The Short-term Effects of Fasting on the Neuroendocrine System in Patients with Chronic Pain Syndromes

Abstract

It is commonly reported that short term fasting leads to mood enhancement and emotional harmonisation. We investigated psychosocial well-being and the neuroendocrine response, assessed by nightly urinary excretion of cortisol and catecholamines, in 28 inpatients with chronic pain syndromes during and after a one-week modified fast. Twenty-two of the patients (51.4±2.7 years, BMI 26.8±1.0 kg/m²) participated in a 7-day fast with daily intake of 300 kcal/day, six control patients (47.5±4.0 years; BMI 22.9±1.1 kg/m²) received a vegetarian-based diet. With fasting significant increases of the urinary concentration of noradrenaline (17.8±3.0-27.8±3.8 μg/ml), adrenaline (1.5±0.2-3.4±0.7 μg/ml) and cortisol (26.1±3.7-40.7±6.1 μg/ml) were observed, whereas controls showed no significant endocrine changes. The neuroendocrine response to fasting was pronounced in younger subjects (age <50 years) and in the presence of a BMI >25 kg/m², moreover the increase in cortisol excretion was significantly higher in subjects with lower baseline cortisol levels. Mood and well-being increased non-significantly in both groups. Fasting was well tolerated, and regarded as beneficial by most fasting patients. Our results show that short-term fasting leads to neuroendocrine activation and may suggest that the extent of this response is dependent on the individual metabolic and endocrine state at baseline.     

Prolonged fasting in patients with chronic pain syndromes leads to late mood-enhancement not related to weight loss and fasting-induced leptin depletion

Periods of fasting are practiced worldwide on a cultural/religious background, and related mood-enhancing effects are postulated. We aimed to assess the effect of fasting on mood and to explore the interaction with neuroendocrine activation and leptin depletion in a controlled explorative study on consecutive inpatients (BMI < 35 kg/m2) of a nutritional ward. 36 subjects (38.9 +/- 7.0 years; 29 female, BMI 26.7 +/- 4.1 kg/m2) participated in an 8-day modified fast (300 kcal/day), 19 patients (38.1 +/- 5.9 years; 18 female, 23.5 +/- 4.1 kg/m2) received a mild low calorie diet. Measurements included daily ratings of mood (VAS), weight and levels of leptin and cortisol at four time-points of the 2-week study period. Weight loss was 4.8 +/- 1.2 and 1.6 +/- 0.9 kg in fasters and controls, respectively. Fasters showed a more pronounced decrease of leptin (58% vs. 20%; P < 0.001) and a 17% increase of cortisol levels (P < 0.001). Mood ratings increased significantly in the late phase of fasting (P < 0.01) but were not related to weight-loss, leptin-depletion or cortisol increase. Our findings suggest that fasting induces specific mood-enhancement. The physiological mediator appears to be neither leptin nor cortisol, the role of other mechanisms has to be further studied.     

Leptin,adiponectin, and short-term and long-term weight loss after a lifestyle intervention in obese children

ObjectiveIn overweight children, high leptin levels are independently associated with higher risk for cardiovascular disease, whereas adiponectin seems to be protective against type 2 diabetes and atherosclerosis. The study examines the predictive value of leptin for weight loss after a 4- to 6-wk inpatient therapy and again after 1 y; as well as the association among weight loss, leptin, and adiponectin levels and changes in cardiometabolic risk factors after therapy.MethodsBody mass index (BMI), blood pressure, Tanner stage, and cardiometabolic risk factors were studied in 402 children (59.2% females, 13.9 ± 2.3 y, BMI 33.8 ± 5.7 kg/m²) before and after a 4-to 6-wk inpatient intervention (exercise, diet, and behavioral therapy) and BMI 1 y later (n = 206).ResultsBMI was reduced from 33.8 ± 5.7 to 30.5 ± 5.1 kg/m² (P < 0.001) during the lifestyle intervention and remained unchanged after 1 y. Baseline BMI was positively associated with leptin (r = 0.60; P < 0.001) and cardiometabolic risk factors (blood pressure, high-density lipoprotein [HDL] cholesterol, triglycerides). Baseline leptin was associated with BMI and triglycerides (r = 0.39; P < 0.001), baseline adiponectin with HDL-cholesterol (r = 0.40; P < 0.001). Baseline BMI explained 40.7% of the variance in weight loss during therapy. The combination of BMI, sex, and leptin explained 50.4% of the variance. Neither BMI nor leptin predicted weight changes over the long term.ConclusionsOverweight children maintained a substantial amount of weight loss after participation in a short-term inpatient lifestyle intervention. Baseline BMI was positively associated with weight reduction during the intervention, whereas baseline leptin had only a minor predictive value.     

