Development and Validation of the Food-Craving Inventory

Objective: The primary aim of this study was to develop and validate the Food-Craving Inventory (FCI), a self-report measure of specific food cravings. Research Methods and Procedures: In a preliminary study, participants (n = 474) completed the initial version of the FCI. The results from this study were used in developing the revised FCI. Participants (n = 379) completed the revised FCI in the primary study designed to develop a self-report measure of specific food cravings. Results: Common factor analysis yielded four conceptual factors (subscales) that were interpreted as high fats, sweets, carbohydrates/starches, and fast-food fats. Confirmatory factor analysis found that the four factors could be modeled as dimensions (or first-order factors) of a higher order construct—food craving. Test–retest and internal consistency analyses indicated good reliability for the total score and each of the subscales. Subscale scores were compared with scores on the Three Factor Eating Questionnaire and a conceptual measure of food craving. We found support for the content, concurrent, construct, and discriminant validity of the FCI. Discussion: The FCI was found to be a reliable and valid measure of general and specific food cravings. The FCI can be used in research related to overeating and binge eating. Also, it may be useful in treatment studies that target obesity and/or food cravings.     

Similarities in Food Cravings and Mood States Between Obese Women and Women Who Smoke Tobacco

The present study assessed food cravings in a cohort of 229 women who differed in smoking history (i.e., never smoker, former smoker, and current smoker) and body weight (i.e., normal weight, overweight, and obese). Each subject completed the Food Craving Inventory (FCI), which measures cravings for sweets, high fats, carbohydrates/starches, and fast‐food fats, and the Profile of Mood States (POMS), which measures psychological distress. Smoking and obesity were independently associated with specific food cravings and mood states. Current smokers craved high fats more frequently than former and never smokers. They also craved starches more frequently and felt more depressed and angry than never smokers, but not former smokers. Whereas cravings for starchy foods and some mood states may be characteristic of women who are likely to smoke, more frequent cravings for fat among smokers is related to smoking per se. Similarly, obese women craved high fats more frequently than nonobese women and depression symptoms were intensified with increasing body weights. We hypothesize that the overlapping neuroendocrine alterations associated with obesity and smoking and the remarkable similarities in food cravings and mood states between women who smoke and women who are obese suggest that common biological mechanisms modulate cravings for fat in these women.     

Changes in obesity-related attitudes in women seeking weight reduction

Objective: To examine changes in obesity‐related attitudes in a sample of obese women who participated in either dieting or non‐dieting interventions. Research Methods and Procedures: A total of 123 obese women were randomly assigned to one of three weight control programs: meal replacement diet, balanced deficit diet, or a non‐dieting program. (The first two groups were combined as a single dieting condition.) Participants completed questionnaires (at baseline, Week 20, and Week 40) to assess beliefs and attitudes about obesity, along with measures of self‐esteem, depression, and body image. Results: At Weeks 20 and 40, participants in the non‐dieting condition reported significantly less negativity about obesity than those in the dieting group. Women in the dieting condition did not report an increase in negative attitudes toward obesity, despite losing significantly more weight than non‐dieting participants. Both groups experienced improvements in self‐esteem, body image, and depressive symptoms. Improvement in self‐esteem was associated with a reduction in negativity about obesity and with improvements in body image. Discussion: The non‐dieting program produced greater reductions in negative attitudes toward obesity than the dieting intervention. Dieting (with successful weight loss), however, did not result in greater negativity toward obesity. Non‐dieting programs seem to be useful in obese women for improving self‐esteem, body image, and internalized negative attitudes about obesity.     

