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Lifestyle intervention reduces risk score for cardiovascular mortality in company employees with pre-diabetes or diabetes mellitus - A secondary analysis of the PreFord randomized controlled trial with 3 years of follow-up.
Brinkmann, C, Hof, H, Gysan, DB, Albus, C, Millentrup, S, Bjarnason-Wehrens, B, Latsch, J, Herold, G, Wegscheider, K, Heming, C, et al
Frontiers in endocrinology. 2023;:1106334
Abstract
AIM: To evaluate the effects of a multimodal intervention (including exercise training, psychosocial interventions, nutrition coaching, smoking cessation program, medical care) on the health and long-term cardiovascular disease (CVD) mortality risk of company employees with pre-diabetes or diabetes mellitus (DM) at high CVD risk. METHODS In the PreFord study, German company employees (n=4196) participated in a free-of-charge CVD mortality risk screening at their workplace. Based on their European Society of Cardiology - Systematic Coronary Risk Evaluation score (ESC-SCORE), they were subdivided into three risk groups. High-risk patients (ESC-SCORE≥5%) were randomly assigned to a 15-week lifestyle intervention or usual care control group. Data from patients with pre-DM/DM were analyzed intention-to-treat (ITT: n=110 versus n=96) and per protocol (PP: n=60 versus n=52). RESULTS Body mass index, glycated hemoglobin, total cholesterol, low-density lipoprotein, triglyceride levels as well as systolic and diastolic blood pressure improved through the intervention (ITT, PP: p<0.001). The ESC-SCORE markedly decreased from pre- to post-intervention (ITT, PP: p<0.001). ESC-SCORE changes from baseline differed significantly between the groups, with the intervention group achieving more favorable results in all follow-up visits 6, 12, 24 and 36 months later (at each time point: ITT: p<0.001; PP: p ≤ 0.010). CONCLUSION The study demonstrates the feasibility of attracting employees with pre-DM/DM at high CVD mortality risk to participate in a multimodal lifestyle program following a free CVD mortality risk screening at their workplace. The lifestyle intervention used in the PreFord study shows high potential for improving health of company employees with pre-DM/DM in the long term. ISRCTN23536103.
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Early and Strong Leptin Reduction Is Predictive for Long-Term Weight Loss during High-Protein, Low-Glycaemic Meal Replacement-A Subanalysis of the Randomised-Controlled ACOORH Trial.
Kempf, K, Röhling, M, Banzer, W, Braumann, KM, Halle, M, Schaller, N, McCarthy, D, Predel, HG, Schenkenberger, I, Tan, S, et al
Nutrients. 2022;(12)
Abstract
Lifestyle interventions including meal replacement are suitable for prevention and treatment of obesity and type-2-diabetes. Since leptin is involved in weight regulation, we hypothesised that a meal replacement-based lifestyle intervention would reduce leptin levels more effectively than lifestyle intervention alone. In the international, multicentre, randomised-controlled ACOORH-trial (Almased-Concept-against-Overweight-and-Obesity-and-Related- Health-Risk), overweight or obese participants with metabolic syndrome criteria (n = 463) were randomised into two groups and received telemonitoring devices and nutritional advice. The intervention group additionally used a protein-rich, low-glycaemic meal replacement. Data were collected at baseline, after 1, 3, 6, and 12 months. All datasets providing leptin data (n = 427) were included in this predefined subanalysis. Serum leptin levels significantly correlated with sex, body mass index, weight, and fat mass at baseline (p < 0.0001). Stronger leptin reduction has been observed in the intervention compared to the control group with the lowest levels after 1 month of intervention (estimated treatment difference −3.4 µg/L [1.4; 5.4] for females; −2.2 µg/L [1.2; 3.3] for males; p < 0.001 each) and was predictive for stronger reduction of body weight and fat mass (p < 0.001 each) over 12 months. Strongest weight loss was observed after 6 months (−5.9 ± 5.1 kg in females of the intervention group vs. −2.9 ± 4.9 kg in the control group (p < 0.0001); −6.8 ± 5.3 kg vs. −4.1 ± 4.4 kg (p = 0.003) in males) and in those participants with combined leptin and insulin decrease. A meal replacement-based lifestyle intervention effectively reduces leptin which is predictive for long-term weight loss.
