Changes in Bone Mineral Density Following Weight Loss Induced by One-Anastomosis Gastric Bypass in Patients with Vitamin D Supplementation.

BACKGROUND: Little is known about changes in bone mineral density (BMD) following weight loss after one-anastomosis gastric bypass (OAGB) and the role of serum vitamin D and its supplementation on bone metabolism. We evaluated BMD after OAGB as a function of vitamin D supplementation with respect to a minimum threshold of 25-hydroxy-vitamin-D [25(OH)D] concentration, which could prevent or decelerate an eventual bone loss. METHODS: Fifty bariatric patients who participated in the randomized controlled trial were included in this analysis. BMD and anthropometric measurements by DXA and laboratory parameters were assessed before (T0), at 6 (T6), and 12 months (T12) after surgery. RESULTS: OAGB resulted in a 36% total body weight loss with a decrease in body fat and an increase in lean body mass. A significant decrease in BMD was seen in lumbar spine by 7%, left hip 13%, and total body 1%, but not in forearm. Bone turnover markers increased significantly but with normal parathyroid hormone concentrations. Weight loss was not associated with changes in BMD. A serum 25(OH)D concentration > 50 nmol/l at T6 and T12 (adequate-vitamin-D-group; AVD) showed a significant lower bone loss, compared to the inadequate-vitamin-D-group (IVD; < 50 nmol/l). Lower bone loss in the left hip showed a strong correlation with higher 25(OH)D concentrations (r = 0.635, p = 0.003). CONCLUSION: These findings support a dose effect of vitamin D supplementation on bone health and suggest that 25(OH)D concentrations need to be above 50 nmol/l at least during the first postoperative year to decelerate bone loss in patients undergoing OAGB. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: Clinicaltrials.gov (NCT02092376) at https://clinicaltrials.gov /. EudraCT (2013-003546-16) at https://eudract.ema.europa.eu /.

Gradual reduction of free sugars in beverages on sale by implementing the beverage checklist as a public health strategy.

Background: Sugar-sweetened beverages (SSBs) are a major source of free sugar intake and contribute to obesity and obesity-related diseases. Therefore, we analyzed the effect of a gradual sugar reduction strategy within the so-called 'beverage checklist' on free sugar content in beverages on sale in Austria. Methods: From 2010 until 2017, data on the amount of free sugar of sweetened beverages (sweetened with sugars, fruit juice and artificial sweeteners) with 0.20-0.75l serving sizes in all main supermarkets and from industry was collected. These data were published annually as the beverage checklist, which displays beverages on sale in Austria. The checklist aims to encourage beverage production with a free sugar content of ≤7.4 g/100 ml and no artificial sweeteners. Results: Free sugar content in the total supply decreased significantly [7.53 (2.86) vs. 6.75 (2.79) g/100 ml; 10.4%; P < 0.001] over time and also in those for which follow-up data were available until 2017 (n = 100) [7.55 (2.46) vs. 7.28 (2.44) g/100 ml; 3.5%; P < 0.001]. The percentage of beverages fulfilling the guiding criteria increased by 12.8% (P < 0.001) and of those containing sweeteners decreased by 13.3% (after 2012; P = 0.034). Conclusions: This public health strategy, conducted by a small non-profit organization, showed a reduction in the mean free sugar content by working with the industry to voluntarily reformulate beverages. More beverages with less added sugar were brought to the market, which implies healthier choices. The challenge now is to further engage the industry and also policy makers to achieve a greater reduction in the future.

Using digital photography in a clinical setting: a valid, accurate, and applicable method to assess food intake.

BACKGROUND/OBJECTIVES: Regular monitoring of food intake is hardly integrated in clinical routine. Therefore, the aim was to examine the validity, accuracy, and applicability of an appropriate and also quick and easy-to-use tool for recording food intake in a clinical setting. SUBJECTS/METHODS: Two digital photography methods, the postMeal method with a picture after the meal, the pre-postMeal method with a picture before and after the meal, and the visual estimation method (plate diagram; PD) were compared against the reference method (weighed food records; WFR). A total of 420 dishes from lunch (7 weeks) were estimated with both photography methods and the visual method. Validity, applicability, accuracy, and precision of the estimation methods, and additionally food waste, macronutrient composition, and energy content were examined. RESULTS: Tests of validity revealed stronger correlations for photography methods (postMeal: r = 0.971, p < 0.001; pre-postMeal: r = 0.995, p < 0.001) compared to the visual estimation method (r = 0.810; p < 0.001). The pre-postMeal method showed smaller variability (bias < 1 g) and also smaller overestimation and underestimation. This method accurately and precisely estimated portion sizes in all food items. Furthermore, the total food waste was 22% for lunch over the study period. The highest food waste was observed in salads and the lowest in desserts. CONCLUSIONS: The pre-postMeal digital photography method is valid, accurate, and applicable in monitoring food intake in clinical setting, which enables a quantitative and qualitative dietary assessment. Thus, nutritional care might be initiated earlier. This method might be also advantageous for quantitative and qualitative evaluation of food waste, with a resultantly reduction in costs.