Serum leptin level in obese women with polycystic ovary syndrome,and its relation to insulin resistance

ObjectiveTo compare serum leptin levels in obese women with polycystic ovary syndrome (PCOS) and normal ovulatory obese subjects in Saudi Arabia, and to evaluate the interrelationship between leptin concentration, sex hormones, and insulin resistance.MethodsThe present study was conducted on 40 women with PCOS (34.30 ± 2.08 years, body mass index (BMI) 34.84 ± 4.77 kg/m², mean ± SD) and 16 obese women as control group (28.10 ± 4.61 years, BMI 33.59 ± 1.23 kg/m²). Diagnostic criteria for PCOS based on the presence of two out of three traits including oligo –and/or anovulation, clinical and/or biochemical signs of hyperandrogenism and the presence of polycystic ovaries on ultrasound scan. Concentrations of testosterone, progesterone, prolactin, gonadotrophins, glucose, insulin, and leptin were measured in the baseline fasting blood sample. Serum leptin concentrations were measured by enzyme linked immunosorbant assay.ResultsSerum leptin levels in PCOS patients were significantly higher than that in the control group (P=0.005) independently of BMI, and were significantly different between insulin resistant and non-insulin resistant obese PCOS (P=0.044), In PCOS patients there was a positive correlation between leptin and BMI (P=0.049), and there was no correlation between leptin and other hormonal indices in PCOS patients.ConclusionsThe study revealed that the body mass index and insulin resistance are the two main factors governing serum leptin levels.     

Effects of orthodox religious fasting versus combined energy and time restricted eating on body weight,lipid concentrations and glycaemic profile

Abstract

For seven weeks, 37 overweight adults followed a hypocaloric diet based on Orthodox Fasting (OF). A hypocaloric, time restricted eating (TRE) plan (eating between 08:00 to 16:00?h, water fasting from 16:00 to 08:00?h) was followed by 23 Body Mass Index (BMI)-matched participants. Anthropometric, glycaemic and inflammation markers and serum lipids were assessed before and after the diets. Both OF and TRE groups demonstrated reductions in BMI (28.54?±?5.45 vs 27.20?±?5.10?kg/m², p?<?0.001 and 26.40?±?4.11 vs 25.81?±?3.78?kg/m² p?=?0.001, respectively). Following the intervention, the OF group presented lower concentrations of total and low-density lipoprotein-cholesterol, compared with the pre-fasting values (178.40?±?34.14 vs 197.17?±?34.30?mg/dl, p?<?0.001 and 105.89?±?28.08 vs 122.37?±?29.70?mg/dl, p?<?0.001, respectively). Neither group manifested significant differences in glycaemic and inflammatory parameters. Our findings suggest that OF has superior lipid lowering effects than the TRE pattern.     

G allele at RAGE SNP82 is associated with proinflammatory markers in obese subjects

