean diet, physical activity and smoking cessation by individual, group and community interventions for 12 months. Controls received the usual health care. The outcome variables were: HbA1c (main), the Mediterranean diet adherence score (MEDAS), the international diet quality index (DQI-I), the international physical activity questionnaire (IPAQ), sedentary lifestyle, smoking ≥1 cigarette/day and the EuroQuol questionnaire (EVA-EuroQol5D5L). Results: In total, 13 control centers (n = 356) and 12 intervention centers (n = 338) were included with similar baseline conditions. An analysis for intention-to-treat was done by applying multilevel mixed models fitted by basal values and the health center: the HbA1c adjusted mean difference = -0.09 (95% CI: -0.29-0.10), the DQI-I adjusted mean difference = 0.25 (95% CI: -0.32-0.82), the MEDAS adjusted mean difference = 0.45 (95% CI: 0.01-0.89), moderate/high physical activity OR = 1.09 (95% CI: 0.64-1.86), not living a sedentary lifestyle OR = 0.97 (95% CI: 0.55-1.73), no smoking OR = 0.61 (95% CI: 0.54-1.06), EVA adjusted mean difference = -1.26 (95% CI: -4.98-2.45). Conclusions: No statistically significant changes were found for either glycemic control or physical activity, sedentary lifestyle, smoking and quality of life. The multicomponent individual, group and community interventions only showed a statistically significant improvement in adhering to Mediterranean diet. Such innovative interventions need further research to demonstrate their effectiveness in patients with poor glycemic control.
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PROFAST: A Randomized Trial Assessing the Effects of Intermittent Fasting and Lacticaseibacillus rhamnosus Probiotic among People with Prediabetes.
Tay, A, Pringle, H, Penning, E, Plank, LD, Murphy, R
Nutrients. 2020;12(11)
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The prevalence of diabetes is increasing worldwide, and with it, the risk of cardiovascular disease is also increasing. Intermittent fasting has been shown to reduce weight and improve glycaemic control. Weight control and glycaemic control were also improved with probiotic Lacticaseibacillus rhamnosus HN001 supplementation. This pilot, 12-week, double-blinded, two-armed, randomized 1:1 study aimed to investigate the combined effects of intermittent fasting with daily probiotic Lacticaseibacillus rhamnosus HN001 supplementation on glycaemic management in participants with prediabetes. For two days, participants restricted their calorie intake to 600-650 kcal, followed by five days of ad libitum consumption (5:2). Intermittent fasting for 12 weeks improved glycaemic control (reduced HbA1c) and reduced body weight by 5%. The supplementation with Lacticaseibacillus rhamnosus HN001 did not significantly improve these outcomes. Probiotic supplementation significantly improved mental health and social functioning in participants. There is a need for further large, robust studies to assess the effects of intermittent fasting alone and when it is combined with different exercise forms and different prebiotic and probiotic supplements on cardiometabolic markers and mental health. The findings of this study may be useful to healthcare professionals in understanding the effects of fasting on metabolism as well as the psychological benefits of Lacticaseibacillus rhamnosus HN001 supplementation.
Abstract
Both intermittent fasting and specific probiotics have shown promise in improving glucose tolerance with a potential for synergistic effects through alterations to gut microbiota. In this randomized, double-blinded, two-arm feasibility study, we investigated whether intermittent fasting, supplemented with Lacticaseibacillus rhamnosus HN001 probiotic, reduces HbA1c in individuals with prediabetes. All participants with HbA1c 40-50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600-650 kcal/day) and were randomized 1:1 to either daily probiotic (Lacticaseibacillus rhamnosus HN001) or placebo for 12 weeks. The primary outcome was a change in HbA1c. Secondary outcomes included changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior. Of 33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m2) completed the intervention (n = 11 placebo, n = 15 probiotic). HbA1c decreased from 43 ± 2.7 mmol/mol to 41 ± 2.3 mmol/mol, p < 0.001, with average of 5% weight loss. No significant between-group differences were seen in primary or secondary outcomes except for social functioning (p = 0.050) and mental health (p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group. This study shows additional psychological benefits of probiotic supplementation during intermittent fasting to achieve weight loss and glycemic improvement in prediabetes.
