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In this trial, obese or overweight adults were randomly assigned to receive the selective serotonin 2C receptor agonist lorcaserin or placebo for 52 weeks, along with diet and exercise counseling. Lorcaserin use, in conjunction with behavioral modification, was associated with significant weight loss, improved maintenance of weight loss, and improved levels of cardiovascular biomarkers. In obese or overweight adults, lorcaserin use in conjunction with behavioral modification was associated with significant weight loss, improved maintenance of weight loss, and improved levels of cardiovascular biomarkers. Activation of the 5-hydroxytryptamine (5-HT, or serotonin) receptor 5-HT 2C decreases food intake through the proopiomelanocortin system of neurons. 1 – 3 Lorcaserin is a small-molecule agonist of the serotonin 2C (5-HT 2C ) receptor designed to promote weight loss. Study of the nonselective serotonergic agonists fenfluramine and dexfenfluramine, which enhance presynaptic serotonin release and block its reuptake, validated serotonin receptors as pharmacologic targets for weight loss. 4 Unfortunately, use of these agents increases the risk of serotonin-associated valvulopathy, 5 – 8 which is thought to occur through agonism of 5-HT 2B receptors expressed on cardiac valvular interstitial cells. 9 – 11 Lorcaserin was designed to selectively . . .

Background/Objectives: Despite advances in public health and medical treatment, the number of patients with type 2 diabetes is increasing and it remains among the top 10 causes of death and a leading cause of disability in the United States. Early interventions with innovative approaches are essential to improving dietary intake and blood glucose control, potentially preventing or delaying type 2 diabetes and related complications. This study examined the effects of integrating real-time feedback from continuous glucose monitoring (CGM) into individualized nutrition therapy (INT) on diet and sleep quality in individuals with prediabetes and overweight or obesity. Methods: Thirty participants were randomized to either the treatment (n = 15) or the control group (n = 15). Both groups received individualized nutrition recommendations tailored to energy needs for weight maintenance and blood glucose control. The treatment group had real-time access to CGM data, while the control group remained blinded. Dietary intake and sleep quality were assessed using ASA24 recall and analyzed via general linear model repeated measures. Results: Incorporating CGM feedback into nutrition therapy significantly increased whole-grain (p = 0.02) and plant-based protein intake (p = 0.02) in the treatment group, with trends toward increased fruit intake (p = 0.07) and a reduced percentage of calories from carbohydrates (p = 0.08). Sleep efficiency also improved significantly by 5% (p = 0.02) following the intervention. Conclusions: These findings support the effectiveness of CGM-enhanced nutrition therapy in improving diet and sleep quality in individuals with prediabetes and overweight or obesity. Further research is needed to assess the sustainability and long-term impact of this approach.

ObjectivesTo determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity.Methods88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests.ResultsThe intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported.ConclusionA VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity.Trial registration numberNIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).

The idea of body weight regulation implies that a biological mechanism exerts control over energy expenditure and food intake. This is a central tenet of energy homeostasis. However, the source and identity of the controlling mechanism have not been identified, although it is often presumed to be some long-acting signal related to body fat, such as leptin. Using a comprehensive experimental platform, we have investigated the relationship between biological and behavioural variables in two separate studies over a 12-week intervention period in obese adults (total n 92). All variables have been measured objectively and with a similar degree of scientific control and precision, including anthropometric factors, body composition, RMR and accumulative energy consumed at individual meals across the whole day. Results showed that meal size and daily energy intake (EI) were significantly correlated with fat-free mass (FFM, P values < 0·02–0·05) but not with fat mass (FM) or BMI (P values 0·11–0·45) (study 1, n 58). In study 2 (n 34), FFM (but not FM or BMI) predicted meal size and daily EI under two distinct dietary conditions (high-fat and low-fat). These data appear to indicate that, under these circumstances, some signal associated with lean mass (but not FM) exerts a determining effect over self-selected food consumption. This signal may be postulated to interact with a separate class of signals generated by FM. This finding may have implications for investigations of the molecular control of food intake and body weight and for the management of obesity.