Obesity is closely associated with low-grade inflammation. The Gly82Ser (G82S) polymorphism in the receptor for the advanced glycation end products (RAGE) gene related to RAGE expression is also involved in inflammatory response. We examined the association between RAGEG82S and obesity on soluble RAGE (sRAGE) and inflammatory markers in Korean men. The following were measured: anthropometric and biochemical parameters, RAGEG82S polymorphism, sRAGE, advanced glycation end products (AGEs), and inflammatory markers in men (n = 1252; range, 30-70 years; body mass index [BMI], ≥18.5 kg/m²). Allele frequencies satisfied Hardy-Weinberg Equilibrium (G/G: 72.2%, G/S: 25.5%, S/S: 2.3%). RAGEG82S (β-coefficient = ?0.384, P < .001) and BMI (β-coefficient = ?0.168, P = .001) were major factors affecting sRAGE concentrations. In all subjects, those with ‘S/S’ homozygotes showed the lowest levels of sRAGE (G/G: 1036.3 ± 40.3, G/S: 807.0 ± 49.6, S/S: 443.0 ± 47.8 pg/mL) before (P < .001) and after adjusted for age, BMI, cigarette smoking, and alcohol drinking (P < .001). When subdivided according to BMI of 25 kg/m² (Asian Pacific guideline), obese subjects (BMI ≥25 kg/m²) had significantly lower levels of sRAGE (831.7 ± 36.7 vs 1022.7 ± 47.8 pg/mL, P = .009) and higher levels of high sensitivity C-reactive protein (hs-CRP) (1.10 ± 0.07 vs 0.72 ± 0.05 mg/dL, P < .001) compared with nonobese subjects (BMI <25 kg/m²). Particularly in obese subjects, S/S carriers showed significantly higher concentrations of AGEs (P = .012) and hs-CRP (P = .006) than G allele carriers, whereas nonobese people had no significant RAGEG82S-related differences in AGEs (P = .743) and hs-CRP (P = .436). In conclusion, G allele at RAGEG82S may be more associated with inflammatory markers under obese status than nonobese conditions. In this case, it may help to suggest proper dietary modification for controlling obesity to people with genetic variants.     

Randomized Trial Testing the Effects of Eating Frequency on Two Hormonal Biomarkers of Metabolism and Energy Balance

Background: Eating frequency (EF) may influence obesity-related disease risk by attenuating postprandial fluctuations in hormones involved in metabolism, appetite regulation, and inflammation. Materials/methods: This randomized crossover intervention trial tested the effects of EF on fasting plasma insulin-like growth factor-I (IGF-1) and leptin. Fifteen subjects (4 males, 11 females) completed two eucaloric intervention phases lasting 21 days each: low EF (“low-EF”; 3 eating occasions/day) and high EF (“high-EF”; 8 eating occasions/day). Subjects were free-living and consumed their own meals using individualized structured meal plans with instruction from study staff. Subjects completed fasting blood draws and anthropometry on the first and last day of each study phase. The generalized estimated equations modification of linear regression tested the intervention effect on fasting serum IGF-1 and leptin. Results: Mean (± SD) age was 28.5 ± 8.70 years, and mean (± SD) Body Mass Index was 23.3 (3.4) kg/m². We found lower mean serum IGF-1 following the high-EF condition compared to the low-EF condition (P < 0.001). There was no association between EF and plasma leptin (P = 0.83). Conclusion: These results suggest that increased EF may lower serum IGF-1, which is a hormonal biomarker linked to increased risk of breast, prostate, and colorectal cancer.     

Favorable Effect of Short-Term Lifestyle Intervention on Human Paraoxonase-1 Activity and Adipokine Levels in Childhood Obesity

Objective: The prevalence of obesity is increasing in adult and child populations throughout the world. Childhood obesity has a great impact on adult cardiovascular morbidity and mortality; treatment of this pathological state is important given the significant health consequences. We investigated the effect of short-term lifestyle changes on the alteration of human serum paraoxonase-1 (PON1) activities, leptin, adiponectin, E-selectin, and asymmetric dimethylarginine (ADMA) as atherogenic and antiatherogenic factors in obese children. PON1 protects lipoproteins against oxidation by hydrolyzing lipid peroxides in oxidized low density lipoprotein (LDL) and therefore may protect against atherosclerosis.

Methods: A total of 23 white obese and overweight children (age, 11.43 ± 1.78 years; 8 girls, 15 boys) participated in a 2-week-long lifestyle camp based on a diet and exercise program. Overweight and obesity were defined according to the national body mass index (BMI) reference tables for age and sex.

Results: After a 2-week-long supervised diet and aerobic exercise program, obese children had significantly lower leptin (55.02 ± 33.42 ng/ml vs 25.37 ± 19.07 ng/ml; p < 0.0001), ADMA (0.68 ± 0.15 μmol/l vs 0.55 ± 0.16 μmol/l; p < 0.01), and E-selectin levels (67.19 ± 30.35 ng/ml vs 46.51 ± 18.40 ng/ml; p < 0.0001), whereas they had significantly higher PON1 paraoxonase activity (110.48 ± 72.92 U/l vs 121.75 ± 93.48 U/l; p < 0.05) besides the antiatherogenic alteration of the lipid profile and significant weight change (70.32 ± 19.51 kg vs 67.01 ± 18.75 kg, p < 0.0001; BMI, 28.95 ± 5.05 kg/m² vs 27.43 ± 4.82 kg/m², p < 0.0001). Adiponectin and PON1 arylesterase activity did not change significantly.