Effect of NPY5R antagonist MK-0557 on weight regain after very-low-calorie diet-induced weight loss

Objective: To evaluate whether MK‐0557, a highly selective, orally administered neuropeptide Y Y5 receptor antagonist, could limit weight regain after very‐low‐calorie diet (VLCD)‐induced weight loss. Research Methods and Procedures: We enrolled 502 patients 18 to 65 years of age with a BMI of 30 to 43 kg/m². Patients were placed on a VLCD (800 kcal/d liquid diet) for 6 weeks. Patients who lost ≥6% of initial body weight (n = 359) were randomized to 52 weeks of 1 mg/d MK‐0557 or placebo and maintained on a hypocaloric diet (300 kcal below weight maintenance requirements). Results: In randomized patients, the VLCD was associated with an average weight loss of 9.1 kg. After 12 weeks of double‐blind treatment, weight began to gradually increase for both placebo‐ and MK‐0557‐treated patients. The mean weight change (95% confidence interval) from baseline at the end of the VLCD to Week 52 was +3.1 (2.1, 4.0) and +1.5 (0.5, 2.4) kg for patients treated with placebo and MK‐0557, respectively. The difference of 1.6 kg between the two groups was significant (p = 0.014). Secondary endpoints, such as blood pressure, lipid profile, insulin, and leptin, as well as waist circumference and quality‐of‐life measurements, did not show significant differences between MK‐0557 and placebo treatments. Discussion: Although the difference in weight regain between placebo‐ and MK‐0557‐treated patients was statistically significant, the magnitude of the effect was small and not clinically meaningful. Antagonism of the neuropeptide Y Y5 receptor is not an efficacious treatment strategy for reducing weight regain after VLCD.     

The evolution of very-low-calorie diets: an update and meta-analysis

Objective: Very‐low‐calorie diets (VLCDs), providing <800 kcal/d, have been used since the 1970s to induce rapid weight loss. Previous reviews of the literature have disagreed concerning the relative efficacy of VLCDs vs. conventional low‐calorie diets (LCDs) for achieving long‐term weight loss. Research Methods and Procedures: We sought to update findings on the clinical use, safety, and efficacy of VLCDs and to perform a meta‐analysis of randomized trials that compared the long‐term efficacy of LCDs and VLCDs. Original research articles were retrieved by a Medline search and from prior reviews of VLCDs. Trials were included only if they were randomized comparisons of LCDs and VLCDs and included a follow‐up assessment at least 1 year after maximum weight loss. Data were abstracted by both authors regarding: duration of VLCD, total length of treatment, attrition, short‐ and long‐term weight loss, changes in weight‐related comorbidities, and adverse effects. Results: Six randomized trials were found that met inclusion criteria. VLCDs, compared with LCDs, induced significantly greater short‐term weight losses (16.1 ± 1.6% vs. 9.7 ± 2.4% of initial weight, respectively; p = 0.0001) but similar long‐term losses (6.3 ± 3.2% vs. 5.0 ± 4.0%, respectively; p > 0.2). Attrition was similar with VLCD and LCD regimens. Discussion: VLCDs did not produce greater long‐term weight losses than LCDs. In the United States, the use of liquid meal replacements as part of a 1000 to 1500 kcal/d diet may provide an effective and less expensive alternative to VLCDs. In Europe, VLCDs are used with less intensive medical supervision than in the United States, which reduces the cost of this approach.     

Effect of calorie restriction on resting metabolic rate and spontaneous physical activity

Objective: It is unclear if resting metabolic rate (RMR) and spontaneous physical activity (SPA) decrease in weight‐reduced non‐obese participants. Additionally, it is unknown if changes in SPA, measured in a respiratory chamber, reflect changes in free‐living physical activity level (PAL). Research Methods and Procedures: Participants (N = 48) were randomized into 4 groups for 6 months: calorie restriction (CR, 25% restriction), CR plus structured exercise (CR+EX, 12.5% restriction plus 12.5% increased energy expenditure via exercise), low‐calorie diet (LCD, 890 kcal/d supplement diet until 15% weight loss, then weight maintenance), and control (weight maintenance). Measurements were collected at baseline, Month 3, and Month 6. Body composition and RMR were measured by DXA and indirect calorimetry, respectively. Two measures of SPA were collected in a respiratory chamber (percent of time active and kcal/d). Free‐living PAL (PAL = total daily energy expenditure by doubly labeled water/RMR) was also measured. Regression equations at baseline were used to adjust RMR for fat‐free mass and SPA (kcal/d) for body weight. Results: Adjusted RMR decreased at Month 3 in the CR group and at Month 6 in the CR+EX and LCD groups. Neither measure of SPA decreased significantly in any group. PAL decreased at Month 3 in the CR and LCD groups, but not in the CR+EX group, who engaged in structured exercise. Changes in SPA in the chamber and free‐living PAL were not related. Discussion: Body weight is defended in non‐obese participants during modest caloric restriction, evidenced by metabolic adaptation of RMR and reduced energy expenditure through physical activity.     