Background/Objectives: prediabetes is a significant risk factor for the development of type 2 diabetes, cardiovascular diseases, chronic kidney disease, and other complications. Early diagnosis of prediabetes, coupled with education on lifestyle changes that support blood glucose management, are crucial for the prevention or delay of type 2 diabetes and related complications. This study aimed to evaluate the impact of incorporating real-time feedback from continuous glucose monitoring (CGM) into individualized nutrition therapy (INT) on blood glucose control in individuals with prediabetes who are overweight or obese. Methods: participants (mean age ± SD: 55 ± 6 years; BMI: 31.1 ± 4.1 kg/m²) were randomly assigned to either the treatment group (n = 15) or the control group (n = 15). Both groups received INT and CGM, but the control group was blinded to the CGM data until the end of this study. Participants were followed for 30 days and visited the lab every 10 days for CGM replacement, study measurements, and dietary consultations. Results: the treatment group showed a significant increase in the percentage of time spent in the target blood glucose range (p = 0.02) and a significant decrease in the mean blood glucose concentration (p < 0.05), glucose management indicator (p = 0.02), percent coefficient of variation for blood glucose (p = 0.01), and percent time spent in the high or very high blood glucose ranges (p = 0.04). These changes were not statistically significant for the control group. Conclusions: adding CGM feedback to INT resulted in better management of blood glucose levels in overweight or obese individuals with prediabetes.

Background Nonalcoholic fatty liver disease (NAFLD) is a globally increasing health epidemic. Lifestyle intervention is recommended as the main therapy for NAFLD. However, the optimal approach is still unclear. This study aimed to evaluate the effects of a comprehensive approach of intensive lifestyle intervention (ILI) concerning enhanced control of calorie-restricted diet (CRD), exercise, and personalized nutrition counseling on liver steatosis and extrahepatic metabolic status in Chinese overweight and obese patients with NAFLD. Methods This study was a multicenter randomized controlled trial (RCT) conducted across seven hospitals in China. It involved 226 participants with a body mass index (BMI) above 25. These participants were randomly assigned to two groups: the ILI group, which followed a low carbohydrate, high protein CRD combined with exercise and intensive counseling from a dietitian, and a control group, which adhered to a balanced CRD along with exercise and standard counseling. The main measure of the study was the change in the fat attenuation parameter (FAP) from the start of the study to week 12, analyzed within the per-protocol set. Secondary measures included changes in BMI, liver stiffness measurement (LSM), and the improvement of various metabolic indexes. Additionally, predetermined subgroup analyses of the FAP were conducted based on variables like gender, age, BMI, ethnicity, hyperlipidemia, and hypertension. Results A total of 167 participants completed the whole study. Compared to the control group, ILI participants achieved a significant reduction in FAP (LS mean difference, 16.07 [95% CI: 8.90–23.25] dB/m) and BMI (LS mean difference, 1.46 [95% CI: 1.09–1.82] kg/m 2 ) but not in LSM improvement (LS mean difference, 0.20 [95% CI: -0.19–0.59] kPa). The ILI also substantially improved other secondary outcomes (including ALT, AST, GGT, body fat mass, muscle mass and skeletal muscle mass, triglyceride, fasting blood glucose, fasting insulin, HbA1c, HOMA-IR, HOMA-β, blood pressure, and homocysteine). Further subgroup analyses showed that ILI, rather than control intervention, led to more significant FAP reduction, especially in patients with concurrent hypertension ( p  < 0.001). Conclusion In this RCT, a 12-week intensive lifestyle intervention program led to significant improvements in liver steatosis and other metabolic indicators in overweight and obese Chinese patients suffering from nonalcoholic fatty liver disease. Further research is required to confirm the long-term advantages and practicality of this approach. Trial registration This clinical trial was registered on ClinicalTrials.gov (registration number: NCT03972631) in June 2019.

In the few weight loss studies assessing diet quality, improvements have been minimal and recommended calculation methods have not been used. This secondary analysis of a parallel group randomised trial (regsitered: https://clinicaltrials.gov/ct2/show/NCT03367936) assessed whether self-monitoring with feedback (SM + FB) v. self-monitoring alone (SM) improved diet quality. Adults with overweight/obesity (randomised: SM n 251, SM + FB n 251; analysed SM n 170, SM + FB n 186) self-monitored diet, physical activity and weight. Real-time, personalised feedback, delivered via a study-specific app up to three times daily, was based on reported energy, fat and added sugar intake. Healthy Eating Index 2015 (HEI-2015) scores were calculated from 24-hour recalls. Higher scores represent better diet quality. Data were collected August 2018 to March 2021 and analysed spring 2022. The sample was mostly female (78·9 %) and white (85·4 %). At baseline, HEI-2015 total scores and bootstrapped 95 % CI were similar by treatment group (SM + FB: 63·11 (60·41, 65·24); SM: 61·02 (58·72, 62·81)) with similar minimal improvement observed at 6 months (SM + FB: 65·42 (63·30, 67·20); SM: 63·19 (61·22, 64·97)) and 12 months (SM + FB: 63·94 (61·40, 66·29); SM: 63·56 (60·81, 65·42)). Among those who lost ≥ 5 % of baseline weight, HEI-2015 scores improved (baseline: 62·00 (58·94, 64·12); 6 months: 68·02 (65·41, 71·23); 12 months: 65·93 (63·40, 68·61)). There was no effect of the intervention on diet quality change. Clinically meaningful weight loss was related to diet quality improvement. Feedback may need to incorporate more targeted nutritional content.