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High-Protein, Low-Glycaemic Meal Replacement Improves Physical Health-Related Quality of Life in High-Risk Persons for Metabolic Syndrome-A Subanalysis of the Randomised-Controlled ACOORH Trial.
Kempf, K, Röhling, M, Banzer, W, Braumann, KM, Halle, M, Schaller, N, McCarthy, D, Predel, HG, Schenkenberger, I, Tan, S, et al
Nutrients. 2022;(15)
Abstract
While obesity impairs health-related quality of life (HRQOL), lifestyle interventions targeting weight reduction have been effective in improving HRQOL. Therefore, we hypothesised that a meal replacement-based lifestyle intervention, which has been shown to successfully reduce weight, would also improve HRQOL more effectively than a lifestyle intervention alone. In the international, multicenter, randomised-controlled ACOORH-trial (Almased-Concept-against- Overweight-and-Obesity-and-Related-Health-Risk), overweight or obese participants with elevated risk for metabolic syndrome (n = 463) were randomised into two groups. Both groups received telemonitoring devices and nutritional advice. The intervention group additionally used a protein-rich, low-glycaemic meal replacement for 6 months. HRQOL was estimated at baseline, after 3 and 12 months, using the SF-36 questionnaire, and all datasets providing HRQOL data (n = 263) were included in this predefined subanalysis. Stronger improvements in the physical component summary (PCS) were observed in the intervention compared to the control group, peaking after 3 months (estimated treatment difference 2.7 [1.2; 4.2]; p < 0.0001), but also in the long-term. Multiple regression analysis demonstrated that insulin levels and the achieved weight loss were associated with the mental component summary (MCS) after 12 months (p < 0.05). Thus, meal replacement-based lifestyle intervention is not only effective in weight reduction but, concomitantly, in enhancing HRQOL.
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A High-Protein and Low-Glycemic Formula Diet Improves Blood Pressure and Other Hemodynamic Parameters in High-Risk Individuals.
Röhling, M, Kempf, K, Banzer, W, Braumann, KM, Führer-Sakel, D, Halle, M, McCarthy, D, Martin, S, Scholze, J, Toplak, H, et al
Nutrients. 2022;(7)
Abstract
Low-caloric formula diets can improve hemodynamic parameters of patients with type 2 diabetes. We, therefore, hypothesized that persons with overweight or obesity can benefit from a high-protein, low-glycemic but moderate-caloric formula diet. This post-hoc analysis of the Almased Concept against Overweight and Obesity and Related Health Risk- (ACOORH) trial investigated the impact of a lifestyle intervention combined with a formula diet (INT, n = 308) compared to a control group with lifestyle intervention alone (CON, n = 155) on hemodynamic parameters (systolic and diastolic blood pressure (SBP, DBP), resting heart rate (HR), and pulse wave velocity (PWV)) in high-risk individuals with prehypertension or hypertension. INT replaced meals during the first 6 months (1 week: 3 meals/day; 2−4 weeks: 2 meals/day; 5−26 weeks: 1 meal/day). Study duration was 12 months. From the starting cohort, 304 (68.3%, INT: n = 216; CON: n = 101) participants had a complete dataset. Compared to CON, INT significantly reduced more SBP (−7.3 mmHg 95% CI [−9.2; −5.3] vs. −3.3 mmHg [−5.9; −0.8], p < 0.049) and DBP (−3.7 mmHg [−4.9; −2.5] vs. −1.4 mmHg [−3.1; 0.2], p < 0.028) after 12 months. Compared to CON, INT showed a pronounced reduction in resting HR and PWV after 6 months but both lost significance after 12 months. Changes in SBP, DBP, and PWV were significantly associated positively with changes in body weight and fat mass (all p < 0.05) and resting HR correlated positively with fasting insulin (p < 0.001) after 12 months. Combining a lifestyle intervention with a high-protein and low-glycemic formula diet improves hemodynamic parameters to a greater extent than lifestyle intervention alone in high-risk individuals with overweight and obesity.
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High-Protein, Low-Glycaemic Meal Replacement Decreases Fasting Insulin and Inflammation Markers-A 12-Month Subanalysis of the ACOORH Trial.