Conclusions: Our investigation suggests that modifications in dietary habits and physical activity induce antiatherogenic changes in childhood obesity. These findings emphasize the major role of primary prevention and nonpharmaceutical treatment of childhood obesity through lifestyle changes based on diet and increased physical activity.     

Leisure-time physical activity does not fully explain the higher body mass index in irregular-shift workers

Purpose

To elucidate the influence of leisure-time physical activity on body mass index (BMI), appetite-related hormones, and sleep when working irregular shifts.

Methods

A cross-sectional study was undertaken of 57 male truck drivers, 31 irregular-shift workers and 26 day-shift workers. Participants completed the International Physical Activity Questionnaire and were assessed for BMI. Subjects also provided a fasting blood sample for analysis of appetite-related hormones and wore an actigraphy device for seven consecutive days.

Results

Although leisure-time physical activity (LTPA) was generally low (<150 min/week) in both groups, the irregular-shift workers were more physically active than day-shift workers (99 ± 166 vs. 23 ± 76 min/week, p < 0.01). In spite of this, mean BMI of irregular-shift workers was 2 kg/m² greater than day-shift workers (28.4 ± 3.8 vs. 26.4 ± 3.6 kg/m², p = 0.04). Mean leptin concentration was 61 % higher in irregular-shift workers (5,205 ± 4,181 vs. 3,179 ± 2,413 pg/ml, p = 0.04). Among obese individuals, irregular-shift workers had higher leptin concentration (p < 0.01) and shorter sleep duration (p = 0.01) than obese day-shift workers.

Conclusion

Elevated BMI was associated with high leptin and low ghrelin levels in this population of irregular-shift workers. No influence of LTPA on appetite-related hormones or sleep duration was found. We conclude that moderate LTPA is insufficient to attenuate the higher BMI associated with this type of irregular-shift work in truck drivers.     

Prognostic Role of Body Mass Index in Advanced Small Bowel Adenocarcinoma Patients Receiving Palliative Chemotherapy

As small bowel adenocarcinoma (SBA) is a rare cancer worldwide, prognostic factors have not been clearly defined. The purpose of this study is to assess the prognostic role of clinicopathologic features, including body mass index (BMI), in patients with advanced SBA. A total of 28 consecutive patients with advanced SBA treated with palliative chemotherapy were retrospectively enrolled and analyzed. Clinicopathologic features, progression-free survival (PFS), and overall survival (OS) were compared according to BMI level. Eighteen patients had BMI < 25 kg/m² (overweight/normal/underweight in Asian) and ten patients had BMI ≥ 25 kg/m² (obese in Asian). Baseline characteristics were similar regardless of patient's BMI. Compared to patients with BMI < 25 kg/m², patients with BMI ≥ 25 kg/m² had higher response rate to chemotherapy (40.0% vs. 0%, P = 0.010), longer OS (11.2 vs. 7.0 months, P = 0.018) and a tendency toward prolonged PFS (2.1 vs. 1.9 months, P = 0.085). Multivariate analysis revealed that BMI ≥ 25 kg/m² is an independent positive prognostic factor of OS (adjusted hazard ratio 0.35, P = 0.024). In conclusion, baseline BMI ≥ 25 kg/m² has a positive prognostic role in patients with advanced SBA.     

Effects of seafood consumption and weight loss on fasting leptin and ghrelin concentrations in overweight and obese European young adults

