Effect of time restricted eating versus daily calorie restriction on sex hormones in males and females with obesity.

This study examined the effects of time restricted eating (TRE) on sex hormones in males and females, versus daily calorie restriction (CR). Adults with obesity (n = 90) were randomized to 1 of 3 groups for 12-months: 8-h TRE (eating only between 12:00 to 8:00 pm, with no calorie counting); CR (25% energy restriction daily); or control. Body weight decreased (P < 0.01) in the TRE and CR groups, relative to controls, in males, premenopausal females, and postmenopausal females, by month 12. Total testosterone, dehydroepiandrosterone (DHEA), and sex hormone binding globulin (SHBG) levels did not change over time, or between groups, in males, premenopausal females, and postmenopausal females. Estradiol, estrone, and progesterone were only measured in postmenopausal females, and remained unchanged. These findings suggest that TRE produces significant weight loss but does not impact circulating sex hormone levels in males and females with obesity over 12 months, relative to CR and controls.

Effect of time restricted eating versus daily calorie restriction on sex hormones in males and females with obesity.

This study examined the effects of time restricted eating (TRE) on sex hormones in males and females, versus daily calorie restriction (CR). Adults with obesity (n = 90) were randomized to 1 of 3 groups for 12-months: 8-h TRE (eating only between 12:00 to 8:00 pm, with no calorie counting); CR (25% energy restriction daily); or control. Body weight decreased (P < 0.01) in the TRE and CR groups, relative to controls, in males, premenopausal females, and postmenopausal females, by month 12. Total testosterone, dehydroepiandrosterone (DHEA), and sex hormone binding globulin (SHBG) levels did not change over time, or between groups, in males, premenopausal females, and postmenopausal females. Estradiol, estrone, and progesterone were only measured in postmenopausal females, and remained unchanged. These findings suggest that TRE produces significant weight loss but does not impact circulating sex hormone levels in males and females with obesity over 12 months, relative to CR and controls. Trial registration: Clinicaltrials.gov , NCT04692532 .

Time-restricted eating: Watching the clock to treat obesity.

Time-restricted eating (TRE) has become a popular strategy to treat obesity. TRE involves confining the eating window to 4-10 h per day and fasting for the remaining hours (14-20 h fast). During the eating window, individuals are not required to monitor food intake. The sudden rise in popularity of TRE is most likely due to its simplicity and the fact that it does not require individuals to count calories to lose weight. This feature of TRE may appeal to certain individuals with obesity, and this could help produce lasting metabolic health improvements. The purpose of this review is to summarize current evidence from randomized clinical trials of TRE (without calorie counting) on body weight and metabolic risk factors. The efficacy of TRE in various populations groups, including those with obesity, type 2 diabetes (T2DM), and polycystic ovary syndrome (PCOS), is also examined.

Efficacy and safety of prolonged water fasting: a narrative review of human trials.

The goal of this narrative review is to summarize the effects of prolonged fasting on various metabolic health measures, including body weight, blood pressure, plasma lipids, and glycemic control. Prolonged fasting is characterized by consciously eating little to no food or caloric beverages for several days to weeks. Results reveal that prolonged fasting for 5-20 days produces potent increases in circulating ketones, and mild to moderate weight loss of 2-10%. Approximately two-thirds of the weight lost is lean mass, and one-third is fat mass. The excessive lean mass loss suggests that prolonged fasting may increase the breakdown of muscle proteins, which is a concern. Systolic and diastolic blood pressure consistently decreased with prolonged fasting. However, the impact of these protocols on plasma lipids is less clear. While some trials demonstrate decreases in LDL cholesterol and triglycerides, others show no benefit. With regard to glycemic control, reductions in fasting glucose, fasting insulin, insulin resistance, and glycated hemoglobin (HbA1c) were noted in adults with normoglycemia. In contrast, these glucoregulatory factors remained unchanged in patients with type 1 or type 2 diabetes. The effects of refeeding were also examined in a few trials. It was shown that 3-4 months after the fast was completed, all metabolic benefits were no longer observed, even when weight loss was maintained. With regard to adverse events, metabolic acidosis, headaches, insomnia, and hunger were observed in some studies. In summary, prolonged fasting appears to be a moderately safe diet therapy that can produce clinically significant weight loss (>5%) over a few days or weeks. However, the ability of these protocols to produce sustained improvements in metabolic markers warrants further investigation.

