Prediabetes conversion to Normoglycemia is superior adding a low-carbohydrate and energy deficit formula diet to lifestyle intervention - a 12-month subanalysis of the ACOORH trial

Lifestyle interventions have been shown to reverse hyperglycemia to normoglycemia. However, these effects are not long-lasting and are accompanied with high dropout rates. As formula diets have been shown to be simple in usage and effective in improving glycemic control, we hypothesised that adding a low-carbohydrate and energy deficit formula diet to a low-intensity lifestyle intervention is superior in reversing prediabetes compared with lifestyle intervention alone. In this predefined subanalysis of an international, multicenter randomised controlled trial (Almased Concept against Overweight and Obesity and Related Health Risk (ACOORH) study (ID DRKS00006811)), 141 persons with prediabetes were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 45) or a lifestyle intervention group accompanied with a formula diet (INT, n = 96). Both groups were equipped with telemonitoring devices. INT received a low-carbohydrate formula diet substituting three meals/day (~1200 kcal/day) within the first week, two meals/day during week 2–4, and one meal/day during week 5–26 (1300–1500 kcal/day). Follow-up was performed after 52 weeks and 105 participants (75%, INT: n = 74; CON: n = 31) finished the 26-week intervention phase. Follow-up data after 52 weeks were available from 93 participants (66%, INT: n = 65; CON: n = 28). Compared with CON, significantly more INT participants converted to normoglycemia after 52 weeks (50% vs. 31%; p 0.05). The risk reduction led to a number-needed-to-treat of 5.3 for INT. Lifestyle intervention with a low-carbohydrate formula diet reduces prediabetes prevalence stronger than lifestyle intervention alone and is effective for type 2 diabetes prevention

High-protein, low-glycaemic meal replacement decreases fasting insulin and inflammation markers — a 12-month subanalysis of the ACOORH trial

Abstract: Lifestyle interventions, including meal replacement, are effective in the prevention and treatment of type-2-diabetes and overweight. Since insulin is the key weight regulator, we hypothesised that addition of meal replacement to a lifestyle intervention reduces insulin levels more effective than lifestyle intervention alone. In the international, multicenter randomised-controlled ACOORH-trial (Almased-Concept-against-Overweight-and-Obesity-and-Related-Health-Risk) overweight or obese persons with criteria of metabolic syndrome (n=463) were randomised into two groups. Both groups received nutritional advice focussing on carbohydrate restriction and telemonitoring devices. The intervention group substituted all three main meals/day in week 1, two meals/day in week 2–4, and one meal/day in week 5–26 with a protein-rich, low-glycaemic meal replacement. Data were collected at baseline, after 1, 3, 6 and 12 months. All datasets providing insulin data (n=446) were included in this predefined subanalysis. Significantly stronger reductions of insulin (-3.3±8.7μU/ml vs. -1.6±9.8μU/ml), weight (-6.1±5.kg vs. -3.2±4.6kg) and inflammation markers were observed in the intervention group. Insulin reduction correlated with weight reduction and strongest weight loss (-7.6±4.9kg) was observed in those participants with insulin decrease >2μU/ml. These results underline the potential of meal replacement-based lifestyle interventions in diabetes prevention, and measurement of insulin may serve as an indicator for adherence to carbohydrate restriction

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

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

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

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 ( = 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 ( = 427) were included in this predefined subanalysis. Serum leptin levels significantly correlated with sex, body mass index, weight, and fat mass at baseline ( < 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; < 0.001 each) and was predictive for stronger reduction of body weight and fat mass ( < 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 ( < 0.0001); -6.8 ± 5.3 kg vs. -4.1 ± 4.4 kg ( = 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

Individualized Meal Replacement Therapy Improves Clinically Relevant Long-Term Glycemic Control in Poorly Controlled Type 2 Diabetes Patients

