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Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.
Rotter, G, Teut, M, Schleicher, R, Dell'Oro, M, Ortiz, M, Binting, S, Tissen-Diabaté, T, Roll, S, Michalsen, A, Staab, D, et al
Journal of integrative and complementary medicine. 2023;29(2):99-110
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Relaxation techniques, diet, and exercise can diminish atopic dermatitis (AD) symptoms. Patients with AD worry about the side-effects of the medical treatment for AD thus the majority try to engage in potentially healthy lifestyle behaviours. The aim of this study was to exploratively investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in adult AD patients This study is a four-armed, randomised controlled, single-centre, open explorative clinical trial. Patients were randomly assigned to one of the four groups: i) hypnotherapy group program (HTP), ii) intermittent fasting with diet adjustment group program (IFDP), iii) an exercise group program or the control group. The study was strongly impacted by confinements and research restrictions due to the coronavirus 2019 pandemic. However, results showed potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Authors conclude that further high-quality clinical trials should be performed investigating the effectiveness and safety of hypnotherapy, fasting with diet adjustments, as well as exercise.
Abstract
Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.
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Alternate-Day Fasting Combined with Exercise: Effect on Sleep in Adults with Obesity and NAFLD.
Ezpeleta, M, Gabel, K, Cienfuegos, S, Kalam, F, Lin, S, Pavlou, V, Varady, KA
Nutrients. 2023;15(6)
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Non-alcoholic fatty liver disease (NAFLD) is defined as the presence of 5% or more fat in the liver, confirmed by hepatic imaging or biopsy. Poor sleep may adversely affect insulin sensitivity and inflammatory status, thereby contributing to the development and progression of NAFLD. The aim of this study was to investigate how intermittent fasting combined with exercise impacts body weight and sleep measures in adults with NAFLD. This study was a secondary analysis of a 3-month randomised, controlled, parallel-arm study. Participants were randomized to 1 of 4 intervention groups: alternate-day fasting (ADF) plus exercise, ADF alone, exercise alone, or a no-intervention control group. Results showed that intermittent fasting combined with exercise produced significant reductions in body weight and intrahepatic triglyceride content but no changes in sleep quality, duration, insomnia severity, or risk of obstructive sleep apnoea. Authors conclude that 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 obesity and NAFLD.
Abstract
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.
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The Effects of Intermittent Fasting and Continuous Energy Restriction with Exercise on Cardiometabolic Biomarkers, Dietary Compliance, and Perceived Hunger and Mood: Secondary Outcomes of a Randomised, Controlled Trial.
Keenan, S, Cooke, MB, Chen, WS, Wu, S, Belski, R
Nutrients. 2022;14(15)
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Obesity plays an important role in the development of cardiometabolic diseases. Excess body weight contributes to insulin resistance, unfavourable patterns of blood lipids and systemic inflammation, which are significant risk factors for cardiovascular disease and type 2 diabetes. Lifestyle modifications that restrict energy intake are an effective approach to attaining weight loss and reducing fat mass; however, continuous energy restrictions (CER) often have poor compliance in the long run. Intermittent fasting (IF) approaches present a promising alternative to CER and may promote increased compliance. The favourable changes in cardiometabolic health attained by an energy-restricted diet can be further amplified when combined with exercise. This paper is a secondary analysis from a 12-week intervention investigating the effects of a twice-weekly fast (5:2 IF; IFT group) and CER (CERT group) in 34 young, overweight but metabolically healthy participants when combined with resistance training. The analysis focused on changes in cardiometabolic blood markers, ratings of hunger, mood, energy and compliance as well as the participant's intention to continue with their prescribed diets post-intervention. Both dietary patterns improved blood lipids, namely reductions in total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol over 12 weeks. Reductions in TC and LDL-C were more pronounced in the IFT group. No remarkable differences or changes in triglycerides, the inflammatory marker C-reactive Protein or markers of insulin resistance were seen in either group. Both groups reported high levels of dietary compliance and low levels of hunger, suggesting that both diets are well adhered to in the short to medium term. Some gender-specific differences were seen, but the author was unable to make conclusions due to the small study size. The analysis demonstrated that IF and CER, combined with resistance exercise, can improve some cardiometabolic risk biomarkers in overweight but metabolically healthy adults, independent of weight loss, with greater improvements with IF approaches.
