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Effects of combined dietary intervention and physical-cognitive exercise on cognitive function and cardiometabolic health of postmenopausal women with obesity: a randomized controlled trial.
Keawtep, P, Sungkarat, S, Boripuntakul, S, Sa-Nguanmoo, P, Wichayanrat, W, Chattipakorn, SC, Worakul, P
The international journal of behavioral nutrition and physical activity. 2024;(1):28
Abstract
BACKGROUND Postmenopausal women with obesity are markedly at risk of cognitive impairment and several health issues. Emerging evidence demonstrated that both diet and exercise, particularly physical-cognitive exercise are involved in cognitive and health benefits. However, the comparative effect of diet, exercise, and combined interventions in postmenopausal women with obesity on cognition and cardiometabolic health is still lacking. Identifying the effective health promotion program and understanding changes in cardiometabolic health linking these interventions to cognition would have important medical implications. This RCT aimed to examine the effect of single and combined interventions of diet and exercise on cognitive function and cardiometabolic health in postmenopausal women with obesity. METHODS Ninety-two postmenopausal women with obesity were randomly assigned to diet group (intermittent fasting 2 days/week, 3 months), exercise group (physical-cognitive exercise 3 days/week, 3 months), combined group, or control group (n = 23/group). All cognitive outcomes and cardiometabolic outcomes were measured at baseline and post-3 months. Primary outcomes were executive functions, memory, and plasma BDNF levels. Secondary outcomes were global cognition, attention, language domain, plasma adiponectin levels, IL-6 levels, metabolic parameters, and physical function. RESULTS At the end of the 3-month intervention, the exercise and combined group demonstrated significant memory improvement which was accompanied by significant improvements in plasma BDNF level, insulin levels, HOMA-IR, %body fat, and muscle strength when compared to controls (p < 0.05). Only the combined intervention group demonstrated a significant improvement in executive function and increased plasma adiponectin levels when compared to control (p < 0.05). Surprisingly, no cognitive improvement was observed in the diet group (p > 0.05). Significant reduction in cholesterol levels was shown in the diet and combined groups when compared to controls (p < 0.05). Among the three intervention groups, there were no significant differences in all cognitive outcomes and cardiometabolic outcomes (p > 0.05). However, all three intervention groups showed significant improvements in plasma BDNF levels, weight, BMI, WHR, fat mass, and predicted VO2 max, when compared to control (p < 0.05). CONCLUSION These findings suggest that combined physical-cognitive exercise and dietary intervention are promising interventions to improve cognition and obesity-related complications of postmenopausal women with obesity. TRIAL REGISTRATION NCT04768725 ( https://clinicaltrials.gov ) 24th February 2021.
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Promotion of Successful Weight Management in Overweight and Obese Veterans (POWER-VET): Trial Design and Methods.
Serra, MC, Ortmeyer, HK, Ryan, AS, ,
Contemporary clinical trials. 2024;:107412
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BACKGROUND Almost 75% of US adults are overweight or obese. Though intentional weight loss of as little as 3% improves physical functioning and reduces cardiometabolic risk, most adults are unsuccessful at long-term weight maintenance. Our hypothesis is that intermittent fasting (IF: short periods of intense energy restriction) will reduce weight regain. IF may combat obesity due to its effects on nutrient-sensing signaling pathways and circadian rhythm. The objective of this randomized clinical trial is to test the effectiveness of an intensive body weight management program with and without IF. METHODS In the Promotion of Successful Weight Management in Overweight and Obese Veterans (POWER-VET) trial (NCT04131647), 154 middle-aged and older adults (50-75 years) who are overweight and obese (BMI: 25-40 kg/m2) and seen at either a Baltimore, MD or San Antonio, TX Veterans Affairs Medical Center will be enrolled. Participants will undergo 12 weeks of weight loss (including a low-calorie heart healthy (HH) diet and exercise). Following weight loss, participants will be randomly assigned to one of two 24-week weight maintenance (WM) interventions: WM alone (continuation of HH diet and exercise) or WM + IF. The primary aim is to determine the effect of WM + IF compared to WM alone on body weight maintenance after intentional weight loss. DISCUSSION Determining effective, translatable strategies that minimize weight regain following successful weight loss holds public health relevance. This POWER-VET trial introduces an innovative practice of IF to prevent weight regain after clinically significant weight reduction and could provide evidence-based recommendations to promote this type of intervention in middle aged and older adults.
