1.
The Obemat2.0 Study: A Clinical Trial of a Motivational Intervention for Childhood Obesity Treatment.
Luque, V, Feliu, A, Escribano, J, Ferré, N, Flores, G, Monné, R, Gutiérrez-Marín, D, Guillen, N, Muñoz-Hernando, J, Zaragoza-Jordana, M, et al
Nutrients. 2019;11(2)
-
-
-
Free full text
Plain language summary
Multicomponent interventions consisting of dietary modification, physical activity, behavioural therapy, and education have shown to improve body mass index, blood pressure, and lipids profile. The Obemat2.0 trail was designed and conducted to implement and to test the efficacy of a structured multicomponent motivational therapy to treat childhood obesity. The study is a randomised clustered clinical trial with a treatment on children with obesity lasting 12 months. The study had two arms: a control group and an intervention group. The recruitment started in June 2016 and the fieldwork is expected to end in June 2019. The study results will show whether a multicomponent program, including a bundle of motivational strategies conducted in primary centres by therapists with 12h of specific training could be more effective than usual care. Authors expect this clinical trial to open a window of opportunity to support professionals at the primary care level to treat childhood obesity.
Abstract
The primary aim of the Obemat2.0 trial was to evaluate the efficacy of a multicomponent motivational program for the treatment of childhood obesity, coordinated between primary care and hospital specialized services, compared to the usual intervention performed in primary care. This was a cluster randomized clinical trial conducted in Spain, with two intervention arms: motivational intervention group vs. usual care group (as control), including 167 participants in each. The motivational intervention consisted of motivational interviewing, educational materials, use of an eHealth physical activity monitor and three group-based sessions. The primary outcome was body mass index (BMI) z score increments before and after the 12 (+3) months of intervention. Secondary outcomes (pre-post intervention) were: adherence to treatment, waist circumference (cm), fat mass index (z score), fat free mass index (z score), total body water (kg), bone mineral density (z score), blood lipids profile, glucose metabolism, and psychosocial problems. Other assessments (pre and post-intervention) were: sociodemographic information, physical activity, sedentary activity, neuropsychological testing, perception of body image, quality of the diet, food frequency consumption and foods available at home. The results of this clinical trial could open a window of opportunity to support professionals at the primary care to treat childhood obesity. The clinicaltrials.gov identifier was NCT02889406.
2.
Effect of Vitamin D Supplementation on Obesity-Induced Insulin Resistance: A Double-Blind, Randomized, Placebo-Controlled Trial.
Cefalo, CMA, Conte, C, Sorice, GP, Moffa, S, Sun, VA, Cinti, F, Salomone, E, Muscogiuri, G, Brocchi, AAG, Pontecorvi, A, et al
Obesity (Silver Spring, Md.). 2018;26(4):651-657
-
-
-
Free full text
-
Plain language summary
Vitamin D concentration has been inversely associated with impaired glucose regulation, insulin resistance and risk of metabolic dysfunction. The aim of the study was to evaluate whether Vitamin D supplementation could improve insulin sensitivity in patients with a high risk of diabetes. The study is a randomised, double-blind, placebo-controlled trial. The participants with obesity were supplemented with Vitamin D or placebo on top of a hypocaloric diet. Results indicate that Vitamin D supplementation combined with weight loss is linked with a significant improvement in insulin sensitivity in vitamin D deficient participants with obesity.
Abstract
OBJECTIVE The aim was to investigate whether vitamin D supplementation, combined with a hypocaloric diet, could have an independent effect on insulin sensitivity in subjects with both overweight and hypovitaminosis D. Changes from baseline in anthropometric parameters, body composition, glucose tolerance, and insulin secretion were considered as secondary outcomes. METHODS Eighteen volunteers who were nondiabetic and vitamin D deficient and had BMI > 25 kg/m2 were randomized (1:1) in a double-blind manner to a hypocaloric diet + either oral cholecalciferol at 25,000 IU/wk or placebo for 3 months. Hyperinsulinemic-euglycemic clamp to measure insulin sensitivity was performed at baseline and after intervention. RESULTS Body weight in both groups decreased significantly (-7.5% in the vitamin D group and -10% in the placebo group; P < 0.05 for both), with no between-group differences. Serum 25-hydroxyvitamin D levels in the vitamin D group increased considerably (from 36.7 ± 13.2 nmol/L to 74.8 ± 18.7 nmol/L; P < 0.001). Insulin sensitivity in the vitamin D group improved (from 4.6 ± 2.0 to 6.9 ± 3.3 mg·kg-1 ·min-1 ; P < 0.001), whereas no changes were observed in the placebo group (from 4.9 ± 1.1 to 5.1 ± 0.3 mg·kg-1 ·min-1 ; P = 0.84). CONCLUSIONS Cholecalciferol supplementation, combined with a weight loss program, significantly improves insulin sensitivity in healthy subjects with obesity and might represent a personalized approach for insulin-resistant subjects with obesity.