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Time-restricted eating (TRE) has become increasingly popular, yet longer-term randomized clinical trials have not evaluated its efficacy and safety in patients with type 2 diabetes (T2D). Objective: To determine whether TRE is more effective for weight reduction and glycemic control than daily calorie restriction (CR) or a control condition in adults with T2D. Design, Setting, and Participants: This 6-month, parallel-group, randomized clinical trial was performed between January 25, 2022, and April 1, 2023, at the University of Illinois Chicago. Participants were aged 18 to 80 years with obesity and T2D. Data analysis was based on intention to treat. Interventions: Participants were randomized to 1 of 3 groups: 8-hour TRE (eating 12 to 8 pm only, without calorie counting), CR (25% energy restriction daily), or control. Main Outcomes and Measures: The primary outcome measure was change in body weight by month 6. Secondary outcomes included changes in hemoglobin A1c (HbA1c) levels and metabolic risk factors. Results: Seventy-five participants were enrolled with a mean (SD) age of 55 (12) years. The mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 39 (7) and the mean (SD) HbA1c level was 8.1% (1.6%). A total of 53 participants (71%) were women. One participant (1%) was Asian, 30 (40%) were Hispanic White, 40 (53%) were non-Hispanic Black, and 4 (5%) were non-Hispanic White. Participants in the TRE group were adherent with their eating window on a mean (SD) of 6.1 (0.8) days per week, and 17 (68%) in the CR group were adherent with their prescribed calorie goals over 6 months. The mean (SD) reduction in energy intake was -313 (509) kcal/d for TRE, -197 (426) kcal/d for CR, and -16 (439) kcal/d for controls. By month 6, body weight decreased significantly in the TRE group (-3.56% [95% CI, -5.92% to -1.20%]; P = .004) but not the CR group (-1.78% [95% CI, -3.67% to 0.11%]; P = .06), relative to controls. Levels of HbA1c decreased in the TRE (-0.91% [95% CI, -1.61% to -0.20%]) and CR (-0.94% [95% CI, -1.59% to -0.30%]) groups, relative to controls, with no differences between the TRE and CR groups. Time in euglycemic range, medication effect score, blood pressure, and plasma lipid levels did not differ among groups. No serious adverse events were reported. Conclusions and relevance: This randomized clinical trial found that a TRE diet strategy without calorie counting was effective for weight loss and lowering of HbA1c levels compared with daily calorie counting in a sample of adults with T2D. These findings will need to be confirmed by larger RCTs with longer follow-up. Trial Registration: ClinicalTrials.gov Identifier: NCT05225337.

Effect of Time-Restricted Eating versus Daily Calorie Restriction on Mood and Quality of Life in Adults with Obesity.

The purpose of this secondary analysis is to compare the effects of two popular weight loss regimens, time-restricted eating (TRE) and daily calorie restriction (CR), on mood and quality-of-life measures in adults with obesity. Ninety participants were randomized to one of three interventions for 12 months: 8 h TRE (eating only between 12:00 and 8:00 p.m., with no calorie counting); CR (25% energy restriction daily); or no-intervention control group. Questionnaires were administered to measure mood (Beck Depression Inventory-II (BDI-II), and Profile of Mood States (POMS)) and quality of life (Rand 36-Item Short Form) at baseline and month 12. Body weight decreased in the TRE group (-4.87%, 95%CI: -7.61, -2.13) and CR group (-5.30%, 95%CI: -9.06, -1.54) versus controls, with no difference between TRE and CR. The BDI-II depression score did not change in the TRE or CR group, versus controls, by month 12. Likewise, there were no changes in any of the POMS subscales (tension, depression, anger, fatigue, anger, confusion, or vigor) or the total mood disturbance score in the TRE or CR group versus controls. As for quality of life, there were no significant changes in the SF-36 constructs of mental health, bodily pain, and general physical health in the TRE or CR group versus controls. However, there was a trend towards increased vitality in the TRE group (7.77 [95% CI: 0.15, 15.39] p = 0.05) relative to controls. There were no associations between changes in body weight, physical activity, mood, and quality of life in any group by the end of the study. These findings suggest that TRE and CR produce similar degrees of weight loss, but impact neither mood nor quality of life in adults with obesity over 12 months. Future well-powered studies will be needed to confirm these findings.