Background  Energy restriction affects circulating leptin and ghrelin concentrations. The aim of this study  To investigate whether seafood consumption affects fasting leptin and ghrelin concentrations in addition to weight loss. Methods  In this 8-week dietary intervention, subjects (324 Icelandic, Spanish and Irish subjects, 20–40 years, BMI 27.5–32.5 kg/m²) were randomized to energy-restricted diets (−30%) of identical macronutrient composition but different amount of seafood: control (no seafood); lean fish (150 g cod, three times per week); fatty fish (150 g salmon, three times per week); EPA&DHA [daily docosahexaenoic (DHA)/eicosapentaenoic acid (EPA) capsules]. Anthropometric data, ghrelin, leptin, and insulin were measured at baseline and endpoint. Linear models investigated the effects of seafood on fasting leptin, ghrelin and insulin. Results  Body weight (−5.2 ± 3.0 kg), leptin (−34.8%) and insulin (−13.5%) decreased, while ghrelin increased (5.6%) (all P < 0.001). According to linear models endpoint insulin was significantly lower in the EPA&DHA group (−16.4%, P = 0.025) compared to control, endpoint leptin in men was lower in the salmon group (−22.9%, P = 0.026), and the EPA&DHA group tended to have higher endpoint ghrelin (5.6%, P = 0.060), an effect seen only in women indicated by a significant gender × EPA&DHA interaction. Weight loss explained the effects of fatty seafood on leptin and ghrelin, but not insulin. Conclusions  Consumption of fatty seafood can modulate fasting insulin, ghrelin and leptin during an 8-week intervention. Effects are partly gender specific and are partly explained by weight loss. Consumption of lean fish does not affect circulating hormones in comparison to control. The most consistent effect on circulating hormones is mediated by weight loss.     

Serum leptin and total dietary energy intake: the INTERLIPID Study

Purpose

It has been hypothesized that leptin-induced appetite suppression is impaired in obese individuals, but little human evidence is available documenting this. We investigated relations between serum leptin and total energy intake using INTERLIPID/INTERMAP data on Japanese–Americans in Hawaii and Japanese in Japan.

Methods

Serum leptin and nutrient intakes were examined by standardized methods in men and women aged 40–59 years from two population samples, one Japanese–American in Hawaii (88 men, 94 women), the other Japanese in central Japan (123 men, 111 women). Multiple linear regression analyses stratified by BMI category (<25 kg/m², 25–29.9 kg/m², and ≥30 kg/m²) with adjustment for possible confounders were used to examine the relation between log-leptin and total dietary energy intake.

Results

In multivariate regression analyses, in those with BMI < 25 kg/m² and in those with BMI between 25 and 29.9 kg/m², log-leptin was not significantly related to total dietary energy intake; in those with BMI ≥ 30 kg/m², it was significantly inversely related to total dietary energy intake (P = 0.029), independent of body weight and physical activity. Physical activity score was significantly positively related to total dietary energy intake only in participants with BMI < 25 kg/m² (P < 0.001).

Conclusion

Leptin was significantly inversely associated with dietary energy intake in obese persons, but not in overweight and normal-weight persons.     

Prevalence of and Factors Associated with Sarcopenia in Korean Cancer Survivors: Based on Data Obtained by the Korea National Health and Nutrition Examination Survey (KNHANES) 2008–2011

Using a representative dataset from the Korea National Health and Nutrition Examination Survey (KNHANES) from 2008 to 2011, we analyzed anthropometric and dual-energy X-ray absorptiometry (DXA)-determined body composition findings for 493 cancer survivors (mean age a61.1 ± 12.6 years; 35.7% male). A much higher proportion of men (30.1%) than women (0.6%) met the criteria of sarcopenia. Subjects with a history of lung cancer, genitourinary cancer, or gastric cancer were prone to develop sarcopenia (31.6%, 26.3%, and 21.4%, respectively). Furthermore, sarcopenia was more prevalent among elderly (≥65 years; P < 0.001), those with a lower BMI level (<23 kg/m²; P < 0.001), heavy drinker (P = 0.012), or smoker (P < 0.001), and those with inadequate intakes of protein (P = 0.017) and vitamin A (P = 0.024). Multivariable logistic analyses revealed sarcopenia was significantly associated with male gender (odds ratio [OR], 68.14; 95% CI, 15.52–299.13), a BMI of <23 kg/m² (OR 35.93, 95% CI, 8.24–156.67), and inadequate protein intake (OR 3.07, 95% CI, 1.30–7.22); these factors are significant predictors of sarcopenia in Korean cancer survivors.     