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Lifestyle Intervention With Smartphone App and isCGM for People at High Risk of Type 2 Diabetes: Randomized Trial.
Kitazawa, M, Takeda, Y, Hatta, M, Horikawa, C, Sato, T, Osawa, T, Ishizawa, M, Suzuki, H, Matsubayashi, Y, Fujihara, K, et al
The Journal of clinical endocrinology and metabolism. 2024;(4):1060-1070
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AIMS: Although conventional interventions for people at high risk of developing type 2 diabetes are usually conducted face-to-face, such interventions are burdensome for health care providers. We developed a lifestyle intervention program combining lifestyle coaching via a smartphone application augmented by intermittently scanned continuous glucose monitoring without burdening health care providers. Its effectiveness for glycemic control and body weight reduction in people at risk of type 2 diabetes was investigated. MATERIALS AND METHODS For this 12-week randomized unblinded trial with offline recruitment, participants with a hemoglobin A1c level of 5.6% to 6.4% or a fasting blood glucose of 110 to 125 mg/dL and body mass index (BMI) >23 kg/m2 but <40 kg/m2 were randomly assigned to the intervention group (App) and control group (C). The primary endpoint was the difference in time in range of blood glucose between 70 and 140 mg/dL (3.9-7.8 mmol/L) before and after the study period between the 2 groups. RESULTS Among 168 patients (mean age, 48.1 years; mean BMI, 26.6 kg/m2; and male, 80.4%), 82 and 86 were assigned to the App group and C group, respectively. After 12 weeks, time in range of blood glucose at 70 to 140 mg/dL significantly improved in the App group compared with the C group (-2.6 minutes/day vs +31.5 minutes/day, P = .03). Changes in time above range did not differ, whereas time below range (blood glucose <70 mg/dL; +23.5 minutes/day vs -8.9 minutes/day, P = .02) improved in the App group. BMI (-0.26 vs -0.59, P = .017) was reduced in the App group compared with the C group. CONCLUSION Intervention with a smartphone app and intermittently scanned continuous glucose monitoring increased glycemic control accompanied by decreased carbohydrate intake and weight loss. Further trials are needed to confirm whether these interventions can reduce incident type 2 diabetes.
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[TEN-HOUR INTERMITTENT FASTING PLUS MEDITERRANEAN DIET VERSUS MEDITERRANEAN DIET ALONE FOR TREATMENT OF NONALCOHOLIC FATTY LIVER DISEASE (NAFLD)].