Kempf, K, Röhling, M, Banzer, W, Braumann, KM, Halle, M, McCarthy, D, Predel, HG, Schenkenberger, I, Tan, S, Toplak, H, et al
Nutrients. 2021;(5)
Abstract
Lifestyle interventions, including meal replacement, are effective in the prevention and treatment of type-2-diabetes and obesity. Since insulin is the key weight regulator, we hypothesised that the addition of meal replacement to a lifestyle intervention reduces insulin levels more effectively than lifestyle intervention alone. In the international multicentre randomised controlled ACOORH (Almased Concept against Overweight and Obesity and Related Health Risk) trial, overweight or obese persons who meet the criteria for metabolic syndrome (n = 463) were randomised into two groups. Both groups received nutritional advice focusing on carbohydrate restriction and the use of telemonitoring devices. The intervention group substituted all three main meals per day in week 1, two meals per day in weeks 2-4, and one meal per day in weeks 5-26 with a protein-rich, low-glycaemic meal replacement. Data were collected at baseline and after 1, 3, 6 and 12 months. All datasets providing insulin data (n = 446) were included in this predefined subanalysis. Significantly higher reductions in insulin (-3.3 ± 8.7 µU/mL vs. -1.6 ± 9.8 µU/mL), weight (-6.1 ± 5.2 kg vs. -3.2 ± 4.6 kg), and inflammation markers were observed in the intervention group. Insulin reduction correlated with weight reduction and the highest amount of weight loss (-7.6 ± 4.9 kg) was observed in those participants with an insulin decrease > 2 µU/mL. These results underline the potential for meal replacement-based lifestyle interventions in diabetes prevention, and measurement of insulin levels may serve as an indicator for adherence to carbohydrate restriction.
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Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 2.
Schwaab, B, Bjarnason-Wehrens, B, Meng, K, Albus, C, Salzwedel, A, Schmid, JP, Benzer, W, Metz, M, Jensen, K, Rauch, B, et al
Journal of clinical medicine. 2021;(14)
Abstract
BACKGROUND Scientific guidelines have been developed to update and harmonize exercise based cardiac rehabilitation (ebCR) in German speaking countries. Key recommendations for ebCR indications have recently been published in part 1 of this journal. The present part 2 updates the evidence with respect to contents and delivery of ebCR in clinical practice, focusing on exercise training (ET), psychological interventions (PI), patient education (PE). In addition, special patients' groups and new developments, such as telemedical (Tele) or home-based ebCR, are discussed as well. METHODS Generation of evidence and search of literature have been described in part 1. RESULTS Well documented evidence confirms the prognostic significance of ET in patients with coronary artery disease. Positive clinical effects of ET are described in patients with congestive heart failure, heart valve surgery or intervention, adults with congenital heart disease, and peripheral arterial disease. Specific recommendations for risk stratification and adequate exercise prescription for continuous-, interval-, and strength training are given in detail. PI when added to ebCR did not show significant positive effects in general. There was a positive trend towards reduction in depressive symptoms for "distress management" and "lifestyle changes". PE is able to increase patients' knowledge and motivation, as well as behavior changes, regarding physical activity, dietary habits, and smoking cessation. The evidence for distinct ebCR programs in special patients' groups is less clear. Studies on Tele-CR predominantly included low-risk patients. Hence, it is questionable, whether clinical results derived from studies in conventional ebCR may be transferred to Tele-CR. CONCLUSIONS ET is the cornerstone of ebCR. Additional PI should be included, adjusted to the needs of the individual patient. PE is able to promote patients self-management, empowerment, and motivation. Diversity-sensitive structures should be established to interact with the needs of special patient groups and gender issues. Tele-CR should be further investigated as a valuable tool to implement ebCR more widely and effectively.
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Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors-the ACOORH trial.
Halle, M, Röhling, M, Banzer, W, Braumann, KM, Kempf, K, McCarthy, D, Schaller, N, Predel, HG, Scholze, J, Führer-Sakel, D, et al
European journal of clinical nutrition. 2021;(4):661-669
Abstract
BACKGROUND As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone. METHODS In this multicenter RCT 463 participants with overweight or obesity (BMI: 27-35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2-4, participants replaced two meals/day and during weeks 5-26 only one meal/day was substituted (1300-1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters. RESULTS From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was -3.2 kg [-4.0; -2.5] (P < 0.001) after 12 weeks and -1.8 kg [-2.8; -0.8] (P < 0.001) after 52 weeks. CONCLUSIONS A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.