Treatment of Morbid Obesity in Inner‐City Women

Objective: To explore the use of the very‐low‐calorie formula diet (VLCD) in the indigent population of Newark, NJ, with the goal of achieving 10% weight loss within a relatively short period of 10 weeks. Research Methods and Procedures: We accepted 131 morbidly obese indigent women into our study program. The study was limited to women only and the average starting weight was 292.3 ± 5.9 lbs (± SE; 50.3 ± 0.9 body mass index [kg/m²]). We used three treatment paradigms: total cost‐free program for 10 weeks; cost‐free, but compliance requirements; and a weekly charge of $25. The results obtained were compared with two control populations: women enrolled during the same recruitment period in a comparable suburban VLCD program and a historical control population of suburban women treated from 1985 through 1995. Results: In group A (total cost‐free), 79% of patients completed the 10‐week program, but only 18% of patients achieved the goal of 10% weight loss. In group B when attendance and weight loss requirements were imposed, the dropout rate accelerated such that only 37% of patients completed the 10‐week course, and 16% of the women were successful with their weight loss. In group C, imposing $25/wk financial outlay also accelerated dropouts but had little effect on weight loss success, which was 10% of the starting group. By comparison, the suburban patients and the historical control group exhibited 67% and 76% attendance rates after 10 weeks, and 33% and 55% success rates, respectively, in achieving the weight loss goal. Discussion: We conclude that inner‐city patients exhibit great interest in weight loss when financial barriers are removed. Successful weight loss was achieved in 10% to 18% of patients using the VLCD approach, approximately one‐half of that obtained in affluent suburban women. Imposing financial or compliance restrictions to the inner‐city patients served only to enhance dropouts.     

The role of time of food intake on upcoming liver disease in male Wistar rat

Interventions against obesity, are mainly around changing calorie intake and energy expenditure. Recently, some studies focused on the influence of circadian time of food intake on metabolic status. Here, we compare the role of calorie restriction and time restricted feeding followed by high-fat diet started post weaning, First, 52 male Wistarrats (3 weeks old) were divided into two groups: the high-fat diet (HFD, n = 42) and the control group (CON1, n = 11). After 17 weeks, five rats were randomly selected from each group for sample preparation. In the second phase, the animals in HFD group were assigned into four groups (n = 9): (1) 30% calorie restriction (CR), (2) day intermittent fasting (DIF), (3) night intermittent fasting (NIF), (4) adlibitum food intake (AL), (5) remained animal from the first phase control (CON2). Seventeen weeks of HFD started post-weaning did not cause fatty liver but it caused a significant difference in the body and the adipose tissue weight (P0.05). The results showed that longtime HFD did not lead to liver steatosis while the incorrect time of food intake predisposes the animal to the upcoming liver disease. This data indicate a significant role of timing of food intake rather than nutrition composition itself.     

Propranolol,a β-adrenergic antagonist,attenuates the decrease in trabecular bone mass in high calorie diet fed growing mice

We investigated the effects of high calorie and low calorie diets on skeletal integrity, and whether β-adrenergic blockade (BB) attenuates bone loss induced by dietary calorie alteration. Male 6-week-old C57BL/6 mice were assigned to either an ad-lib fed control diet (CON), a high calorie diet (HIGH), or a low calorie diet (LOW) group. In each diet group, mice were treated with either vehicle (VEH) or propranolol, a β-adrenergic antagonist. Over 12-weeks, β-blockade mitigated body weight and fat mass increases induced by the high calorie diet. Femoral trabecular bone mineral density and the expression levels of osteogenic marker genes in bone marrow cells were reduced in HIGHVEH and LOWVEH mice, and BB significantly attenuated this decline only in HIGH mice. In summary, the magnitude of bone loss induced by low calorie diet was greater than that caused by high calorie diet in growing mice, and β-blockade mitigated high calorie diet-induced bone loss. [BMB Reports 2014; 47(9): 506-511]     