3.
L-carnitine ameliorated fasting-induced fatigue, hunger, and metabolic abnormalities in patients with metabolic syndrome: a randomized controlled study.
Zhang, JJ, Wu, ZB, Cai, YJ, Ke, B, Huang, YJ, Qiu, CP, Yang, YB, Shi, LY, Qin, J
Nutrition journal. 2014;13:110
-
-
-
Free full text
Plain language summary
Metabolic syndrome increases the risk of heart disease and diabetes. Modified fasting therapy, such as a very-low-calorie diet is considered an effective way to tackle obesity and metabolic syndrome. When fasting, calorie restriction may cause fatigue and intense hunger, which may tempt individuals to stop fasting. L-Carnitine is an amino acid that transports long-chain fatty acids to mitochondria and helps them be oxidised to produce energy. L-Carnitine intravenous therapy is more bioavailable, better absorbed, and cleared than oral supplementation. This randomised, single-blinded, placebo-controlled pilot study included 30 individuals with metabolic syndrome who were randomly assigned to receive either 4 g/day of intravenous L-carnitine or saline for seven days to evaluate the effect of L-Carnitine on fatigue, hunger, body mass, lipid profile, and other CHD risk factors during a modified fasting period. The L-Carnitine group showed a significant reduction in waist-hip ratio, body mass, serum insulin levels, γ-glutamyltransferase, mental and physical fatigue, fatigue severity, weight loss, and greater reduction in waist circumference, total cholesterol and hunger when compared to the control group. Healthcare professionals can use the results of this study to understand the beneficial effects of L-Carnitine administration during modified fasting therapy in reducing weight, metabolic risk factors, hunger and fatigue. Long-term studies are required to confirm the benefits of L-carnitine.
Abstract
BACKGROUND The present study aimed to determine that whether L-carnitine infusion could ameliorate fasting-induced adverse effects and improve outcomes. METHOD In this 7-day, randomized, single-blind, placebo-controlled, pilot study, 15 metabolic syndrome (MetS) patients (11/4 F/M; age 46.9 ± 9.14 years; body mass index [BMI] 28.2 ± 1.8 kg/m2) were in the L-carnitine group (LC) and 15 (10/5 F/M; age 46.8 ± 10.9 years; BMI 27.1 ± 2.3 kg/m2) were in the control group (CT). All participants underwent a 5-day modified fasting therapy introduced with 2-day moderate calorie restriction. Patients in the LC group received 4 g/day of intravenous L-carnitine, while patients in the CT group were injected with saline. Blood pressure (BP), anthropometric characteristics, markers of liver function, metabolic indices (plasma glucose, lipid profiles, uric acid, free fatty acid and insulin) and hypersensitivity C-reactive protein were measured. Perceived hunger was recorded daily by self-rating visual analogue scales. Fatigue was evaluated by Wessely and Powell scores. RESULTS In contrast to the CT group, total cholesterol, alanine aminotransferase, systolic and diastolic BP did not change significantly in the LC group after prolonged fasting. There were significant differences in weight loss (LC -4.6 ± 0.9 vs. CT -3.2 ± 1.1 kg, P = 0.03), and waist circumference (LC -5.0 ± 2.2 vs. CT -1.7 ± 1.16 cm, P < 0.001), waist hip ratio (LC -0.023 ± 0.017 vs. CT 0.012 ± 0.01, P < 0.001), insulin concentration (LC -9.9 ± 3.58 vs. CT -6.32 ± 3.44 µU/mL, P = 0.046), and γ-glutamyltransferase concentration (LC -7.07 ± 6.82 vs. CT -2.07 ± 4.18, P = 0.024). Perceived hunger scores were significantly increased (P < 0.05) in the CT group during starvation, which was alleviated with L-carnitine administration in the LC group. Physical fatigue (LC -3.2 ± 3.17 vs. CT 1.8 ± 2.04, P < 0.001) and fatigue severity (LC -11.6 ± 8.38 vs. CT 8.18 ± 7.32, P < 0.001) were significantly reduced in the LC group but were aggravated in the CT group. CONCLUSION Intravenous L-carnitine can ameliorate fasting-induced hunger, fatigue, cholesterol abnormalities and hepatic metabolic changes and facilitate fasting-induced weight loss in MetS patients. TRIAL REGISTRATION ChiCTR-TNRC-12002835.