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Effects of Acute Resistance Exercise with and without Whole-Body Electromyostimulation and Endurance Exercise on the Postprandial Glucose Regulation in Patients with Type 2 Diabetes Mellitus: A Randomized Crossover Study.
Holzer, R, Schulte-Körne, B, Seidler, J, Predel, HG, Brinkmann, C
Nutrients. 2021;13(12)
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Over 460 million people worldwide suffer from Type 2 Diabetes. Previous studies have found that endurance training combined with resistance training increases insulin sensitivity and glucose tolerance. Due to its ability to enhance physical performance and to save time during exercise sessions, electromyostimulation is becoming increasingly popular in health and recreational sports. Using a randomised crossover design, the study measures the effects of different exercise strategies and intensities on glucose regulation post-prandially. To assess the effect of post-prandial glucose regulation on Type 2 Diabetic patients, six patients performed 20 minutes of resistance exercise with whole-body electromyostimulation, conventional exercise without whole-body electromyostimulation, and endurance exercise. All types of exercise were effective at lowering blood glucose levels, even at a short duration of 20 minutes. Electrical stimulation did not affect the effect of exercise in any significant way. It is therefore necessary to conduct further robust long-term studies on the effects of electromyostimulation and resistance or endurance training on lowering postprandial blood glucose levels. The results of this study can be used by healthcare professionals to better understand the relationship between exercise and glucose regulation, which may be useful when making clinical decisions for people with Type 2 Diabetes or obesity.
Abstract
BACKGROUND Long hyperglycemic episodes trigger complications in type 2 diabetes mellitus (T2DM) patients. Postprandial glucose excursions can be reduced by acute physical activity. However, it is not yet clear which type of exercise has the best effect on postprandial glucose levels. METHODS Six T2DM patients participated in three 20-min moderate-intensity exercise sessions after breakfast in a randomized order: resistance exercise with whole-body electromyostimulation (WB-EMS), resistance exercise without electromyostimulation (RES) and cycling endurance exercise (END). A continuous glucose monitoring system recorded glucose dynamics. RESULTS Postprandially-increased glucose levels decreased in all cases. Time to baseline (initial value prior to meal intake) was quite similar for WB-EMS, RES and END. Neither glucose area under the curve (AUC), nor time in range from the start of the experiment to its end (8 h later) differed significantly. A Friedman analysis of variance, however, revealed an overall significant difference for AUC in the post-exercise recovery phase (END seems to have superior effects, but post-hoc tests failed statistical significance). CONCLUSIONS There are no notable differences between the effects of the different types of exercise on glucose levels, especially when comparing values over a longer period of time.
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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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Effects of a Protein-Rich, Low-Glycaemic Meal Replacement on Changes in Dietary Intake and Body Weight Following a Weight-Management Intervention-The ACOORH Trial.
Röhling, M, Stensitzky, A, Oliveira, CLP, Beck, A, Braumann, KM, Halle, M, Führer-Sakel, D, Kempf, K, McCarthy, D, Predel, HG, et al
Nutrients. 2021;(2)
Abstract
Although meal replacement can lead to weight reduction, there is uncertainty whether this dietary approach implemented into a lifestyle programme can improve long-term dietary intake. In this subanalysis of the Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) study (n = 463), participants with metabolic risk factors were randomly assigned to either a meal replacement-based lifestyle intervention group (INT) or a lifestyle intervention control group (CON). This subanalysis relies only on data of participants (n = 119) who returned correctly completed dietary records at baseline, and after 12 and 52 weeks. Both groups were not matched for nutrient composition at baseline. These data were further stratified by sex and also associated with weight change. INT showed a higher increase in protein intake related to the daily energy intake after 12 weeks (+6.37% [4.69; 8.04] vs. +2.48% [0.73; 4.23], p < 0.001) of intervention compared to CON. Fat and carbohydrate intake related to the daily energy intake were more strongly reduced in the INT compared to CON (both p < 0.01). After sex stratification, particularly INT-women increased their total protein intake after 12 (INT: +12.7 g vs. CON: -5.1 g, p = 0.021) and 52 weeks (INT: +5.7 g vs. CON: -16.4 g, p = 0.002) compared to CON. Protein intake was negatively associated with weight change (r = -0.421; p < 0.001) after 12 weeks. The results indicate that a protein-rich dietary strategy with a meal replacement can improve long-term nutritional intake, and was associated with weight loss.