Successful long-term weight maintenance: a 2-year follow-up

Objective: To find factors associated with successful weight maintenance (WM) in overweight and obese subjects after a very low‐calorie diet (VLCD). Research Methods and Procedures: Subjects (133) followed a VLCD (2.1 MJ/d) for 6 weeks in a free‐living situation. Of these, 103 subjects (age, 49.6 ± 9.7 years; BMI, 30.9 ± 3.8 kg/m²) completed the following 2‐year WM period. Body weight (BW), body composition, leptin concentration, attitude toward eating, and physical activity were determined right before (t0) and after (t1) the VLCD, after 3 months (t2), after 1 year (t3), after 1.5 years (t4), and after 2 years (t5). Results: BW loss during VLCD was 7.2 ± 3.1 kg. After 2 years, follow‐up BW regain was 69.0 ± 98.4%. After 2 years of WM, 13 subjects were successful (<10% BW regain), and 90 were unsuccessful (>10% BW regain). At baseline, these groups were significantly different in BMI (33.7 ± 4.7 vs. 30.5 ± 3.5 kg/m², respectively; p < 0.05) and fat mass (38.3 ± 9.8 vs. 32.1 ± 8.3 kg, p < 0.05). Successful subjects increased their dietary restraint significantly more during the whole study period (dietary restraint score, ?4.9 ± 4.4 vs. ?2.1 ± 3.8). Furthermore, %BW regain was associated with the amount of percentage body fat lost during VLCD, which indicates that the more fat lost, the better the WM, suggesting a fat free mass‐sparing effect. Discussion: Characteristics such as the ability to increase dietary restraint and maintain this high level of restraint, fat free mass sparing, and a relatively high baseline BMI and fat mass were associated with successful long‐term WM (<10% regain after 2 years).     

Sibutramine plus meal replacement therapy for body weight loss and maintenance in obese patients

Objective: Our objective was to assess the efficacy and safety of sibutramine with a low‐calorie diet (LCD) and commercial meal‐replacement product in achieving weight loss and weight‐loss maintenance in obese patients. Research Methods and Procedures: Eight U.S. centers recruited 148 obese patients for a 3‐month comprehensive weight‐loss therapy (Phase I) comprising daily sibutramine 10 mg + LCD (two Slim‐Fast meal‐replacement shakes, one low‐calorie meal; total kcal/d = 1200–1500). Patients (N = 113) who lost ≥5% of initial body weight during Phase I were randomized for a 9‐month period (Phase II) to daily sibutramine 15 mg + LCD (one meal‐replacement shake; two low‐calorie meals: total kcal/d ～1200–1500) or daily placebo + three low‐calorie meals (total kcal/d ～1200–1500). Both phases included behavior modification. Efficacy was assessed by body weight change during each phase and by the number of patients at endpoint maintaining ≥80% of the weight they had lost by the end of Phase I. Other outcomes included changes in cardiovascular and metabolic risk factors, adverse events, and vital signs. Results: Mean body weight change during Phase I was ?8.3 kg (p < 0.001). Patients randomized to sibutramine in Phase II had an additional ?2.5 kg mean weight loss vs. a 2.8‐kg increase in the placebo group (p < 0.001). More sibutramine patients maintained ≥80% of their Phase I weight loss at the end of Phase II (85.5% vs. placebo 36.7%, p < 0.001). Most adverse events were mild or moderate in severity, and all serious adverse events were unrelated to sibutramine. Discussion: Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients.     