Milgrom, Y, Massarwa, M, Hazou, W, Shafrir, A, Mishraki, E, Sanduka, S, Safadi, R, Benson, A
Harefuah. 2024;(2):93-96
Abstract
INTRODUCTION Nonalcoholic Fatty Liver Disease (NAFLD) has become the leading cause of liver morbidity. The Mediterranean diet can improve NAFLD and may be offered as treatment. Intermittent fasting has been shown to improve aspects of the metabolic syndrome, but its effect on NAFLD is inconclusive. OBJECTIVES A randomized - controlled study assessed the outcomes of the effect of the Mediterranean diet alone versus the Mediterranean diet in combination with intermittent fasting for 16 weeks in patients with NAFLD (1:2 ratio) and subsequent long term follow-up. Outcomes parameters included the response to treatment as measured by body mass index (height and weight), waist-hip ratio, and levels of steatosis and fibrosis as measured by transient elastography. In addition, satisfaction and compliance were assessed via questionnaires (ten-point Likert scale). RESULTS Sixteen out of 40 recruited patients completed the study (69% men, mean age 45.8 ± 12.1 years, mean baseline BMI 33 ± 4.5), of which nine patients were included in the arm of diet in combination with intermittent fasting. The two groups were similar at baseline with regard to age, gender, height, weight, BMI, waist to hip ratio, and levels of steatosis and fibrosis. At the study end, a significant decrease was observed (p-value = 0.01) in the degree of steatosis from 316.4 ± 50.4 to 279 ± 35.7 DB/m. The improvement in steatosis was significant (p-value = 0.01) in the intermittent fasting group (an improvement of 13.8 ± 20.9%) as compared to the group without intermittent fasting (4.2 ± 20.9%, no statistical significance). The other physical outcome measures did not show a statistically significant change between values at the beginning of the study and study end (16 weeks). Participant questionnaires were completed at a mean follow-up of 1.6 ± 0.2 years and showed a high level (8.3 ± 1.69) of compliance at the beginning of the study in both groups. In addition, both study groups expressed a similar degree of difficulty in adhering to the assigned diet. By study end, participant adherence was significantly higher (p-value = 0.04) among the Mediterranean diet group alone (7 ± 2) as compared to the group in combination with intermittent fasting (4.9 ± 2). Furthermore, those in the Mediterranean diet alone group were more willing (9.7 ± 0.8) to continue the dietary treatment after completing the study as compared to the intermittent fasting group (6.4 ± 0.7) (p-value = 0.03). Study participants in both groups reported that their dietary treatment was overall beneficial (7.9 ± 2.2). CONCLUSIONS This study, given the limitations of a small sample size, suggests that a Mediterranean diet in combination with intermittent fasting improves steatosis in NAFLD patients over the long term as compared to Mediterranean diet without time restricted eating.
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Intermittent feeding with an overnight fast versus 24-h feeding in critically ill neonates, infants, and children: An open-label, single-centre, randomised controlled trial.
Veldscholte, K, Cramer, ABG, de Jonge, RCJ, Rizopoulos, D, Joosten, KFM, Verbruggen, SCAT
Clinical nutrition (Edinburgh, Scotland). 2023;(9):1569-1580
Abstract
BACKGROUND & AIMS Critically ill children are fed day and night, assuming this improves enteral tolerance and the probability of achieving nutritional goals. It was previously shown that a fasting response, reflected by increased ketosis, at least partly explained the beneficial outcome of delayed initiation of supplemental parenteral nutrition. This study aims to investigate whether an overnight fast increases ketosis and is feasible and safe in critically ill children. METHODS The Continuousversus Intermittent Nutrition in Paediatric Intensive Care (ContInNuPIC) study is a randomised controlled trial in a tertiary referral Paediatric Intensive Care Unit (PICU) in the Netherlands. Critically ill children (term newborn-18 years) with an expected PICU stay ≥48 h, dependent on artificial nutrition, were eligible. Participants were randomly assigned (1:1, stratified for age group) to intermittent feeding, with interruption of feedings during an age-dependent overnight period of eight to 12 h, or to continuous feeding, with the administration of feedings day and night. In both groups, similar daily caloric targets were pursued. For children younger than one year, mandatory minor glucose infusions were provided during fasting. The primary outcome was the feasibility, defined as two conditions (1): a significant difference in the patients' highest daily ketone (3-β-hydroxybutyrate, BHB) levels during each overnight period, and (2): non-inferiority regarding daily caloric intake, examined using a two-part mixed-effects model with a predefined non-inferiority margin of 33%, in an intention-to-treat analysis. The study is registered in the Netherlands Trial Register (NL7877). RESULTS Between May 19, 2020, and July 13, 2022, 140 critically ill children, median (first quartile; third quartile) age 0.3 (0.1; 2.7) years, were randomised to intermittent (n = 67) or continuous feeding (n = 73). In the intermittent feeding group, BHB levels were significantly higher (median 0.4 (0.2; 1.0) vs. 0.3 (0.1; 0.7) mmol/L, p < 0.001). The ratio of total caloric intake in the intermittent feeding group to the intake in the continuous feeding group was not consistently significantly more than 0.67, thus not proving non-inferiority. No severe, resistant hypoglycaemic events, nor severe gastrointestinal complications related to the intervention occurred, and feeding intolerance did not occur more often in the intermittent than in the continuous feeding group. CONCLUSION Compared with day and night feeding, intermittent feeding with an overnight fast and mandatory glucose infusion for children younger than one year marginally increased ketosis and did not lead to more hypoglycaemic incidents in critically ill children. Because non-inferiority regarding daily caloric intake was not proven, the feasibility of an overnight fast could not be shown in the current study. However, as feeding intolerance did not increase during the condensed feeding periods, the nutritional intake was probably limited by the prescription of nutrition and interruptions. More research is needed to determine the optimal level and duration of clinically relevant ketosis and the best method to achieve this.