Time-Restricted Eating Without Calorie Counting for Weight Loss in a Racially Diverse Population : A Randomized Controlled Trial.

BACKGROUND: Time-restricted eating (TRE), without calorie counting, has become a popular weight loss strategy, yet long-term randomized trials evaluating its efficacy are limited. OBJECTIVE: To determine whether TRE is more effective for weight control and cardiometabolic risk reduction compared with calorie restriction (CR) or control. DESIGN: 12-month randomized controlled trial. (ClinicalTrials.gov: NCT04692532). SETTING: University of Illinois Chicago from January 2021 to September 2022. PARTICIPANTS: 90 adults with obesity. INTERVENTION: 8-hour TRE (eating between noon and 8:00 p.m. only, without calorie counting), CR (25% energy restriction daily), or control (eating over a period of 10 or more hours per day). Participants were not blinded. MEASUREMENTS: Change in body weight, metabolic markers, and energy intake by month 12. RESULTS: Seventy-seven persons completed the study. Mean age was 40 years (SD, 11), 33% were Black, and 46% were Hispanic. Mean reduction in energy intake was -425 kcal/d (SD, 531) for TRE and -405 kcal/d (SD, 712) for CR. Compared with the control group, weight loss by month 12 was -4.61 kg (95% CI, -7.37 to -1.85 kg; P ≤ 0.01) (-4.87% [CI, -7.61% to -2.13%]) for the TRE group and -5.42 kg (CI, -9.13 to -1.71 kg; P ≤ 0.01) (-5.30% [CI, -9.06% to -1.54%]) for the CR group, with no statistically significant difference between TRE and CR (0.81 kg [CI, -3.07 to 4.69 kg; P = 0.68]) (0.43% [CI, -3.48% to 4.34%]). LIMITATION: Not blinded, not powered to detect relatively large differences in weight loss, and lack of adjustment for multiple comparisons. CONCLUSION: Time-restricted eating is more effective in producing weight loss when compared with control but not more effective than CR in a racially diverse population. PRIMARY FUNDING SOURCE: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.

Effect of intermittent fasting on circulating inflammatory markers in obesity: A review of human trials.

Obesity is associated with low-grade inflammation. Weight loss, by means of dietary restriction, has been shown to reduce systemic inflammation. Intermittent fasting has recently gained popularity as a weight loss diet, but its effects on inflammatory markers in individuals with obesity have yet to be summarized. Accordingly, this review examined how the two main forms of intermittent fasting, i.e., time restricted eating (TRE) and alternate day fasting (ADF), impact body weight and key circulating inflammatory markers (i.e., C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), and interleukin-6 (IL-6)), in adults with obesity. Results from this review reveal that TRE with various eating window durations (4-10 h per day) has no effect on circulating levels of CRP, TNF-alpha or IL-6, with 1-5% weight loss. As for ADF, reductions in CRP concentrations were noted when >6% weight loss was achieved. However, ADF had no effect on TNF-alpha or IL-6 concentrations, with this degree of weight loss. Thus, intermittent fasting has little or no effect on key inflammatory markers, but more research is warranted to confirm these preliminary findings.

Protocol for measuring intrahepatic triglyceride content in adults with non-alcohol fatty liver disease.

Here, we present a protocol for conducting magnetic resonance imaging proton density fat fraction (MRI-PDFF) to measure intrahepatic triglyceride (IHTG) content in adults with non-alcohol fatty liver disease (NAFLD). We describe steps for screening patients for NAFLD, MRI-PDFF scanning, and using MRI-PDFF data to quantify IHTG. This protocol can be repeated sequentially and used in weight loss trials. However, it is limited to patients with NAFLD as it does not assess non-alcoholic steatohepatitis or hepatic fibrosis. For complete details on the use and execution of this protocol, please refer to Ezpeleta et al. (2023).1.