Soluble receptor for advanced glycation end products as a potential biomarker to predict weight loss and improvement of insulin sensitivity by a very low calorie diet of obese human subjects

IntroductionObesity is associated with low-grade systemic inflammation which is thought to trigger the development of comorbidities such as type 2 diabetes. The soluble receptor for advanced glycation end products (sRAGE) belongs to the innate immune system and has been linked to obesity, recently. The aim of the present study was to examine whether serum sRAGE concentrations are related to the grade of weight loss and improvement of insulin resistance due to a very low calorie diet (VLCD).Methods22 severe obese subjects (Median Body Mass Index (BMI): 44.5 kg/m²) were included in a dietary intervention study of 6 month, consisting of a very low calorie formula diet phase (VLCD: 800 kcal/d) for 12 weeks and a following 12 week weight maintenance phase. Fasting glucose, fasting insulin, adiponectin, leptin and sRAGE were determined from sera. Insulin sensitivity was estimated by Homeostasis Model Assessment (HOMA) index and leptin-to-adiponectin-ratio (LAR).ResultsMean body weight reduction by VLCD accounted to 21.7 kg with a significant improvement of insulin resistance. At baseline, sRAGE serum levels were significantly inversely related to BMI (r_S = −0.642, p = 0.001) and HOMA (r_S = −0.419, p = 0.041). Of interest, sRAGE serum levels at baseline were significantly lower in study subjects with greater reduction of BMI (p = 0.017). In addition, a significantly greater HOMA reduction was observed in subjects with lower sRAGE serum levels at baseline (p = 0.006). Finally, correlation analysis revealed, that changes of sRAGE serum levels were significantly correlated to changes of BMI (r_S = −0.650, p = 0.022) during intervention.ConclusionAnti-inflammatory sRAGE might be a potential future biomarker to predict weight loss and improvement of insulin resistance by a VLCD whereby lower baseline sRAGE serum levels indicate a better outcome of the dietary intervention.     

Long-term beneficial effect of a 16-week very low calorie diet on pericardial fat in obese type 2 diabetes mellitus patients

Pericardial fat accumulation has been associated with an increased cardiovascular risk. A very low calorie diet (VLCD) improves the cardiovascular risk profile in patients with type 2 diabetes mellitus (T2DM), by improving the metabolic profile, heart function, and triglyceride (TG) stores in (non)adipose tissues. However, long-term effects of a VLCD on pericardial fat volume and tissue-specific TG accumulation have not been documented. The aim of this study was therefore to assess the effects of a 16-week VLCD and of subsequent 14 months follow-up on a regular diet on pericardial fat in relation to other TG stores in obese T2DM patients. We included 14 obese patients with insulin-treated T2DM (mean ± s.e.m.: age 53 ± 2 years; BMI 35 ± 1 kg/m(2)). Pericardial fat and other (non)adipose TG stores were measured using magnetic resonance (MR) imaging and proton spectroscopy before and after a 16-week VLCD and after a 14-month follow-up without dietary interventions. A 16-week VLCD reduced body weight, pericardial fat, hepatic TG content, visceral and subcutaneous abdominal fat volumes to 78, 83, 16, 40, and 53% of baseline values respectively, (all P < 0.05). After an additional 14 months of follow-up on a regular diet, the reduction in pericardial fat volume sustained, despite a substantial regain in body weight, visceral abdominal fat, and hepatic TG content (respectively 90, 83 and 73% of baseline values). In conclusion, VLCD-induced weight loss in obese T2DM patients is accompanied by a substantial decrease in pericardial fat volume, which is sustained even after subsequent weight regain.     

Reducing Anti‐Fat Prejudice in Preservice Health Students: A Randomized Trial

Anti‐fat sentiment is increasing, is prevalent in health professionals, and has health and social consequences. There is no evidence for effective obesity prejudice reduction techniques in health professionals. The present experiment sought to reduce implicit and explicit anti‐fat prejudice in preservice health students. Health promotion/public health bachelor degree program students (n = 159) were randomized to one of three tutorial conditions. One condition presented an obesity curriculum on the controllable reasons for obesity (i.e., diet/exercise). A prejudice reduction condition presented evidence on the uncontrollable reasons for obesity (i.e., genes/environment); whereas a neutral (control) curriculum focused on alcohol use in young people. Measures of implicit and explicit anti‐fat prejudice, beliefs about obese people, and dieting, were taken at baseline and postintervention. Repeated measures analyses showed decreases in two forms of implicit anti‐fat prejudice (decreases of 27 and 12%) in the genes/environment condition relative to other conditions. The diet/exercise condition showed a 27% increase in one measure of implicit anti‐fat prejudice. Reductions in explicit anti‐fat prejudice were also seen in the genes/environment condition (P = 0.006). No significant changes in beliefs about obese people or dieting control beliefs were found across conditions. The present results show that anti‐fat prejudice can be reduced or exacerbated depending on the causal information provided about obesity. The present results have implications for the training of health professionals, especially given their widespread negativity toward overweight and obesity.     