Sugar-Sweetened Beverages and Weight Gain in Children and Adults: A Systematic Review from 2013 to 2015 and a Comparison with Previous Studies.

OBJECTIVE: Partly inconsistent findings from previous reviews have fueled discussions on the impact of sugar-sweetened beverages (SSBs) on obesity development. The aim was to systematically review the recent evidence in children and adults. METHODS: Data were retrieved from the databases MEDLINE, EMBASE, and Cochrane library for the period January 2013 to October 2015. A systematic review of prospective cohort studies and randomized controlled trials (RCTs) relating SSBs to weight measures was conducted. RESULTS: 30 publications met the inclusion criteria. Prospective cohort studies (96%; n = 26) showed a positive association between consumption of SSBs and weight/BMI in adults and children (n = 242,352), and only one cohort study in children showed no association. Findings from three RCTs in children demonstrated that SSB consumption had an effect on BMI/BMI z-score. The one RCT in adults showed no significant effect of the intervention. 63% of the studies were of good, 30% of medium quality, and none was funded by industry. CONCLUSION: Recent evidence suggests that SSB consumption is positively associated with or has an effect on obesity indices in children and adults. By combining the already published evidence with the new one, we conclude that public health policies should aim to reduce the consumption of SSBs and encourage healthy alternatives such as water.

Long-Term Weight-Loss Maintenance by a Meal Replacement Based Weight Management Program in Primary Care.

OBJECTIVE: Structured obesity treatment programs at primary care level are becoming increasingly important. However, evidence from current treatment approaches in the long term is lacking. In view of this fact we evaluated a standardized, meal replacement-based weight loss program (myLINE®; AENGUS, Graz, Austria) according to the currently applicable guidelines. METHODS: Data of overweight and obese individuals (n = 70) who participated at least 36 months in the program were analyzed. Data were collected at baseline (T0) as well as after 1, 3, 6, 12, 24, and 36 (T1-T36) months. Body composition was measured by conventional anthropometry and bioelectrical impedance analysis. RESULTS: Compared to T0, a maximum weight, BMI, fat mass, absolute body cell mass (BCM) reduction and an increase of relative BCM could be seen at T6. Subsequently, the findings reveal a significant reduction of body weight and body fat and a satisfying development of body cell mass during the observation period of 36 months. CONCLUSION: The evaluated program complies with national and international guidelines for the therapy of obesity in adults and is efficient and meaningful for a long-term therapeutic use in primary care..

Vitamin D3 Loading Is Superior to Conventional Supplementation After Weight Loss Surgery in Vitamin D-Deficient Morbidly Obese Patients: a Double-Blind Randomized Placebo-Controlled Trial.

BACKGROUND: Bariatric patients often suffer from vitamin D deficiency (VDD), and both, morbid obesity and VDD, are related to non-alcoholic fatty liver disease. However, limited data are available regarding best strategies for treating VDD, particularly, in bariatric patients undergoing omega-loop gastric bypass (OLGB). Therefore, we examined the efficacy and safety of a forced vitamin D dosing regimen and intervention effects in liver fibrotic patients. METHODS: In this double-blind, randomized, placebo-controlled trial, 50 vitamin D-deficient patients undergoing OLGB were randomly assigned to receive, in the first month postoperatively, oral vitamin D3 (≤3 doses of 100,000 IU; intervention group) or placebo as loading dose (control group) with subsequent maintenance dose (3420 IU/day) in both groups until 6-month visit. RESULTS: Compared with control group, higher increase of 25(OH)D (67.9 (21.1) vs. 55.7 nmol/L (21.1); p = 0.049) with lower prevalence of secondary hyperparathyroidism (10 vs. 24 %; p = 0.045) was observed in intervention group. No (serious) adverse events related to study medication were found. The loading dose regimen was more effective in increasing 25(OH)D in patients with significant liver fibrosis while this was not the case for conventional supplementation (placebo with maintenance dose) (71.5 (20.5) vs. 22.5 nmol/L (13.8); p = 0.022; n = 14). CONCLUSIONS: Our findings indicate that a high vitamin D3 loading dose, in the first month postoperatively, with subsequent maintenance dose is effective and safe in achieving higher vitamin D concentrations in OLGB patients. Unexpectedly, it is more effective in patients with significant liver fibrosis which is of potentially high clinical relevance and requires further investigation.