Alternate-Day Fasting Combined with Exercise: Effect on Sleep in Adults with Obesity and NAFLD.

Objective: This study investigated how alternate-day fasting (ADF) combined with aerobic exercise impacts body weight and sleep in adults with non-alcoholic fatty liver disease (NAFLD). Methods: Adults with obesity and NAFLD (n = 80) were randomized into one of four groups for 3 months: combination of ADF (600 kcal "fast day," alternated with an ad libitum intake "feast day") and moderate-intensity aerobic exercise (five sessions per week, 60 min/session); ADF alone; exercise alone; or a no-intervention control group. Results: By month 3, body weight and intrahepatic triglyceride content decreased (p < 0.001, group × time interaction) in the combination group versus the exercise group and control group, but not versus the ADF group. Sleep quality, measured by the Pittsburgh Sleep Quality Inventory (PSQI), did not change in the combination group (baseline: 6.0 ± 0.7; month 3: 5.6 ± 0.7), ADF group (baseline: 8.9 ± 1.0; month 3: 7.5 ± 0.8), or exercise group (baseline: 6.4 ± 0.6; month 3: 6.7 ± 0.6), versus controls (baseline: 5.5 ± 0.7; month 3: 4.6 ± 0.5). Wake time, bedtime, sleep duration, and insomnia severity did not change (no group x time interaction) over the course of the study in any group. Risk for obstructive sleep apnea was present in 30% of combination subjects, 75% of ADF subjects, 40% of exercise subjects, and 75% of controls, and did not change in the intervention groups, versus controls, by month 3. No associations were observed between changes in body weight, intrahepatic triglyceride content, and any sleep outcome. Conclusions: The weight loss induced by ADF combined with exercise does not improve sleep quality, duration, insomnia severity, or risk of obstructive sleep apnea in individuals with NAFLD.

Effect of alternate day fasting combined with aerobic exercise on non-alcoholic fatty liver disease: A randomized controlled trial.

Innovative non-pharmacological lifestyle strategies to treat non-alcoholic fatty liver disease (NAFLD) are critically needed. This study compared the effects of alternate day fasting (ADF) combined with exercise to fasting alone, or exercise alone, on intrahepatic triglyceride (IHTG) content. Adults with obesity and NAFLD (n = 80, 81% female, age: 23-65 years) were randomized to 1 of 4 groups for 3 months: combination of ADF (600 kcal/2,500 kJ "fast day" alternated with an ad libitum intake "feast day") and moderate-intensity aerobic exercise (5 session per week, 60 min/session); ADF alone; exercise alone; or a no-intervention control group. By month 3, IHTG content was significantly reduced in the combination group (-5.48%; 95% CI, -7.77% to -3.18%), compared with the exercise group (-1.30%; 95% CI, -3.80% to 1.20%; p = 0.02) and the control group (-0.17%; 95% CI, -2.17% to 1.83%; p < 0.01) but was not significantly different versus the ADF group (-2.25%; 95% CI, -4.46% to -0.04%; p = 0.05). Body weight, fat mass, waist circumference, and alanine transaminase (ALT) levels significantly decreased, while insulin sensitivity significantly increased in the combination group compared with the control group. Lean mass, aspartate transaminase (AST), HbA1c, blood pressure, plasma lipids, liver fibrosis score, and hepatokines (fetuin-A, FGF-21, and selenoprotein P) did not differ between groups. Combining intermittent fasting with exercise is effective for reducing hepatic steatosis in patients with NAFLD but may offer no additional benefit versus fasting alone.

Effect of Intermittent Fasting on Reproductive Hormone Levels in Females and Males: A Review of Human Trials.