Abstract
(1) Background: Excess weight in the form of adiposity plays a key role in the pathogenesis of cardiometabolic diseases. Lifestyle modifications that incorporate continuous energy restriction (CER) are effective at inducing weight loss and reductions in adiposity; however, prescribing daily CER results in poor long-term adherence. Over the past decade, intermittent fasting (IF) has emerged as a promising alternative to CER that may promote increased compliance and/or improvements in cardiometabolic health parameters independent of weight loss. (2) Methods: This paper presents a secondary analysis of data from a 12-week intervention investigating the effects of a twice-weekly fast (5:2 IF; IFT group) and CER (CERT group) when combined with resistance exercise in 34 healthy participants (17 males and 17 females, mean BMI: 27.0 kg/m2, mean age: 23.9 years). Specifically, changes in cardiometabolic blood markers and ratings of hunger, mood, energy and compliance within and between groups were analysed. Dietary prescriptions were hypoenergetic and matched for energy and protein intake. (3) Results: Both dietary groups experienced reductions in total cholesterol (TC; mean reduction, 7.8%; p < 0.001), low-density lipoprotein cholesterol (LDL-C; mean reduction, 11.1%; p < 0.001) and high-density lipoprotein cholesterol (mean reduction 2.6%, p = 0.049) over the 12 weeks. Reductions in TC and LDL-C were greater in the IFT group after adjustment for baseline levels and change in weight. No significant changes in markers of glucose regulation were observed. Both groups maintained high levels of dietary compliance (~80%) and reported low levels of hunger over the course of the intervention period. (4) Conclusions: Secondary data analysis revealed that when combined with resistance training, both dietary patterns improved blood lipids, with greater reductions observed in the IFT group. High levels of compliance and low reported levels of hunger throughout the intervention period suggest both diets are well tolerated in the short-to-medium term.
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The Effects of Time-Restricted Eating versus Standard Dietary Advice on Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults.
Phillips, NE, Mareschal, J, Schwab, N, Manoogian, ENC, Borloz, S, Ostinelli, G, Gauthier-Jaques, A, Umwali, S, Gonzalez Rodriguez, E, Aeberli, D, et al
Nutrients. 2021;13(3)
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Metabolic syndrome (MS) is a collection of conditions such as obesity, high blood pressure and impaired ability to balance blood sugars, that increase the sufferers risk of diabetes, stroke, and heart disease. Weight loss and lifestyle modifications are the main recommendations to improve MS. Intermittent fasting is a dietary regime that involves restricting the intake of food to certain times of the day, without restricting calories and has been shown in animal and human studies to result in fat loss and an increased ability to balance blood sugars. This randomised control trial of 218 adults over 6 months aimed to firstly determine relationships between eating duration, unprocessed and processed foods, and lifestyle factors on health and secondly to determine if a 12-hour time restricted eating pattern leads to an improvement in MS. The results showed that higher consumption of processed foods was associated with poorer metabolic health. A 12-hour restricted eating pattern resulted in weight loss, whereas individuals on a standard daily eating pattern did not, however differences between the two groups were not significant. Other measures of metabolic health failed to show any differences between the two groups. It was concluded that a 12-hour restricted eating pattern was feasible over 6 months, however further research is needed to assess if a more restricted time would result in greater weight loss. This study could be used by healthcare professionals to understand that a restricted eating pattern may be of benefit to those with MS, however further research would be needed to determine the optimal timeframe.