Various weight management practices may have different impacts on weight loss at different time points. The aim of this study was to compare the temporal effectiveness of intermittent fasting (IF) versus calorie-restricted diet (CRD), both combined with exercise, for weight management in overweight and obese adults. Ninety-six overweight/obese adults were voluntarily assigned to either a 5:2 IF combined with moderate exercise (IF group, n = 50) or a CRD combined with moderate exercise (CRD group, n = 46). The intervention timeline included a 4-wk weight loss phase, a 4-wk weight maintenance phase, and follow-up assessments at 6 and 12 mo. Changes in body weight, body composition, and cardiometabolic parameters were compared at different time points. After the 4-wk weight loss period, weight loss in the IF and CRD groups was −4.87 ± 2.32 kg and −2.82 ± 1.99 kg, respectively, with a statistically significant difference between groups (P < 0.001). During the 4-wk weight maintenance period, both reduction in body weight and improvements in body composition parameters were observed in both groups (P < 0.05). At 6- and 12-mo follow-ups, participants in both groups regained weight to varying degrees, with more fat mass regain in the CRD group. Our results demonstrate that both IF and CRD, combined with exercise, are effective short-term (4-wk) weight loss strategies. However, long-term follow-ups (6 and 12 mo) revealed that the IF approach may be superior for weight maintenance and show better prevention of weight regain compared with CRD.

Obesity poses a significant public health challenge among middle-aged women, driven by physiological changes associated with aging and menopause. This parallel-group, assessor-blinded, four-arm randomized controlled trial investigated the effects of 12-week 8-hour flexible time-restricted eating (flexTRE) and aerobic exercise (EX), alone or in combination (flexTRE+EX), on body composition and metabolic health in a free-living setting. Participant enrolment began on September 1 st 2023 and data collection was completed on July 1 st 2024. Conducted at a single research site in Hong Kong, the trial enrolled women aged 40–60 years with overweight/obesity. Participants were randomized in a 1:1:1:1 ratio to a flexTRE, EX, flexTRE+EX, or control (CON) group (n = 26 per group), with all 104 participants included in the final intention-to-treat analysis. Outcomes were assessed at baseline, and week 12. The primary outcome was fat mass. The flexTRE+EX group achieved the greatest fat mass reduction compared to the CON group (adjusted mean difference [99% Confidence Interval] −2.85 kg [−4.01 to −1.69]), and additional benefit over the flexTRE group alone (−1.56 kg [−2.74 to −0.38]), and the EX group alone (−2.01 kg [−3.21 to −0.81]). Secondary outcomes were reported in the main text. No serious adverse events were reported, and adherence was high (83%-87%) across intervention groups. These findings suggest that the combined approach effectively reduces fat mass and enhances related metabolic parameters, providing a feasible and effective strategy in middle-aged women facing overweight/obesity. Trial registration: ChiCTR2300074846. Obesity poses a health challenge among middle-aged women in part driven by physiological changes associated with aging and menopause. Here the authors report a randomized controlled trial showing that a combination intervention of flexible time-restricted eating and exercise leads to greater reduction in fat mass than single interventions in women aged 40-60 years.

Obesity stands out as a primary risk factor for diabetes. Attaining healthy weight loss, especially reducing body fat, is important in managing prediabetes and preventing progression to full diabetes and its co-morbidities. This study examined the effects of personalized nutrition therapy (PNT) combined with continuous glucose monitoring (CGM) on body weight and composition in individuals with prediabetes. A total of 30 individuals with prediabetes who were overweight or obese were assigned randomly to either the treatment, observed CGM data plus PNT, or the control group which was blinded to their blood glucose results throughout the study. Both groups were provided with dietary recommendations for calorie intake and macronutrient distribution, coupled with personalized goal setting for glucose control and healthy eating, without any specific emphasis on weight reduction or changes in physical activity. Regular visits were scheduled every 10 days to perform measurements and replace CGMs. Data were analyzed using General Linear Model with repeated measures. Over the 30-day follow-up period, both groups experienced significant reductions in weight and fat mass. The treatment group exhibited two-fold greater reductions in both weight and fat mass, a significant decrease in carbohydrate intake, and a significant increase in time spent on physical activitycompared to the control group. In addition, compliance was notably higher in the treatment group. These findings indicate that overweight or obese individuals with prediabetes can achieve weight loss and improved body composition through personalized education for glucose control, without exclusively emphasizing weight loss as the primary objective. Additionally, the real-time feedback provided by CGM enhances these improvements.