Intermittent fasting is a popular diet for weight loss, but concerns have been raised regarding the effects of fasting on the reproductive health of women and men. Accordingly, we conducted this literature review to clarify the effects of fasting on reproductive hormone levels in humans. Our results suggest that intermittent fasting decreases androgen markers (i.e., testosterone and the free androgen index (FAI)) while increasing sex hormone-binding globulin (SHBG) levels in premenopausal females with obesity. This effect was more likely to occur when food consumption was confined to earlier in the day (eating all food before 4 pm). In contrast, fasting did not have any effect on estrogen, gonadotropins, or prolactin levels in women. As for men, intermittent fasting reduced testosterone levels in lean, physically active, young males, but it did not affect SHBG concentrations. Interestingly, muscle mass and muscular strength were not negatively affected by these reductions in testosterone. In interpreting these findings, it is important to note that very few studies have been conducted on this topic. Thus, it is difficult to draw solid conclusions at present. From the limited data presented here, it is possible that intermittent fasting may decrease androgen markers in both genders. If this is the case, these results would have varied health implications. On the one hand, fasting may prove to be a valuable tool for treating hyperandrogenism in females with polycystic ovarian syndrome (PCOS) by improving menstruation and fertility. On the other hand, fasting may be shown to decrease androgens among males, which could negatively affect metabolic health and libido. More research is warranted to confirm these preliminary findings.

Reliability and Validity of the Greek Version of the Professional Quality of Life Scale (ProQOL-V).

BACKGROUND: Compassion constitutes a central element of all health and social care professions. The Professional Quality of Life Questionnaire is the most widely used instrument to measure compassion fatigue worldwide. OBJECTIVE: The aim of this study was to provide evidence for the reliability and the validity of ProQOL-V for Greece. METHODS: A total of 261 nurses selected by convenience sampling and required to complete the ProQOL and Secondary Traumatic Stress Scale (STSS). The reliability and validity of the scale was evaluated by correlation analysis, t-test, and confirmatory factor analysis. RESULTS: The overall Cronbach's a for Compassion Satisfaction was 0.87 ranging from 0.86 to 0.87 with individual items deleted, for Burn-out was 0.73 ranging from 0.71 to 0.79 with individual items deleted and for Secondary Traumatic Stress was 0.83 ranging from 0.81 to 0.84 with individual items deleted. Additionally, the Pearson correlation r for Compassion Satisfaction, Burn-out and Secondary Traumatic Stress showed strong correlations between test-retest measurements (p<0.001). Secondary Traumatic Stress and Burn-out were positively correlated to STSS as expected (r=0.69 for Secondary Traumatic Stress and r=0.57 for Burn-out) implying sufficient convergent validity. In contrast, Compassion Satisfaction was negatively correlated to STSS as expected (r=-0.25) implying sufficient divergent validity. Goodness-of-fit indices included TLI=0.856, CFI=0.895, and RMSEA=0.063 supporting the construct validity of the three-dimensional instrument. CONCLUSION: ProQOL-V has good reliability and validity among nurses in Greece. The implications of relevant future research are important in relation to the health care management and the support and continuous education of front-line health and social care workers.

Changes in subjective measures of appetite during 6 months of alternate day fasting with a low carbohydrate diet.

OBJECTIVE: Alternate day fasting (ADF) has been shown to lower body weight and improve subjective appetite by increasing fullness. What remains unknown, however, is whether carbohydrate restriction during ADF would provide additional weight loss benefits by helping to lower hunger as well. Accordingly, this study examined the effect of 6-months of ADF combined with a low carbohydrate diet on fasting and postprandial appetite ratings. METHODS: Adults with obesity (n = 31) participated in ADF (600 kcal "fast day" alternated with an ad libitum "feast day") with a low-carbohydrate background diet (30% carbohydrates, 35% protein, and 35% fat). The 6-month trial consisted of a 3-month weight loss period followed by a 3-month weight maintenance period. RESULTS: After 6-months of an ADF-low carbohydrate diet, body weight decreased (P < 0.01) by 6.2 ± 1.0 kg, relative to baseline. Subjective hunger and fullness did not change throughout the study. Fasting insulin decreased (P < 0.05) by 3.3 ± 1.3 µlU/mL by month 6, relative to baseline. Fasting glucose and insulin resistance, remained unchanged over the course of the study. Hunger and fullness were not related to body weight, glucoregulatory factors or energy intake. CONCLUSIONS: These findings suggest that ADF combined with a low carbohydrate diet is not associated with any changes in appetite, relative to baseline. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03528317.