Abstract
Weight loss is key to controlling the increasing prevalence of metabolic syndrome (MS) and its components, i.e., central obesity, hypertension, prediabetes and dyslipidaemia. The goals of our study were two-fold. First, we characterised the relationships between eating duration, unprocessed and processed food consumption and metabolic health. During 4 weeks of observation, 213 adults used a smartphone application to record food and drink consumption, which was annotated for food processing levels following the NOVA classification. Low consumption of unprocessed food and low physical activity showed significant associations with multiple MS components. Second, in a pragmatic randomised controlled trial, we compared the metabolic benefits of 12 h time-restricted eating (TRE) to standard dietary advice (SDA) in 54 adults with an eating duration > 14 h and at least one MS component. After 6 months, those randomised to TRE lost 1.6% of initial body weight (SD 2.9, p = 0.01), compared to the absence of weight loss with SDA (-1.1%, SD 3.5, p = 0.19). There was no significant difference in weight loss between TRE and SDA (between-group difference -0.88%, 95% confidence interval -3.1 to 1.3, p = 0.43). Our results show the potential of smartphone records to predict metabolic health and highlight that further research is needed to improve individual responses to TRE such as a shorter eating window or its actual clock time.
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Time-restricted eating effects on performance, immune function, and body composition in elite cyclists: a randomized controlled trial.
Moro, T, Tinsley, G, Longo, G, Grigoletto, D, Bianco, A, Ferraris, C, Guglielmetti, M, Veneto, A, Tagliabue, A, Marcolin, G, et al
Journal of the International Society of Sports Nutrition. 2020;17(1):65
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Adequate nutrition is important for elite athletes, as nutrient availability influences energy expenditure, body composition, performance and exercise-induced immune responses. Time-restricted eating (TRE) is a form of intermittent fasting that has received much interest in recent years. Previous research of TRE suggested beneficial effects on performance in untrained individuals, by allowing weight loss whilst maintaining muscle functions. These qualities are of interest for endurance cyclists hence the authors of this study sought to investigate the impact of TRE in elite cyclists. Sixteen under-23 year old, elite cyclists were randomly assigned to eat within a TRE window of 8-hr or 15hr window during a 4-week, high-level endurance training phase. Both groups consumed their full estimated energy needs and markers such as fat and fat-free mass, VO2 max, basal metabolism, blood counts, anabolic hormones and inflammatory markers were measured. As a result, TRE produced weight loss, improved body composition and increased peak power output in relation to body weight without compromising aerobic performance. Furthermore, the TRE pattern proved helpful in mitigating some of the exercise-induced suppressions of the immune system. The authors concluded that TRE could be considered as part of a performance nutrition plan in endurance athletes. Particularly where there is a need to reduce body fat mass or for the management of training-induced depression of the immune system and associated respiratory infection susceptibility. This can be of clinical relevance in the support of endurance athletes.
Abstract
BACKGROUND Although there is substantial interest in intermittent fasting as a dietary approach in active individuals, information regarding its effects in elite endurance athletes is currently unavailable. The present parallel randomized trial investigated the effects of a particular intermittent fasting approach, called time-restricted eating (TRE), during 4 weeks of high-level endurance training. METHODS Sixteen elite under-23 cyclists were randomly assigned either to a TRE group or a control group (ND). The TRE group consumed 100% of its estimated daily energy needs in an 8-h time window (from 10:00 a.m. to 6:00 p.m.) whilst energy intake in the ND group was distributed in 3 meals consumed between 7:00 a.m. and 9:00 p.m. Fat and fat-free mass were estimated by bioelectrical impedance analysis and VO2max and basal metabolism by indirect gas analyzer. In addition, blood counts, anabolic hormones (i.e. free testosterone, IGF-1) and inflammatory markers (i.e. IL-6, TNF-α) were assessed. RESULTS TRE reduced body weight (- 2%; p = 0.04) and fat mass percentage (- 1.1%; p = 0.01) with no change in fat-free mass. Performance tests showed no significant differences between groups, however the peak power output/body weight ratio (PPO/BW) improved in TRE group due to weight loss (p = 0.02). Free testosterone and IGF-1 decreased significantly (p = 0.01 and p = 0.03 respectively) in TRE group. Leucocyte count decreased in ND group (p = 0.02) whilst the neutrophils-to-lymphocytes ratio (NLR) decreased significantly (p = 0.03) in TRE group. CONCLUSIONS Our results suggest that a TRE program with an 8-h feeding window elicits weight loss, improves body composition and increases PPO/BW in elite cyclists. TRE could also be beneficial for reducing inflammation and may have a protective effect on some components of the immune system. Overall, TRE could be considered as a component of a periodized nutrition plan in endurance athletes. TRIAL REGISTRATION This trial was retrospectively registered at clinicaltrials.gov as NCT04320784 on 25 March 2020.