The impact of school-day variation in weight and height on National Child Measurement Programme body mass index-determined weight category in Year 6 children

Background In England, the National Child Measurement Programme (NCMP) annually measures the weight and height of Year 6 schoolchildren (age 10–11 years). While measurement protocols are defined, the time of measurement within the school day is not. This study examined the impact of school‐day variation in weight and height on NCMP body mass index (BMI)‐determined weight category in Year 6 children. Methods Standing height and weight were measured in morning and afternoon sessions in 74 children, boys (n= 34; height: 141.16 ± 7.45 cm; weight: 36.48 ± 9.46 kg, BMI: 18.19 ± 3.98 kg/m²) and girls (n= 40; height: 144.58 ± 7.66 cm; weight: 42.25 ± 11.29 kg; BMI: 19.97 ± 3.98 kg/m²) aged 11 ± 0.3 years. Results In the whole sample, height decreased (Mean =?0.51 cm, 95% CI: ?0.39 to ?0.64 cm, P= 0.01), weight did not change (Mdn = 36.40 to 36.35, P= 0.09) and BMI increased (Mdn = 18.04 to 18.13, P= 0.01). In girls weight increased (Mdn = 41.40 to 41.60, P= 0.01). BMI percentile increased (Mdn = 57th to 59.5th centile, P= 0.01). One girl increased in BMI category from morning to afternoon according to the clinical cut‐offs (≤2nd, >91st and >98th) and three girls increased BMI category according to the population monitoring cut‐offs (≤2nd, ≥85th, ≥95th). Conclusions School‐day variation in height (and in girls alone, weight) impact upon increased BMI and BMI percentile in afternoon versus morning measurements in Year 6 children. Although not reaching statistical significance, resultant variation in categorization at the individual level may lead to unwarranted follow‐up procedures being initiated. Further research with larger samples is required to further explore the impact of daily variability in height and weight upon both clinical and population monitoring BMI‐determined weight status categorization in the NCMP.     

Early LV remodelling patterns in overweight and obesity: Feasibility of cardiac CT to detect early geometric left ventricular changes

BackgroundObesity is an in independent risk factor for cardiovascular disease.GoalTo describe the early LV remodelling pattern in patients with overweight and obesity and structurally normal hearts.MethodsConsecutive patients (n = 2374), with structurally normal hearts and BMI ≥ 18.5 kg/m², undergoing prospective mid-diastolic ECG gated CTCA were selected. Left ventricular mass (LVM) and Left ventricular mid-diastolic volume (LVMDV) were measured. The concentricity index (LVM/LVMDV) were calculated. According to the definitions of the World Health Organization (WHO), the patients were divided into weight categories.ResultsThe mean LVM ± Std. deviation in the subgroups according to WHO classification was 101.68 ± 28.99 g (normal weight), 115.79 ± 29.14 g (overweight), 123.8 ± 33.44 g (class I obesity), 125.85 ± 32.89 g (class II obesity) and 132.45 ± 37.85 g (class III obesity). (p < 0.001)The mean LVMDV progressed with increasing WHO weight category from 112.37 ± 36.46 in patients with normal BMI to 140.26 ± 43.78 in patients with class III obesity. (p < 0.001)The concentricity index was 0.935 ± 0.216 g/ml in patients with normal BMI, 0.979 ± 0.253 g/ml, 1.058 ± 0.635 g/ml, 0.996 ± 0.284 g/ml and 0.9768 ± 0.244 g/ml in patients with BMI categories 25–29.99, 30–34.99, 35–39.99 and ≥40 kg/m², respectively.ConclusionsOur study demonstrates a non-linear (inverse U-shape) relationship between increasing BMI class and concentricity index, reaching its maximum at a BMI of 30–34.99 kg/m². Further increase in BMI results in LV dilation.     

Effects of a 12-Week Lifestyle Intervention on Health Outcome and Serum Adipokines in Middle-Aged Korean Men with Borderline High Blood Pressure

Background: High blood pressure, in relation to blood levels of adipokines such as adiponectin and leptin, is highly associated with an unhealthy lifestyle including sedentary behaviors, poor dietary habits such as excess sodium intake, and heavy drinking. Strategies to reduce blood pressure may benefit the levels of adipokines.

Objective: Thus, we aimed to investigate the effects of lifestyle intervention on blood pressure and serum adipokines in middle-aged Korean men with borderline high blood pressure (systolic blood pressure [SBP] ≥ 130 mm Hg or diastolic blood pressure [DBP] ≥ 85 mm Hg).