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Intermittent dietary carbohydrate restriction versus calorie restriction and cardiometabolic profiles: A randomized trial.
Dou, Y, Jiang, Y, Chen, X, Zhang, Y, Wang, Y, Chen, H, He, W, Yan, W
Obesity (Silver Spring, Md.). 2023;(9):2260-2271
Abstract
OBJECTIVE The aim of this study was to investigate the effectiveness of an intermittent low-carbohydrate diet (ILCD) versus calorie restriction (ICR) in young populations and potential mechanisms. METHODS Thirty-four participants aged 9 to 30 years with cardiometabolic risk were randomized to receive a self-administered 2-week ILCD (carbohydrate intake ≤ 50 g/d on seven nonconsecutive days) or ICR (500-600 kcal/d for two consecutive days per week). Differences in changes in obesity measures, glycemic and lipid profiles, gut microbiota composition, and three serum biomarkers were compared. RESULTS The ILCD and ICR similarly reduced body weight, waist circumference, fasting glucose, insulin, postprandial glucose variation, monocyte chemoattractant protein-1, free fatty acid, and fibroblast growth factor 21, whereas ILCD produced significantly different alterations in the following outcomes compared with ICR: greater increases in low-density lipoprotein cholesterol and total cholesterol (-0.36 mmol/L, 95% CI: -0.68 to -0.04; -0.40 mmol/L, 95% CI: -0.73 to -0.06) and greater decrease in triglyceride (0.20 mmol/L, 95% CI: 0.04 to 0.37). Actinobacteria and Bifidobacterium reduced after ILCD but not ICR; and the reductions strongly correlated with changes in fasting glucose (both r = 0.84) and low-density lipoprotein cholesterol (r = -0.81 and -0.72). CONCLUSIONS This study found no evidence of differences in changes from baseline in obesity measures, glucose regulation, and inflammation between ILCD and ICR, despite trends in reduction in those parameters. However, there seemed to be some differences in responses in lipids and gut microbiota.
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Intermittent fasting plus early time-restricted eating versus calorie restriction and standard care in adults at risk of type 2 diabetes: a randomized controlled trial.
Teong, XT, Liu, K, Vincent, AD, Bensalem, J, Liu, B, Hattersley, KJ, Zhao, L, Feinle-Bisset, C, Sargeant, TJ, Wittert, GA, et al
Nature medicine. 2023;(4):963-972
Abstract
Intermittent fasting appears an equivalent alternative to calorie restriction (CR) to improve health in humans. However, few trials have considered applying meal timing during the 'fasting' day, which may be a limitation. We developed a novel intermittent fasting plus early time-restricted eating (iTRE) approach. Adults (N = 209, 58 ± 10 years, 34.8 ± 4.7 kg m-2) at increased risk of developing type 2 diabetes were randomized to one of three groups (2:2:1): iTRE (30% energy requirements between 0800 and 1200 hours and followed by a 20-h fasting period on three nonconsecutive days per week, and ad libitum eating on other days); CR (70% of energy requirements daily, without time prescription); or standard care (weight loss booklet). This open-label, parallel group, three-arm randomized controlled trial provided nutritional support to participants in the iTRE and CR arms for 6 months, with an additional 12-month follow-up. The primary outcome was change in glucose area under the curve in response to a mixed-meal tolerance test at month 6 in iTRE versus CR. Glucose tolerance was improved to a greater extent in iTRE compared with CR (-10.10 (95% confidence interval -14.08, -6.11) versus -3.57 (95% confidence interval -7.72, 0.57) mg dl-1 min-1; P = 0.03) at month 6, but these differences were lost at month 18. Adverse events were transient and generally mild. Reports of fatigue were higher in iTRE versus CR and standard care, whereas reports of constipation and headache were higher in iTRE and CR versus standard care. In conclusion, incorporating advice for meal timing with prolonged fasting led to greater improvements in postprandial glucose metabolism in adults at increased risk of developing type 2 diabetes. ClinicalTrials.gov identifier NCT03689608 .
