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3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.
le Roux, CW, Astrup, A, Fujioka, K, Greenway, F, Lau, DCW, Van Gaal, L, Ortiz, RV, Wilding, JPH, Skjøth, TV, Manning, LS, et al
Lancet (London, England). 2017;(10077):1399-1409
Abstract
BACKGROUND Liraglutide 3·0 mg was shown to reduce bodyweight and improve glucose metabolism after the 56-week period of this trial, one of four trials in the SCALE programme. In the 3-year assessment of the SCALE Obesity and Prediabetes trial we aimed to evaluate the proportion of individuals with prediabetes who were diagnosed with type 2 diabetes. METHODS In this randomised, double-blind, placebo-controlled trial, adults with prediabetes and a body-mass index of at least 30 kg/m2, or at least 27 kg/m2 with comorbidities, were randomised 2:1, using a telephone or web-based system, to once-daily subcutaneous liraglutide 3·0 mg or matched placebo, as an adjunct to a reduced-calorie diet and increased physical activity. Time to diabetes onset by 160 weeks was the primary outcome, evaluated in all randomised treated individuals with at least one post-baseline assessment. The trial was conducted at 191 clinical research sites in 27 countries and is registered with ClinicalTrials.gov, number NCT01272219. FINDINGS The study ran between June 1, 2011, and March 2, 2015. We randomly assigned 2254 patients to receive liraglutide (n=1505) or placebo (n=749). 1128 (50%) participants completed the study up to week 160, after withdrawal of 714 (47%) participants in the liraglutide group and 412 (55%) participants in the placebo group. By week 160, 26 (2%) of 1472 individuals in the liraglutide group versus 46 (6%) of 738 in the placebo group were diagnosed with diabetes while on treatment. The mean time from randomisation to diagnosis was 99 (SD 47) weeks for the 26 individuals in the liraglutide group versus 87 (47) weeks for the 46 individuals in the placebo group. Taking the different diagnosis frequencies between the treatment groups into account, the time to onset of diabetes over 160 weeks among all randomised individuals was 2·7 times longer with liraglutide than with placebo (95% CI 1·9 to 3·9, p<0·0001), corresponding with a hazard ratio of 0·21 (95% CI 0·13-0·34). Liraglutide induced greater weight loss than placebo at week 160 (-6·1 [SD 7·3] vs -1·9% [6·3]; estimated treatment difference -4·3%, 95% CI -4·9 to -3·7, p<0·0001). Serious adverse events were reported by 227 (15%) of 1501 randomised treated individuals in the liraglutide group versus 96 (13%) of 747 individuals in the placebo group. INTERPRETATION In this trial, we provide results for 3 years of treatment, with the limitation that withdrawn individuals were not followed up after discontinuation. Liraglutide 3·0 mg might provide health benefits in terms of reduced risk of diabetes in individuals with obesity and prediabetes. FUNDING Novo Nordisk, Denmark.
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Starches, sugars and obesity.
Aller, EE, Abete, I, Astrup, A, Martinez, JA, van Baak, MA
Nutrients. 2011;(3):341-69
Abstract
The rising prevalence of obesity, not only in adults but also in children and adolescents, is one of the most important public health problems in developed and developing countries. As one possible way to tackle obesity, a great interest has been stimulated in understanding the relationship between different types of dietary carbohydrate and appetite regulation, body weight and body composition. The present article reviews the conclusions from recent reviews and meta-analyses on the effects of different starches and sugars on body weight management and metabolic disturbances, and provides an update of the most recent studies on this topic. From the literature reviewed in this paper, potential beneficial effects of intake of starchy foods, especially those containing slowly-digestible and resistant starches, and potential detrimental effects of high intakes of fructose become apparent. This supports the intake of whole grains, legumes and vegetables, which contain more appropriate sources of carbohydrates associated with reduced risk of cardiovascular and other chronic diseases, rather than foods rich in sugars, especially in the form of sugar-sweetened beverages.
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Impact of the menstrual cycle on determinants of energy balance: a putative role in weight loss attempts.