The Effect of Repeated Episodes of Dietary Restriction and Refeeding on Systolic Blood Pressure and Food Intake in Exercise‐Trained Normotensive Rats

Objective: To explore the effects of weight cycling and exercise on blood pressure and macronutrient intake in Sprague‐Dawley rats. Research Methods and Procedures: Female Sprague‐Dawley rats (n = 62; 5 months old) were assigned to an ad libitum (Con) or weight‐cycled (Cyc) group. They were either sedentary (Con‐Sed and Cyc‐Sed) or exercise‐trained (Con‐Ex and Cyc‐Ex) on a motorized treadmill (20 m/minute; 60 minutes/day; 6 days/week). The Cyc groups underwent 2 cycles of 3 weeks of 60% food restriction followed by 5 weeks of ad libitum refeeding using a macronutrient self‐selection diet. Body mass and food intake were analyzed weekly. Systolic blood pressure (SBP) was measured at baseline and during the first and fifth weeks of each refeeding. Results: For both cycling periods, SBP was elevated in Cyc vs. Con groups at Week 1 of refeeding, but was similar among groups by Week 5 of refeeding. Both Con groups had greater total energy intake than the Cyc groups for both cycling periods (Cycle 1: 2882.2 ± 75.1, Con‐Sed; 2916.1 ± 67.1, Con‐Ex; 2692.2 ± 58.7, Cyc‐Sed; and 2780.5 ± 52.4 kcal, Cyc‐Ex) (Cycle 2: 2815.8 ± 75.1, Con‐Sed; 2938.8 ± 49.4, Con‐Ex; 2577.1 ± 60.5, Cyc‐Sed; and 2643.5 ± 65.9 kcal, Cyc‐Ex). Relative fat intake (percentage of total kcal/week) was significantly less for Con‐Ex and Cyc‐Ex than Con‐Sed and Cyc‐Sed throughout both refeeding periods. Discussion: Weight cycling failed to produce significant sustained effects on SBP, body mass, or food intake. Exercise training, irrespective of diet, lowered dietary fat intake.     

Meal timing and composition influence ghrelin levels, appetite scores and weight loss maintenance in overweight and obese adults

BackgroundAlthough dietary restriction often results in initial weight loss, the majority of obese dieters fail to maintain their reduced weight. Diet-induced weight loss results in compensatory increase of hunger, craving and decreased ghrelin suppression that encourage weight regain. A high protein and carbohydrate breakfast may overcome these compensatory changes and prevent obesity relapse.MethodsIn this study 193 obese (BMI 32.2 ± 1.0 kg/m²), sedentary non diabetic adult men and women (47 ± 7 years) were randomized to a low carbohydrate breakfast (LCb) or an isocaloric diet with high carbohydrate and protein breakfast (HCPb). Anthropometric measures were assessed every 4 weeks. Fasting glucose, insulin, ghrelin, lipids, craving scores and breakfast meal challenge assessing hunger, satiety, insulin and ghrelin responses, were performed at baseline, after a Diet Intervention Period (Week 16) and after a Follow-up Period (Week 32).ResultsAt Week 16, groups exhibited similar weight loss: 15.1 ± 1.9 kg in LCb group vs. 13.5 ± 2.3 kg in HCPb group, p = 0.11. From Week 16 to Week 32, LCb group regained 11.6 ± 2.6 kg, while the HCPb group lost additional 6.9 ± 1.7 kg. Ghrelin levels were reduced after breakfast by 45.2% and 29.5% following the HCPb and LCb, respectively. Satiety was significantly improved and hunger and craving scores significantly reduced in the HCPb group vs. the LCb group.ConclusionA high carbohydrate and protein breakfast may prevent weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression. To achieve long-term weight loss, meal timing and macronutrient composition must counteract these compensatory mechanisms which encourage weight regain after weight loss.     