The Effect of Roux-en-Y vs. Omega-Loop Gastric Bypass on Liver, Metabolic Parameters, and Weight Loss.

BACKGROUND: Omega-loop gastric bypass (OLGB) results in weight loss (WL) but data on its impact on liver and glucose metabolism compared to Roux-en-Y gastric bypass (RYGB) is lacking. Therefore, the aim of this study was to compare the development of hepatic and metabolic markers as well as WL between the above-mentioned surgical groups during the first postoperative year. METHODS: We retrospectively evaluated the respective parameters in non-diabetic morbidly obese patients who underwent either RYGB (n = 25) or OLGB (n = 25). RESULTS: Compared to RYGB, OLGB showed a greater WL percentage. Liver transaminases dropped in RYGB, while rose in OLGB. No correlation between aspartate transaminase, alanine transaminase, and WL could be detected. Gamma-glutamyltransferase decreased significantly in RYGB over the first 3 months, while it increased in OLGB. We found higher levels of triglycerides, insulin, homeostasis model assessment of insulin resistance (HOMA2-IR), and liver fat percentage in RYGB at baseline, despite matching the groups for age, sex, and BMI. Those differences disappeared, except for triglycerides, within 1 year. All metabolic parameters correlated with WL. CONCLUSION: OLGB results in greater WL but transiently deteriorated several liver parameters in the first postoperative year. This was not associated with WL. The impact of these results on hepatic outcomes such as non-alcoholic steatohepatitis and fibrosis progression requires further studies. In both groups, improved insulin resistance and sensitivity were correlated with higher WL and lower liver fat percentage, respectively.

Prevalence of Liver Fibrosis and its Association with Non-invasive Fibrosis and Metabolic Markers in Morbidly Obese Patients with Vitamin D Deficiency.

BACKGROUND: Morbidly obese patients are at risk for non-alcoholic fatty liver disease (NAFLD) and vitamin D deficiency (VDD). Non-alcoholic steatohepatitis (NASH) is the progressive variant of NAFLD and can advance to fibrosis, cirrhosis, and liver cancer. We aimed to examine prevalence of liver fibrosis and its non-invasive predictors in bariatric patients with VDD (<75 nmol/l). METHODS: Baseline liver biopsy of a randomized controlled trial was performed in 46 patients with omega loop gastric bypass. Clinical, laboratory, and histological data were examined and tested with univariate and multivariable analysis. RESULTS: In total, 80 % were females, aged 42 (SD 13) years with BMI 44 (4) kg/m(2). Twenty-six percent had diabetes mellitus (DM) and 44 % metabolic syndrome (MeS). Seventy-two percent had NASH, 11 % simple steatosis, and 17 % normal liver. In total, 30 % demonstrated significant fibrosis (F ≥ 2) with 9 % of advanced (F3) and 4 % cirrhosis (F4). Increased stages of fibrosis were primarily associated with higher levels of HOMA2-insulin resistance (IR), procollagen type I propeptide (P1NP), lower osteocalcin, albumin-corrected calcium, parathyroid hormone, vitamin D, male sex, and higher age. Other independent risk factors for advanced fibrosis were MeS (OR = 9.3 [0.99-87.5], p = 0.052) and DM (OR = 12.8 [1.2-137.4], p = 0.035). The fibrosis FIB-4 index <10.62 and NAFLD fibrosis score <-26.93 had a negative predictive value of 100 and 96 %, respectively. CONCLUSIONS: Liver fibrosis is frequent in morbidly obese patients with concurrent DM and/or MeS. Increased serum levels of IR, P1NP, lower osteocalcin, and VDD are clinically relevant predictors of fibrosis. Consequently, we suggest that patients with preoperative presence of these markers are at increased risk for liver fibrosis and should be monitored closely.