Methods: Fifty-two men (aged 42.5 ± 8.5 years) with normal weight (body mass index [BMI] < 25 kg/m²) and high BP (NH group) and 40 men (age 42.0 ± 8.4 years) who were obese (BMI ≥ 25 kg/m²) with high BP (OH group) underwent 5 sessions of one-on-one intensive counseling including instruction on a nutritionally balanced diet, a low-sodium diet, how to understand calorie requirements, and strategies to implement regular exercise for blood pressure regulation over 12 weeks. In order to increase the awareness of sodium education, a salt sensory test using an unseasoned soup was performed. Anthropometrics, blood pressure measurements, 24-hour recalls were performed, and blood levels of lipids, fasting plasma glucose, C-reactive protein (CRP), leptin, and adiponectin were analyzed at week 0 and at week 12. Sodium consumption was roughly estimated using the Dish-based Frequency Questionnaire–15.

Results: Weight, BMI, body fat (kg and %), waist circumference, hip circumference, and blood pressure were significantly decreased after 12 weeks (p < 0.05) in all subjects. Similarly, total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and CRP were decreased (p < 0.05), but LDL-C/HDL-C was significantly decreased (p < 0.01) only in the obese subjects. At baseline, blood levels of leptin were significantly higher in the obese subjects than in the normal weight subjects. In the obese subjects, a significantly negative correlation was found between leptin levels at baseline and percentage change in DBP (r = –0.338, p < 0.05). After 12 weeks, blood levels of adipokines did not show significant changes.

Conclusions: These results suggest that a short-term (12 weeks) lifestyle intervention had positive effects on blood pressure control and weight reduction in the subjects, but not on their blood levels of adipokines. It is interesting that blood level of baseline leptin was negatively associated with the changes in blood pressure after this short-term intervention.     

SGA Scores Have Poor Correlation With Serum Albumin in Obese Hemodialysis Patients: A Secondary Analysis

ObjectiveThe objective of this study was to determine the relationship between serum albumin and the Subjective Global Assessment (SGA) in a sample of obese hemodialysis (HD) patients.Design and MethodStudy subjects (N = 253) included patients who were categorized into well-nourished (68%, SGA score 6-7) and malnourished (score 1-5) groups, and, on the basis of the body mass index (BMI), into obese (BMI > 30 kg/m²; 35%) and nonobese (BMI < 30 kg/m²). The mean baseline data (±standard deviation) were as follows: age, 63.5 ± 14.3 years; BMI, 29 ± 8 kg/m²; and serum albumin, 3.8 ± 0.4 mg/dL (bromocresol green). The secondary analysis of data from the SGA Validation Project and Nutrition Algorithm Preliminary Report determined the relationship between the 7-point SGA and serum albumin concentrations in a sample of obese HD patients. Data were analyzed at Case Western Reserve University from a total of 253 HD patients.Main Outcome MeasureThe SGA scores in the BMI groups were compared with serum albumin as an objective measure of nutrition and inflammation risk.ResultsBy using analysis of variance, the obese and nonobese populations showed statistically significant differences in SGA scores (obese: P < .3468, nonobese: P < .0080) and serum albumin values (obese, P < .0943; nonobese, P < .0183) between well-nourished and malnourished groups. A multivariable nominal logistic fit was used to predict SGA group with age and gender as covariates. Serum albumin values (P < .0057) and BMI values greater than 30 (P < .0090) predicted SGA group.ConclusionThe secondary analysis showed that SGA does not correlate well with serum albumin; thus, it may not be a valid nutrition assessment tool among obese HD patients.     

A meal replacement regimen improves blood glucose levels in prediabetic healthy individuals with impaired fasting glucose