Effects of 4- and 6-h Time-Restricted Feeding on Weight and Cardiometabolic Health: A Randomized Controlled Trial in Adults with Obesity.

Time-restricted feeding (TRF) regimens have grown in popularity; however, very few studies have examined their weight-loss efficacy. We conducted the first human trial (Clinicaltrials.gov NCT03867773) to compare the effects of two popular forms of TRF (4 and 6 h) on body weight and cardiometabolic risk factors. Adults with obesity were randomized to 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions). After 8 weeks, 4- and 6-h TRF produced comparable reductions in body weight (∼3%), insulin resistance, and oxidative stress, versus controls. Energy intake was reduced by ∼550 kcal/day in both TRF groups, without calorie counting. These findings suggest that 4- and 6-h TRF induce mild reductions in body weight over 8 weeks and show promise as interventions for weight loss. These diets may also improve some aspects of cardiometabolic health.

Translation and Cultural Adaptation of the Professional Quality of Life Scale (ProQOL V) for Greece.

INTRODUCTION: Compassion constitutes a central element of all health and social care professions. The Professional Quality of Life Questionnaire is the most widely used instrument to measure compassion fatigue worldwide. AIM: The aim of this study was to culturally adapt the ProQOL V for Greece. METHOD: Forward-translations and back-translations were conducted by two bilingual translators (English-Greek) grown up in English speaking countries (USA, Australia) while cross-cultural adaptation followed strictly the recent WHO guidelines. RESULTS: A five-member expert-panel convened by the first author in order to identify and discuss inadequate expressions/concepts of the forward/backward translation resolved all discrepancies and reached consensus after two panel meetings. Overall, 90.0% of participants considered the instrument very good or good, and items were found relevant, easy to understand and with appropriate alternative answer categories for the three dimensions of CF. CONCLUSION: High quality self-report measures are necessary in evidence-based health and social care research and practice. Participants in a pre-test of the latest cross-culturally adapted version of ProQOL V verified the readability, comprehensibility and suitability of the instruments' items. After completion of the validation of the ProQOL V, it will become available to Greek researchers.

Alternate day fasting combined with a low-carbohydrate diet for weight loss, weight maintenance, and metabolic disease risk reduction.

OBJECTIVE: Alternate day fasting (ADF) is a popular weight loss regimen. Whether carbohydrate restriction can enhance the weight loss achieved with ADF remains unclear. Accordingly, this study examined the effect of ADF combined with a low-carbohydrate diet on body weight and metabolic disease risk factors. METHODS: Adults with obesity (n = 31) participated in ADF (600 kcal "fast day" alternated with an ad libitum "feast day") with a low-carbohydrate background diet (30% carbohydrates, 35% protein, and 35% fat). The 6-month trial consisted of a 3-month weight loss period followed by a 3-month weight maintenance period. RESULTS: Body weight decreased (-5.5 ± 0.5%; P < .001) during the weight loss period (month 0-3) but remained stable (P = .57) during the weight maintenance period (month 4-6). Net weight loss by month 6 was -6.3 ± 1.0%. Fat mass was reduced (P < .01) by month 6, while lean mass and visceral fat mass remained unchanged. Total cholesterol and low-density lipoprotein (LDL) cholesterol levels decreased (P < .05) by -6 ± 2% and - 8 ± 3%, respectively, by month 6. Systolic blood pressure was also reduced (P = .03) by -7 ± 3 mm Hg. Fasting insulin decreased (P = .03) by -24 ± 8% by month 6 relative to baseline. High-density lipoprotein (HDL) cholesterol, triglycerides, diastolic blood pressure, heart rate, fasting glucose, homeostatic model assessment of insulin resistance (HOMA-IR), and haemoglobin A1C (HbA1c) remained unchanged. CONCLUSIONS: These findings suggest that ADF combined with a low-carbohydrate diet is effective for weight loss, weight maintenance, and improving certain metabolic disease risk factors such as LDL cholesterol, blood pressure, and fasting insulin. While these preliminary findings are promising, they still require confirmation by a randomized control trial.