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The impact of an exercise program on quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy: a randomized controlled trial.
Paulo, TRS, Rossi, FE, Viezel, J, Tosello, GT, Seidinger, SC, Simões, RR, de Freitas, R, Freitas, IF
Health and quality of life outcomes. 2019;17(1):17
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Aromatase inhibitors (which include Tamoxifen) are considered the gold standard treatment in postmenopausal women with breast cancer but may lead to symptoms which have a negative effect on quality of life (QoL). The aim of this randomised controlled study was to evaluate the effect of exercise on QoL in older breast cancer survivors undergoing aromatase inhibitor therapy. 36 women took part in the study, 18 in the exercise group (EX) and 18 in the control group (CN). The EX group attended three supervised exercise sessions per week, consisting of a combination of aerobic and resistance exercise. The CN group attended two relaxation and stretching classes a week. Study duration was nine months. Three different questionnaires were used to assess various aspects of QoL. The study found that combined aerobic and resistance exercise can significantly improve almost all aspects of QoL, including physical, psychological and social functioning. The authors conclude that a combination of aerobic and resistance exercise could be an important strategy to improve health and minimise the side effects of breast cancer treatment in breast cancer survivors.
Abstract
BACKGROUND This study evaluated the impact of an exercise program on quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy. METHODS Older breast cancer survivors were randomized into two groups: combined training: resistance + aerobic exercise program for nine months (n = 18) or control group (n = 18). Quality of life was assessed by the questionnaires SF36, EORTC QLQ-C30, and EORTC QLQ-BR23 at baseline, and at three, six, and nine months. The exercise group performed 40 min of resistance exercises on machines followed by 30 min of aerobic training on a treadmill 3x/wk. Repeated measures ANOVA was used to compare the groups over time. RESULTS Significant time x group interactions and moderate to high effect sizes were found for physical functioning, physical health, bodily pain, general health perception, vitality, social functioning, fatigue, sleep disturbance, body image, and upset by hair loss, favoring the exercise group. CONCLUSION This study demonstrated the potential benefits and high clinical relevance of exercise programs to improve quality of life in older breast cancer survivors undergoing aromatase inhibitor therapy.
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Effect of therapeutic exercise on knee osteoarthritis after intra-articular injection of botulinum toxin type A, hyaluronate or saline: A randomized controlled trial.
Bao, X, Tan, JW, Flyzik, M, Ma, XC, Liu, H, Liu, HY
Journal of rehabilitation medicine. 2018;50(6):534-541
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Knee osteoarthritis is a chronic disease often causing joint pain, swelling and dysfunction. The current treatment options - anti-inflammatory medications, physical therapy or surgery - have been shown to respectively produce adverse side effects, only demonstrate short-term effects or are invasive. The aim of this study was to evaluate the effects of therapeutic exercise after injection of either botulinum toxin type-A (BoNT-A) or hyaluronate in patients with knee osteoarthritis. Sixty patients were randomised to receive an ultrasound-guided injection of BoNT-A, hyaluronate or saline as control, and then participate in a physical therapy session. Therapeutic exercises were then prescribed to patients to complete five times per week. Structural changes in the knee joints were evaluated using imaging tools before and after the intervention, as well as quality of life and pain assessments. While this study found both BoNT-A and hyaluronate resulted in improvements in pain and knee functioning, BoNT-A produced more effective results. The authors conclude this study may provide clinicians with a new, less invasive option for treating patients with knee osteoarthritis.