ObjectiveThe aim of this study was to investigate the effect of a 6-wk intervention with either lifestyle intervention (increased physical activity and a low-calorie diet) or a meal replacement regimen on glycemic control in patients who are prediabetic and have impaired fasting glucose.MethodsForty-two overweight or obese men and women (age 54 ± 8 y; weight 95.1 ± 11.9 kg; body mass index [BMI] 32.8 ± 2.89 kg/m²) were included in this randomized controlled clinical trial. Patients in the lifestyle group (LS; n = 14) received dietary counseling sessions (fat-restricted low-calorie diet) and instructions on how to increase physical activity. Patients in the meal replacement group (MR; n = 28) were instructed to replace two daily meals with a low-calorie, high soy-protein drink with a low glycemic index.ResultsBoth interventions resulted in a significant decrease in body weight and BMI, although the reduction was more pronounced (P < 0.05) in the MR group. In both groups, glucose concentrations decreased significantly (LS: −12 mg/dL, P < 0.01; MR: −11 mg/dL, P < 0.01), and mean glucose levels returned to the normal range. Insulin (LS: −1 μU/mg [not significant]; MR: −6.3 μU/mg, P < 0.01) and homeostasis model assessment of insulin resistance (HOMA-IR; LS −0.92, P < 0.01; MR: −2.1, P < 0.01) were also significantly lower following both interventions; again improvements were more pronounced in the MR group (insulin: P < 0.05; HOMA P < 0.01)ConclusionIt can be concluded that meal replacement is an effective intervention for rapid improvement of elevated fasting glucose and increased insulin concentrations, these being important biomarkers of the prediabetic state. The 6-wk intervention has shown that the effect of meal replacement on fasting blood glucose was comparable to the effect of lifestyle intervention. The alterations in BMI, insulin, and HOMA-IR were significantly more pronounced following the meal replacement regimen.     

Randomized,double-blind,placebo-controlled trial to evaluate efficacy of ketodiet in predialytic chronic renal failure

ObjectiveTo assess whether a ketodiet, a combination of ketoanalogs of essential amino acids (KAs) and a very low-protein diet, retards progression of chronic renal failure and maintains nutritional status.DesignA prospective, randomized, double-blind, placebo-controlled trial.SettingNephrology outpatient department in Northern Railways Central Hospital, New Delhi, India.PatientsThirty-four patients in predialytic stages of chronic renal failure (CRF), randomized to 2 comparable groups in terms of age, sex distribution, blood pressure control, etiology, use of angiotensin converting enzyme inhibitors, serum creatinine, glomerular filtration rate (GFR), and body mass index (BMI).InterventionSubjects randomly received either 0.6 g/kg/d protein plus placebo (n = 16) or 0.3 g/kg/d protein plus tablets of KAs (Ketosteril; Fresenius Kabi, Germany) (n = 18) for 9 months. A dietician administered the diet as well as the KAs or the placebo to the patients.Outcome measuresChanges in GFR and renal and nutritional parameters were measured.ResultsMean (± SD) GFR measured by the ^99mTc-DTPA (99 m technetium diethylenetri-aminepenta-aceticacid) plasma sample method was unchanged in the ketodiet group: 28.1 ± 8.8 (before) and 27.6 ± 10.1 mL/min/1.73 m² (after the study) (P = .72). However, it significantly decreased from 28.6 ± 17.6 to 22.5 ± 15.9 mL/min/1.73 m² in the placebo group (P = .015). Serum creatinine before and after the study in the ketodiet group was 2.26 ± 1.03 mg/dL and 2.07 ± 0.8 mg/dL (P = .90) and in the placebo group was 2.37 ± 0.85 and 3.52 ± 2.9 mg/dL (P = .066), respectively. In both groups the mean BMI did not change from 25.4 ± 4.2 to 24.5 ± 4.2 kg/m² (P = .46) for ketodiet and from 25.0 ± 6.8 to 23.9 ± 4.1 kg/m² (P = .39) for the placebo group. Serum total proteins decreased significantly (P = .038) in the placebo group, and serum albumin showed a trend (P = .061) toward reduction, whereas both of these parameters were maintained in the ketodiet group.ConclusionOver a 9-month period, very low-protein diet supplemented with ketoanalogs helped CRF patients to preserve GFR and maintain BMI. KAs were safe and efficacious in retarding the progression of renal failure and preserving the nutritional status of CRF patients.     

Efficacy,safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results

ObjectiveTo assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA^?) containing levonorgestrel (LNG) and ethinyl estradiol (EE).Study designThis single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used.ResultsThe study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m². In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5–7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9–5.8) in women with BMI <30 kg/m² and 8.6 (5.8–11.5) in women with BMI ≥30 kg/m². Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m²) reported thromboembolic events considered related to treatment.ConclusionsThe low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m². The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLA^? for prevention of pregnancy in women with BMI <30 kg/m².ImplicationsTDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m². TDS has reduced effectiveness in women with BMI ≥30 kg/m².