Background Formula diets can improve glycemic control or can even induce remission in type 2 diabetes. We hypothesized that especially an individualized intense meal replacement by a low-carbohydrate formula diet with accompanied self-monitoring of blood glucose (SMBG) contributes to long-term improvements in HbA1c, weight, and cardiometabolic risk factors in poorly controlled type 2 diabetes. Methods Type 2 diabetes patients were randomized into either a moderate group (M-group) with two meal replacements/day (n = 160) or a stringent group (S-group) with three meal replacements/day (n = 149) during the first week of intervention (1300–1500 kcal/day). Subsequently, both groups reintroduced a low-carbohydrate lunch based on individual adaption due to SMBG in weeks 2–4. After week 4, breakfast was reintroduced until week 12. During the follow-up period, all of the participants were asked to continue replacing one meal per day until the 52-weeks follow-up. Additionally, an observational control group (n = 100) remained in routine care. Parameters were compared at baseline, after 12 and 52 weeks within and between all of the groups. Results 321 participants (83%) completed the acute meal replacement phase after 12 weeks and 279 participants (72%) the whole intervention after 52 weeks. Both intervention groups achieved improvements in HbA1c, fasting blood glucose, blood pressure, and weight (all p < 0.001) within 12 weeks. However, these results were not significantly different between both of the intervention groups. The estimated treatment difference in HbA1c reduction was (mean (95% confidence interval [CI]) -0.10% with 95% CI [−0.40; 0.21] also (p > 0.05) (S-group vs. M-group) not statistically different after 12 weeks. However, only the S-group showed a clinically relevant improvement in HbA1c of −0.81% [−1.06; −0.55] (p < 0.001) after 52 weeks of follow-up, whereas HbA1c was not statistically different between the M- and control group. Conclusion Individualized meal replacement with SMBG demonstrated beneficial effects on HbA1c and cardiometabolic parameters in type 2 diabetes. Furthermore, the initiation of a weight loss program with one week of full meal replacement (three meals per day) resulted in a clinically relevant long-term HbA1c reduction, as compared to an observational control group that had standard care

Weight Reduction by the Low-Insulin-Method—A Randomized Controlled Trial

Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (−6.3 kg with (95% confidence interval) (−7.4; −4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by −6.7 kg (−9.5; −3.8) (p < 0.001) and −6.1 kg (−9.2; −2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity

Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial

Background. Lifestyle interventions have shown to be effective when continuous personal support was provided. However, there is lack of knowledge whether a telemedical-approach with personal coaching contributes to long-term weight losses in overweight employees. We, therefore, tested the hypothesis that telemedical-based lifestyle interventions accompanied with telemedical coaching lead to larger weight losses in overweight persons in an occupational health care setting. Methods. Overweight employees (n=180) with a body mass index (BMI) of >27 kg/m2 were randomized into either a telemedical (TM) group (n=61), a telemedical coaching (TMC) group (n=58), or a control group (n=61). Both intervention groups were equipped with scales and pedometers automatically transferring the data into a personalized online portal, which could be monitored from participants and coaches. Participants of the TMC group received additionally one motivational care call per week by mental coaches to discuss the current data (current weight and steps) and achieving goals such as a healthy lifestyle or weight reduction. The control group remained in routine care. Clinical and anthropometric data were determined after the 12-week intervention. Additionally, weight change was followed up after 12 months. Results. Participants of TMC (-3.1 ± 4.8 kg, p<0.0001) and TM group (-1.9 ± 4.0 kg; p=0.0012) significantly reduced weight and sustained it during the 1-year follow-up, while the control group showed no change. Compared to the control group only weight loss in the TMC group was significantly different (p<0.001) after 12 months. TMC and TM group also reduced BMI, waist circumference, and LDL cholesterol. Moreover, TMC group improved additionally systolic and diastolic blood pressure, total cholesterol, HDL cholesterol, and HbA1c. Conclusions. Telemedical devices in combination with telemedical coaching lead to significant long-term weight reductions in overweight persons in an occupational health care setting. This study is registered with NCT01868763, ClinicalTrials.gov

Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting

Background: Self-monitoring of blood glucose using capillary glucose testing (C) has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood (IV) as a reference. Postprandial blood glucose levels were measured after 50 g oral glucose load and after the consumption of a portion of different foods containing 50 g of carbohydrates. We also evaluated the associations between postprandial glucose responses and the clinical characteristics of the participants at the beginning of the study. Methods: 12 healthy volunteers (age: 36 &plusmn; 17 years, BMI: 24.9 &plusmn; 3.5 kg/m2) ate white bread (WB) and whole grain (WG) bread and drank a 50 g glucose drink as reference. Postprandial glucose responses were evaluated by CGM, IV and C blood glucose measurements. Incremental area under the curve (AUCi) of postprandial blood glucose was calculated for 1 h (AUCi 0-60) and 2 h (AUCi 0-120). Results: After the consumption of white bread and whole grain bread, the AUCi 0-60 min did not differ between CGM and IV or C. AUCi 0-120 min of CGM showed no difference compared to C. Correlation analyses revealed a positive association of age with glucose AUCi 0-120 (r = 0.768; P = 0.004) and WG AUCi 0-120 (r = 0.758; P = 0.004); fasting blood glucose correlated with WG AUCi 0-120 (r = 0.838; P &lt; 0.001). Conclusion: Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions. Associations of AUCi 0-60 and AUCi 0-120 postprandial glucose response with age or fasting blood glucose could be shown

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

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