Changes of dietary patterns during participation in a web-based weight-reduction programme.

OBJECTIVE: To examine the weight-loss success associated with distinct dietary patterns and to determine changes of these dietary patterns during participation in a web-based weight-reduction programme. DESIGN: Factor analysis was used to identify the dietary patterns of twenty-two food groups that were administered in 14 d dietary protocols at baseline and after 3 months. Successful weight loss (≥5% of initial weight) and BMI were calculated. Logistic regression analyses were used to assess the rates of weight-loss success from each dietary pattern and changing or remaining in the initial dietary pattern. A generalised linear mixed model was used to estimate the effects of changing or staying in a dietary pattern on change in BMI. SUBJECTS: Adults (n 1635) aged 18-81 years. SETTING: Users of a web-based weight-reduction programme (2006-2012). RESULTS: Participants who aligned to a healthful dietary pattern at baseline (OR=1·8; 95% CI 1·5, 2·3) and after 3 months (OR=1·5; 95% CI 1·2, 1·9) had a greater chance of successfully losing weight. After adjusting for age, sex, initial dietary pattern and BMI, participants who started with or changed to the healthful dietary pattern had a greater chance of being successful (OR=1·4; 95% CI 1·1, 1·7) and a higher BMI reduction of 0·30 (95% CI 0·2, 0·5) kg/m(2) compared with those who started with or changed to the energy-dense or high-carbohydrate dietary pattern. CONCLUSIONS: A favourable healthful dietary pattern at the beginning and after 3 months was positively associated with anthropometry. However, successful weight loss was feasible in each dietary pattern.

Worksite Prevalence of (un)Diagnosed Cardiovascular Risk Factors From a Health-Check-Program in An Austrian Company.

OBJECTIVE: This investigation aims to determine cardiovascular disease risk profile in a cohort of employees. METHODS: In 704 participants, within the Special Institute for Preventive Cardiology And Nutrition health-check-program, body mass index, waist circumference, blood pressure (BP), lipids, glucose, and 10-year cardiovascular disease risk were assessed. RESULTS: Mean age was 37 (10) years (20% women) with 25.5 (3.9)  kg/m. A total of 38% demonstrated overweight, 44% abdominal obesity, 12% obesity, and 19% metabolic syndrome. We found a significant difference in increased BP versus diagnosed hypertension (47% vs. 14%; P < 0.001). Increasing age was a significant predictor of metabolic syndrome (odds ratio [95% confidence interval] = 1.08 [1.06 to 1.10]; P < 0.001). Ten percent had intermediate and 8% high cardiovascular disease risk. A total of 79% demonstrated at least one risk factor. CONCLUSIONS: We detected high prevalence of risk factors particularly increased BP and abdominal obesity. Workplace prevention programs should aim in initially identifying risk factors and subsequently improving lifestyle.

The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial.

BACKGROUND: Beyond its classical role in calcium homoeostasis and bone metabolism, vitamin D deficiency has been found to be associated with several diseases, including diabetes, non-alcoholic fatty liver disease, and even obesity itself. Importantly, there are limited data on therapeutic strategies for vitamin D deficiency in bariatric patients, and the procedure-specific guidelines may not be sufficient. To improve long-term outcomes, nutritional screening and appropriate supplementation to prevent nutrient deficiencies are urgently needed. Therefore, the aim of this study is to examine effects and safety of a forced dosing regimen of vitamin D versus conventional dose supplementation on vitamin D levels and other parameters in bariatric patients. METHODS/DESIGN: The study includes loading plus repeat dosing compared with repeated administration of vitamin D without a loading dose, according to guidelines, in a prospective, double-blind, randomized controlled trial. Up to a triple oral loading dose is given on day 1, then 2 and 4 weeks after surgery (100,000 IU dose each time), followed by an oral maintenance dose (3420 IU/day). The control group (n = 25) will receive placebo, followed by administration of a standard dose (3420 IU/day). We hypothesize that a significant increase in vitamin D levels will occur in patients in the treatment group (n = 25) by 24 weeks after surgery. Further measurements are aimed at evaluating changes in inflammation, bone turnover, insulin resistance, blood pressure, liver, mental health, and gut microbiota of patients undergoing omega-loop gastric bypass surgery. Furthermore, possible associations between concentrations of vitamin D, the involved enzymes, or vitamin D receptor in adipose and/or liver tissues will be determined. DISCUSSION: To our knowledge, this trial is the first of its kind with this type of vitamin D supplementation in bariatric patients. Its major strength is the design and implementation of evaluation of influencing factors such as liver function, bone health, inflammation, insulin resistance, blood pressure, symptoms of depression, or microbiota. This alternative vitamin D dosing regimen has the potential to be a safe, fast, evidence-based treatment of vitamin D deficiency in bariatric patients. Owing to the increasing number of bariatric patients, it is also of interest to elucidate the link between obesity and vitamin D. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02092376 . Registered on 17 March 2014.