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Three 15-min bouts of moderate postmeal walking significantly improves 24-h glycemic control in older people at risk for impaired glucose tolerance.
DiPietro, L, Gribok, A, Stevens, MS, Hamm, LF, Rumpler, W
Diabetes care. 2013;36(10):3262-8
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The insulin response is known to decline with age, which puts older people at risk of hyperglycaemia after eating. Insulin and exercise stimulate the uptake of glucose into skeletal muscle so exercise could aid insulin in age-related impaired glucose tolerance (IGT). This small randomised controlled trial (RCT) used a multiple crossover design to compare the effect of exercise timing and frequency on glycaemia control in older people. The ten trial subjects were at risk of impaired glucose tolerance (IGT), but were otherwise healthy with an average age of sixty-nine years old. Subjects were housed in whole room calorimeters, fed three standardised meals a day and glucose levels were monitored. Subjects were randomly assigned to walk on a treadmill for either fifteen minutes after each of the three meals, or walk for forty-five minutes either at mid-morning or mid-afternoon. It was found that that both the morning walk and the post-meal walking decreased 24 hour glucose concentration, whilst the afternoon walk had little impact. Post-meal walking was effective at lowering glucose levels after each meal including dinner, where the other exercise protocols were not. The author concluded that the timing of the exercise may be as important, if not more, than volume. Short (15 minute) bouts of post-meal walking could be manageable for older people and appears to be an effective way of controlling post eating hyperglycaemia.
Abstract
OBJECTIVE The purpose of this study was to compare the effectiveness of three 15-min bouts of postmeal walking with 45 min of sustained walking on 24-h glycemic control in older persons at risk for glucose intolerance. RESEARCH DESIGN AND METHODS Inactive older (≥60 years of age) participants (N=10) were recruited from the community and were nonsmoking, with a BMI<35 kg/m2 and a fasting blood glucose concentration between 105 and 125 mg dL(-1). Participants completed three randomly ordered exercise protocols spaced 4 weeks apart. Each protocol comprised a 48-h stay in a whole-room calorimeter, with the first day serving as the control day. On the second day, participants engaged in either 1) postmeal walking for 15 min or 45 min of sustained walking performed at 2) 10:30 a.m. or 3) 4:30 p.m. All walking was on a treadmill at an absolute intensity of 3 METs. Interstitial glucose concentrations were determined over 48 h with a continuous glucose monitor. Substrate utilization was measured continuously by respiratory exchange (VCO2/VO2). RESULTS Both sustained morning walking (127±23 vs. 118±14 mg dL(-1)) and postmeal walking (129±24 vs. 116±13 mg dL(-1)) significantly improved 24-h glycemic control relative to the control day (P<0.05). Moreover, postmeal walking was significantly (P<0.01) more effective than 45 min of sustained morning or afternoon walking in lowering 3-h postdinner glucose between the control and experimental day. CONCLUSIONS Short, intermittent bouts of postmeal walking appear to be an effective way to control postprandial hyperglycemia in older people.