Davidsen, L, Vistisen, B, Astrup, A
International journal of obesity (2005). 2007;(12):1777-85
Abstract
Women's weight and body composition is significantly influenced by the female sex-steroid hormones. Levels of these hormones fluctuate in a defined manner throughout the menstrual cycle and interact to modulate energy homeostasis. This paper reviews the scientific literature on the relationship between hormonal changes across the menstrual cycle and components of energy balance, with the aim of clarifying whether this influences weight loss in women. In the luteal phase of the menstrual cycle it appears that women's energy intake and energy expenditure are increased and they experience more frequent cravings for foods, particularly those high in carbohydrate and fat, than during the follicular phase. This suggests that the potential of the underlying physiology related to each phase of the menstrual cycle may be worth considering as an element in strategies to optimize weight loss. Studies are needed to assess the weight loss outcome of tailoring dietary recommendations and the degree of energy restriction to each menstrual phase throughout a weight management program, taking these preliminary findings into account.
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How to maintain a healthy body weight.
Astrup, A
International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition. 2006;(4):208-15
Abstract
The epidemic of both obesity and type 2 diabetes is due to environmental factors, but the individuals developing the conditions possess a strong genetic predisposition. Observational surveys and intervention studies have shown that excess body fatness is the major environmental cause of type 2 diabetes, and that even a minor weight loss can prevent its development in high-risk subjects. Maintenance of a healthy body weight in susceptible individuals requires 45-60 minutes physical activity daily, a fat-reduced diet with plenty of fruit, vegetables, whole grain, and lean meat and dairy products, and moderate consumption of calorie containing beverages. The use of table values to predict the glycemic index of meals is of little--if any--value, and the role of a low-glycemic index diet for body weight control is controversial. The replacement of starchy carbohydrates with protein from lean meat and lean dairy products enhances satiety, and facilitate weight control. It is possible that dairy calcium also promotes weight loss, although the mechanism of action remains unclear. A weight loss of 5-10% can be induced in almost all obese patients providing treatment is offered by a professional team consisting of a physician and dietitians or nurses trained to focus on weight loss and maintenance. Whereas increasing daily physical activity and regular exercise does not significantly effect the rate of weight loss in the induction phase, it plays an important role in the weight maintenance phase due to an impact on daily energy expenditure and also to a direct enhancement of insulin sensitivity.
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Calcium supplementation for 1 y does not reduce body weight or fat mass in young girls.
Lorenzen, JK, Mølgaard, C, Michaelsen, KF, Astrup, A
The American journal of clinical nutrition. 2006;(1):18-23
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Abstract
BACKGROUND Accumulating evidence from observational studies indicates that a high calcium intake may reduce body weight and body fat. However, few randomized trials have been conducted. OBJECTIVE We examined whether calcium supplementation affects body weight and body fat in young girls and whether a relation exists between habitual calcium intake and body weight and body fat. DESIGN A randomized, double-blind, placebo-controlled intervention study was conducted in 110 young girls. The subjects were randomly assigned to receive 500 mg Ca/d as calcium carbonate or placebo for 1 y. Two groups of girls were selected according to habitual calcium intake from a large group; one group consumed 1000-1304 mg/d (40th-60th percentile; n = 60) and the other group consumed <713 mg/d (<20th percentile; n = 50). Height, body weight, body fat, and calcium intake were measured at baseline and after 1 y. RESULTS At baseline a significant negative correlation was observed between habitual dietary calcium intake and percentage of body fat (r = -0.242, P = 0.011). However, calcium supplementation had no effect on height, body weight, or percentage body fat. CONCLUSIONS Habitual dietary calcium intake was inversely associated with body fat, but a low-dose calcium supplement had no effect on body weight, height, or body fat over 1 y in young girls. It is possible that the effect of calcium on body weight is only exerted if it is ingested as part of a meal, or the effect may be due to other ingredients in dairy products, and calcium may simply be a marker for a high dairy intake.
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No difference in body weight decrease between a low-glycemic-index and a high-glycemic-index diet but reduced LDL cholesterol after 10-wk ad libitum intake of the low-glycemic-index diet.