Influence of intravenous thiamine supplementation on blood lactate concentration prior to cardiac surgery: A double-blinded, randomised controlled pilot study.

BACKGROUND: Stress related to surgery and critical illness depletes thiamine, essential in energy metabolism, and might result in high blood lactate concentrations and higher mortality. OBJECTIVES: We hypothesised that thiamine supplementation would increase blood concentration of thiamine and reduce blood lactate concentration postoperatively. Moreover, we aimed to identify the prevalence of, and risk factors for, high blood lactate concentrations. DESIGN: This was a double-blind, randomised controlled pilot study from February to July 2012 including 30 patients scheduled for cardiac surgery with cardiopulmonary bypass. INTERVENTIONS: Patients were assigned randomly to receive thiamine (300 mg in 0.9% Normal saline solution) or placebo (0.9% Normal saline) preoperatively. MAIN OUTCOME MEASURES: One arterial blood sample was taken preoperatively and another postoperatively to measure thiamine concentration, and multiple samples were taken during surgery and ICU stay to determine lactate concentrations. Twenty-four hour urine samples were collected to measure urinary thiamine concentration. Preoperatively, we assessed extracellular mass to body cell mass ratio (ECM/BCM). RESULTS: The mean (SD) age of the patients was 58 (12) years, 73% were overweight, 10% were malnourished and the prevalence of thiamine deficiency was 10%. Patients in the thiamine group had significantly higher blood thiamine concentrations 2 days postoperatively [805.2 ± 289.8 ng g(-1) haemoglobin (Hb)] than those in the placebo group (591.2 ± 100.7 ng g(-1) Hb, P < 0.01). The mean blood lactate concentration changed significantly over time, but did not differ significantly between the groups. Patients with ECM/BCM more than 1 had higher lactate concentrations on admission to ICU than those with ECM/BCM less than 1 (2.1 ± 0.7 vs. 1.7 ± 0.6, P = 0.09) and were at a significantly greater risk of having a higher lactate concentration on ICU admission [odds ratio (OR) 13.5, 95% confidence interval (95% CI) 1.0 to 179.4, P < 0.05]. On the basis of these results, a sample size calculation for a larger study has been facilitated. CONCLUSION: Thiamine supplementation caused normalisation of blood and urine concentrations postoperatively but without a significant reduction in lactate concentration or clinical outcome. Body composition played an important role in lactate formation. Further research focusing on preoperative screening and optimal treatment of high lactate concentrations in this specific population is warranted. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01524315.

Effects of omega-loop gastric bypass on vitamin D and bone metabolism in morbidly obese bariatric patients.

BACKGROUND: Bariatric patients often suffer from nutrient deficiencies. Little is known about vitamin D levels and bone metabolism in patients undergoing omega-loop gastric bypass (OLGB). We, therefore, evaluated parameters of vitamin D metabolism preoperatively and during the first postoperative year. METHODS: Within our cohort study, we retrospectively evaluated the respective parameters pre-, 3, 6, and 12 months postoperatively in patients with OLGB, between February 2011 and February 2013. RESULTS: In patients [n = 50; age 46 (15) years, mean (SD); 12 male, 38 female] BMI was 45.4 (6.6) kg/m(2) preoperatively and decreased to 29.1 (3.8) kg/m(2) after 12 months, corresponding to a total body weight loss of 36 %. Preoperatively, the prevalence of vitamin D deficiency was 96 and 30 % demonstrated elevated parathyroid hormone yielding a prevalence of secondary hyperparathyroidism of 17 %. Postoperatively, subjects received individually adjusted vitamin D3 supplementation (95 % CI 200-3000 IU/day), according to the available guidelines at that time. Nevertheless, every third patient was vitamin D deficient at 12 months (80 %). In patients with preoperative BMI >45 vs. <45 kg/m(2), we observed a 3-fold higher risk for vitamin D deficiency over 12 months [OR = 3.10, 95 % CI (1.01-9.51), p = 0.048]. CONCLUSIONS: To avoid vitamin D deficiency, morbidly obese patients, particularly those with higher preoperative BMI, should be regularly screened pre- and postoperatively. Standard postsurgical supplementation has not been adequate to restore 25-OHD status and current guidelines are not very specific in terms of timing and dosing of vitamin D3 supplementation. Consequently, further trials to enhance the evidence on vitamin D supplementation are warranted.