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How Attention Changes in Response to Carbohydrate Mouth Rinsing.
Hosang, TJ, Laborde, S, Löw, A, Sprengel, M, Baum, N, Jacobsen, T
Nutrients. 2023;(13)
Abstract
Research investigating the effects of carbohydrate (CHO) mouth rinsing on neurocognitive functions is currently limited and has yielded inconsistent results. In this study, we employed the event-related potential (ERP) electroencephalography technique to investigate the effect of CHO mouth rinsing on electrophysiological correlates of visuospatial attention. Using a double-blind, non-nutritive sweetener (NNS)-controlled, within-subjects design, 53 young adults performed a standard cognitive task (modified Simon task) on two separate days in a fasted state (16 h). Intermittently, mouth rinsing was performed either with a CHO (glucose, 18%, 30 mL) or an NNS solution (aspartame, 0.05%, 30 mL). Results revealed that relative to NNS, electrophysiological correlates of both more bottom-up controlled visuospatial attention (N1pc-ERP component) were decreased in response to CHO rinsing. In contrast, compared to NNS, more top-down controlled visuospatial attention (N2pc-ERP component) was increased after CHO rinsing. Behavioral performance, however, was not affected by mouth rinsing. Our findings suggest that orosensory signals can impact neurocognitive processes of visuospatial attention in a fasted state. This may suggest a central mechanism underlying the ergogenic effects of carbohydrate mouth rinsing on endurance performance could involve modulations of attentional factors. Methodologically, our study underlines that understanding the effects of carbohydrate mouth rinsing at the central level may require combining neuroscientific methods and manipulations of nutritional states.
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A patient perspective on applying intermittent fasting in gynecologic cancer.
Redding, A, Santarossa, S, Murphy, D, Udumula, MP, Munkarah, A, Hijaz, M, Rattan, R
BMC research notes. 2023;(1):190
Abstract
OBJECTIVE Researchers sought patient feedback on a proposed randomized controlled trial (RCT) in which gynecological cancer patients would modify their diets with intermittent fasting to gain insight into patients' perspectives, receptivity, and potential obstacles. A convenience sample of 47 patients who met the inclusion criteria of the proposed RCT provided their feedback on the feasibility and protocols of the RCT using a multi-method approach consisting of focus groups (n = 8 patients) and surveys (n = 36 patients). RESULTS Patients were generally receptive to the concept of intermittent fasting, and many expressed an interest in attempting it themselves. Patients agreed that the study design was feasible in terms of study assessments, clinic visits, and biospecimen collection. Feedback on what could facilitate adherence included convenient appointment scheduling times and the availability of the research team to answer questions. Regarding recruitment, patients offered suggestions for study advertisements, with the majority concurring that a medical professional approaching them would increase their likelihood of participation.
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Effect of alternate day fasting combined with aerobic exercise on non-alcoholic fatty liver disease: A randomized controlled trial.
Ezpeleta, M, Gabel, K, Cienfuegos, S, Kalam, F, Lin, S, Pavlou, V, Song, Z, Haus, JM, Koppe, S, Alexandria, SJ, et al
Cell metabolism. 2023;(1):56-70.e3
Abstract
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.