Sloth, B, Krog-Mikkelsen, I, Flint, A, Tetens, I, Björck, I, Vinoy, S, Elmståhl, H, Astrup, A, Lang, V, Raben, A
The American journal of clinical nutrition. 2004;(2):337-47
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BACKGROUND The role of glycemic index (GI) in appetite and body-weight regulation is still not clear. OBJECTIVE The objective of the study was to investigate the long-term effects of a low-fat, high-carbohydrate diet with either low glycemic index (LGI) or high glycemic index (HGI) on ad libitum energy intake, body weight, and composition, as well as on risk factors for type 2 diabetes and ischemic heart disease in overweight healthy subjects. DESIGN The study was a 10-wk parallel, randomized, intervention trial with 2 matched groups. The LGI or HGI test foods, given as replacements for the subjects' usual carbohydrate-rich foods, were equal in total energy, energy density, dietary fiber, and macronutrient composition. Subjects were 45 (LGI diet: n = 23; HGI diet: n = 22) healthy overweight [body mass index (in kg/m(2)): 27.6 +/- 0.2] women aged 20-40 y. RESULTS Energy intake, mean (+/- SEM) body weight (LGI diet: -1.9 +/- 0.5 kg; HGI diet: -1.3 +/- 0.3 kg), and fat mass (LGI diet: -1.0 +/- 0.4 kg; HGI diet: -0.4 +/- 0.3 kg) decreased over time, but the differences between groups were not significant. No significant differences were observed between groups in fasting serum insulin, homeostasis model assessment for relative insulin resistance, homeostasis model assessment for beta cell function, triacylglycerol, nonesterified fatty acids, or HDL cholesterol. However, a 10% decrease in LDL cholesterol (P < 0.05) and a tendency to a larger decrease in total cholesterol (P = 0.06) were observed with consumption of the LGI diet as compared with the HGI diet. CONCLUSIONS This study does not support the contention that low-fat LGI diets are more beneficial than HGI diets with regard to appetite or body-weight regulation as evaluated over 10 wk. However, it confirms previous findings of a beneficial effect of LGI diets on risk factors for ischemic heart disease.
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How does the body deal with energy from alcohol?
Buemann, B, Astrup, A
Nutrition (Burbank, Los Angeles County, Calif.). 2001;(7-8):638-41
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Randomized controlled trial of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates on body weight and blood lipids: the CARMEN study. The Carbohydrate Ratio Management in European National diets.
Saris, WH, Astrup, A, Prentice, AM, Zunft, HJ, Formiguera, X, Verboeket-van de Venne, WP, Raben, A, Poppitt, SD, Seppelt, B, Johnston, S, et al
International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity. 2000;(10):1310-8
Abstract
OBJECTIVE To investigate the long-term effects of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates. DESIGN Randomized controlled multicentre trial (CARMEN), in which subjects were allocated for 6 months either to a seasonal control group (no intervention) or to one of three experimental groups: a control diet group (dietary intervention typical of the average national intake); a low-fat high simple carbohydrate group; or a low-fat high complex carbohydrate group. SUBJECTS Three hundred and ninety eight moderately obese adults. MEASUREMENTS The change in body weight was the primary outcome; changes in body composition and blood lipids were secondary outcomes. RESULTS Body weight loss in the low-fat high simple carbohydrate and low-fat high complex carbohydrate groups was 0.9 kg (P < 0.05) and 1.8 kg (P < 0.001), while the control diet and seasonal control groups gained weight (0.8 and 0.1 kg, NS). Fat mass changed by -1.3kg (P< 0.01), -1.8kg (P< 0.001) and +0.6kg (NS) in the low-fat high simple carbohydrate, low-fat high complex carbohydrate and control diet groups, respectively. Changes in blood lipids did not differ significantly between the dietary treatment groups. CONCLUSION Our findings suggest that reduction of fat intake results in a modest but significant reduction in body weight and body fatness. The concomitant increase in either simple or complex carbohydrates did not indicate significant differences in weight change. No adverse effects on blood lipids were observed. These findings underline the importance of this dietary change and its potential impact on the public health implications of obesity.