Evaluation of a meal replacement-based weight management program in primary care settings according to the actual European Clinical Practice Guidelines for the Management of Obesity in Adults.

INTRODUCTION: The purpose of this study was the evaluation of a weight loss program in primary care settings with respect to the European Clinical Practice Guidelines for the Management of Obesity in Adults with regard to the long-term success of changes in body weight and composition. METHODS: Overweight and obese patients (n = 1167) who underwent a standardized meal replacement-based weight loss program (myLINE(®), AENGUS, Austria) in primary care settings were included in this evaluation. Body composition was measured by conventional anthropometry and bioelectrical impedance analysis (AKERN BIA101(®), BIACORPUS RX4000(®), SoftwareBodycomp Version 8.4 Professional). Data of patients who participated at least 12 months in the program were analyzed retrospectively and compared with their baseline data. RESULTS: After 12 months, a weight loss of 8.6 ± 7.5 kg (mean ± standard deviation) or 8.2 ± 7.8 % from baseline was seen (p < 0.001). In all, 71.9 % of all patients achieved a minimal weight loss of 5 %, and 18.8 % lost 15 % of their initial weight. In comparison with the baseline (35.7 ± 11.5 kg), body fat decreased to 29.6 ± 10.7 kg, which is 83.7 ± 18.9 % from baseline (100 %; p < 0.001). Body cell mass showed an absolute reduction of - 1.4 ± 2.2 kg (p < 0.001), although a relative increase of 1.5 ± 2.5 % (p < 0.001). There were no significant differences between male and female subjects regarding changes in weight, body fat, and body cell mass. CONCLUSION: The evaluated program complies with the European Clinical Practice Guidelines for Management of Obesity in Adults (2008), which recommend a weight reduction of 5-15 % from initial weight within 6 months. Furthermore, the data showed a significant reduction of body fat and a relative increase of body cell mass.

Nutritional intervention and physical training in malnourished frail community-dwelling elderly persons carried out by trained lay "buddies": study protocol of a randomized controlled trial.

BACKGROUND: In elderly persons frailty and malnutrition are very common and can lead to serious health hazards such as increased mortality, morbidity, dependency, institutionalization and a reduced quality of life. In Austria, the prevalence of frailty and malnutrition are increasing steadily and are becoming a challenge for our social system. Physical training and adequate nutrition may improve this situation. METHODS/DESIGN: In this randomized controlled trial, 80 malnourished frail community-dwelling patients (≥ 65 years) hospitalized at wards for internal medicine are recruited. Additionally, 80 lay volunteers (≥ 50 years), named buddies are recruited and subsequently trained regarding health enhancing physical activity and nutrition in four standardized training sessions. These buddies visit the malnourished frail persons at home twice a week for about one hour during an initial period of 10-12 weeks. While participants allocated to the intervention group (n = 40) receive intervention to improve their fluid intake, protein and energy intake, perform strength training and try to increase their baseline activities, the control group (n = 40) only gets home visits without any intervention. After 10-12 weeks, both, the intervention and the control group, receive the nutritional intervention and the physical training. Health, nutritional and frailty status, physical fitness, body composition and chronic inflammation of buddies and frail persons are recorded before the intervention, after 10-12 weeks, 6 and 12 months. DISCUSSION: To your knowledge this trial is the first of its kind to provide nutritional and physical activity interventions to malnourished frail community-dwelling persons by trained lay buddies, in which an improvement of the frail persons' and the buddies' health status is measured. This study assesses the efficacy of such an intervention and may offer new perspectives for the management of frailty and malnutrition. TRIAL REGISTRATION: [corrected] ClinicalTrials.gov, NCT01991639.