The effect of caloric restriction interventions on growth hormone secretion in nonobese men and women

Lifespan in rodents is prolonged by caloric restriction (CR) and by mutations affecting the somatotropic axis. It is not known if CR can alter the age‐associated decline in growth hormone (GH), insulin‐like growth factor (IGF)‐1 and GH secretion. To evaluate the effect of CR on GH secretory dynamics; forty‐three young (36.8 ± 1.0 years), overweight (BMI 27.8 ± 0.7) men (n = 20) and women (n = 23) were randomized into four groups; control = 100% of energy requirements; CR = 25% caloric restriction; CR + EX = 12.5% CR + 12.5% increase in energy expenditure by structured exercise; LCD = low calorie diet until 15% weight reduction followed by weight maintenance. At baseline and after 6 months, body composition (DXA), abdominal visceral fat (CT) 11 h GH secretion (blood sampling every 10 min for 11 h; 21:00–08:00 hours) and deconvolution analysis were measured. After 6 months, weight (control: ?1 ± 1%, CR: ?10 ± 1%, CR + EX: ?10 ± 1%, LCD: ?14 ± 1%), fat mass (control: ?2 ± 3%, CR: ?24 ± 3%, CR + EX: ?25 ± 3%, LCD: ?31 ± 2%) and visceral fat (control: ?2 ± 4%, CR: ?28 ± 4%, CR + EX: ?27 ± 3%, LCD: ?36 ± 2%) were significantly (P < 0.001) reduced in the three intervention groups compared to control. Mean 11 h GH concentrations were not changed in CR or control but increased in CR + EX (P < 0.0001) and LCD (P < 0.0001) because of increased secretory burst mass (CR + EX: 34 ± 13%, LCD: 27 ± 22%, P < 0.05) and amplitude (CR + EX: 34 ± 14%, LCD: 30 ± 20%, P < 0.05) but not to changes in secretory burst frequency or GH half‐life. Fasting ghrelin was significantly increased from baseline in all three intervention groups; however, total IGF‐1 concentrations were increased only in CR + EX (10 ± 7%, P < 0.05) and LCD (19 ± 4%, P < 0.001). A 25% CR diet for 6 months does not change GH, GH secretion or IGF‐1 in nonobese men and women.     

A Randomized Trial of Lifestyle Modification and Taranabant for Maintaining Weight Loss Achieved With a Low‐Calorie Diet

Improving the maintenance of weight loss remains a critical challenge for obesity researchers. The present 1‐year, randomized, placebo‐controlled trial evaluated the safety and efficacy of weight maintenance counseling combined with either placebo or the cannabinoid‐1 receptor inverse agonist, taranabant, for sustaining prior weight loss achieved on a low‐calorie diet (LCD). Seven hundred eighty‐four individuals who had lost ≥6% of body weight during six initial weeks of treatment with an 800 kcal/day liquid LCD were randomly assigned to placebo or once‐daily taranabant in doses of 0.5, 1, or 2 mg. All participants were provided monthly, on‐site behavioral weight maintenance counseling, as well as monthly phone calls. The primary end point was change in body weight from randomization to week 52. The randomized participants lost an average of 9.6 kg (9.5% of initial weight) during the 6‐week LCD. The model‐adjusted mean change in body weight during the subsequent 1 year was +1.7 kg for placebo, compared with ?0.1, ?0.6, and ?1.2 kg for the taranabant 0.5, 1, and 2 mg doses, respectively (all P values ≤0.007 vs. placebo). The incidences of psychiatric‐related adverse events, including irritability, were higher for taranabant 1 and 2 mg vs. placebo (P ≤ 0.038). In addition to reporting data on the safety and efficacy of taranabant, this study provides a method for studying the combination of lifestyle modification and pharmacotherapy for weight maintenance after diet‐induced weight loss.