Abstract
OBJECTIVE To study the effect of therapeutic exercise on knee osteoarthritis after injection of botulinum toxin type A, hyaluronate or saline. METHODS Sixty participants with knee osteoarthritis were randomly assigned to 3 groups: injection of saline (control) (group A), botulinum toxin type A (group B), or hyaluronate (group C). All participants received therapeutic exercise. Western Ontario and McMaster Universities Osteoarthritis Index questionnaire score, visual analogue scale pain scale, and Medical Outcomes Study 36-item Health Survey were conducted at baseline, and at the end of the 4th and 8th weeks. RESULTS At end of the 4th and 8th weeks, the scores on the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and visual analogue scale were higher in the control group. There were significant differences in Physical Component Summary-36 and Mental Component Summary-36 scores between the 3 groups (p <0.05) at the end of the 4th and 8th weeks, but not between groups A (control) and C (hyaluronate) at the end of the 4th week. No changes were seen on magnetic resonance imaging and X-ray images of the affected knees after the intervention. CONCLUSION Therapeutic exercise plus botulinum toxin type A or hyaluronate injection can significantly reduce pain and improve knee functioning. Botulinum toxin type A plus therapeutic exercise appears to be more effective.
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Effects of a ketogenic diet on the quality of life in 16 patients with advanced cancer: A pilot trial.
Schmidt, M, Pfetzer, N, Schwab, M, Strauss, I, Kämmerer, U
Nutrition & metabolism. 2011;8(1):54
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Cancer cells process energy differently to normal cells. Cancer cells rely on glucose as a source of energy, whereas healthy cells can also use fatty acids and protein to make energy. Restricting the level of carbohydrates in the diet therefore could theoretically restrict the amount of energy available to cancer cells. This pilot study investigated the feasibility of a ketogenic diet (KD) and its influence on the quality of life of patients with advanced cancer. Sixteen patients with advanced metastatic tumours participated in the 12-week study. The patients followed a KD (less than 70 g carbohydrate per day) and were provided with a protein/fat shake to take as a snack in the morning and afternoon. Quality of life, blood and urine samples and general health parameters were assessed at baseline, and every two weeks of follow-up. Five patients completed the study. They reported improved emotional functioning and less insomnia, while several other parameters of quality of life remained stable or worsened, reflecting their very advanced disease. Except for temporary constipation and fatigue, there were no severe adverse side effects, and no changes in cholesterol or blood lipids. The authors concluded that a KD is suitable for even advanced cancer patients. It has no severe side effects and might improve aspects of quality of life and blood parameters in some patients with advanced metastatic tumours. However, to judge effects on quality of life or cancer progression, randomised studies with sufficient numbers of patients are needed.
Abstract
BACKGROUND Tumor patients exhibit an increased peripheral demand of fatty acids and protein. Contrarily, tumors utilize glucose as their main source of energy supply. Thus, a diet supplying the cancer patient with sufficient fat and protein for his demands while restricting the carbohydrates (CHO) tumors thrive on, could be a helpful strategy in improving the patients' situation. A ketogenic diet (KD) fulfills these requirements. Therefore, we performed a pilot study to investigate the feasibility of a KD and its influence on the quality of life of patients with advanced metastatic tumors. METHODS Sixteen patients with advanced metastatic tumors and no conventional therapeutic options participated in the study. The patients were instructed to follow a KD (less than 70 g CHO per day) with normal groceries and were provided with a supply of food additives to mix a protein/fat shake to simplify the 3-month intervention period. Quality of life [assessed by EORTC QLQ-C30 (version 2)], serum and general health parameters were determined at baseline, after every two weeks of follow-up, or after drop out. The effect of dietary change on metabolism was monitored daily by measuring urinary ketone bodies. RESULTS One patient did not tolerate the diet and dropped out within 3 days. Among those who tolerated the diet, two patients died early, one stopped after 2 weeks due to personal reasons, one felt unable to stick to the diet after 4 weeks, one stopped after 6 and two stopped after 7 and 8 weeks due to progress of the disease, one had to discontinue after 6 weeks to resume chemotherapy and five completed the 3 month intervention period. These five and the one who resumed chemotherapy after 6 weeks report an improved emotional functioning and less insomnia, while several other parameters of quality of life remained stable or worsened, reflecting their very advanced disease. Except for temporary constipation and fatigue, we found no severe adverse side effects, especially no changes in cholesterol or blood lipids. CONCLUSIONS These pilot data suggest that a KD is suitable for even advanced cancer patients. It has no severe side effects and might improve aspects of quality of life and blood parameters in some patients with advanced metastatic tumors.