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Impact of Experimentally Induced Cognitive Dietary Restraint on Eating Behavior Traits, Appetite Sensations, and Markers of Stress during Energy Restriction in Overweight/Obese Women.
Morin, I, Bégin, C, Maltais-Giguère, J, Bédard, A, Tchernof, A, Lemieux, S
Journal of obesity. 2018;2018:4259389
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The treatment of obesity has become a public health priority given the negative impact of this condition on physical and mental health. The aim of this study was to compare the effects of energy restriction alone or in combination with induced cognitive dietary restraint (CDR) on eating behaviour traits, appetite sensations, and markers of stress in overweight and obese premenopausal women. The study is a single-blinded randomised clinical study which recruited premenopausal women aged between 26 and 50 years. The participants were randomised to either an energy-restriction-plus-induced CDR condition (CDR+group) or an energy-restriction-without induced CDR condition (CDR−group). Results indicate that inducing CDR in a context of energy restriction had no further effects on eating behaviour traits, appetite sensations, and markers of stress in the short term as well as in the longer term than energy restriction alone. Authors conclude that increasing CDR has no negative impact on factors regulating energy balance in the context of energy restriction.
Abstract
Weight loss has been associated with changes in eating behaviors and appetite sensations that favor a regain in body weight. Since traditional weight loss approaches emphasize the importance of increasing cognitive dietary restraint (CDR) to achieve negative energy imbalance, it is difficult to untangle the respective contributions of energy restriction and increases in CDR on factors that can eventually lead to body weight regain. The present study aimed at comparing the effects of energy restriction alone or in combination with experimentally induced CDR on eating behavior traits, appetite sensations, and markers of stress in overweight and obese women. We hypothesized that the combination of energy restriction and induced CDR would lead to more prevalent food cravings, increased appetite sensations, and higher cortisol concentrations than when energy restriction is not coupled with induced CDR. A total of 60 premenopausal women (mean BMI: 32.0 kg/m2; mean age: 39.4 y) were provided with a low energy density diet corresponding to 85% of their energy needs during a 4-week fully controlled period. At the same time, women were randomized to either a condition inducing an increase in CDR (CDR+ group) or a condition in which CDR was not induced (CRD- group). Eating behavior traits (Three-Factor Eating Questionnaire and Food Craving Questionnaire), appetite sensations (after standardized breakfast), and markers of stress (Perceived Stress Scale; postawakening salivary cortisol) were measured before (T = 0 week) and after (T = 4 weeks) the 4-week energy restriction, as well as 3 months later. There was an increase in CDR in the CDR+ group while no such change was observed in the CDR- group (p=0.0037). No between-group differences were observed for disinhibition, hunger, cravings, appetite sensations, perceived stress, and cortisol concentrations. These results suggest that a slight increase in CDR has no negative impact on factors regulating energy balance in the context of energy restriction.
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Effects of Low Versus Moderate Glycemic Index Diets on Aerobic Capacity in Endurance Runners: Three-Week Randomized Controlled Crossover Trial.
Durkalec-Michalski, K, Zawieja, EE, Zawieja, BE, Jurkowska, D, Buchowski, MS, Jeszka, J
Nutrients. 2018;10(3)
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During athletic performance, adequate amounts of carbohydrates are required to prolong the onset of fatigue. Research on whether the glycaemic index (GI) of ingested carbohydrates effects performance has been explored but has produced equivocal results. The aim of this randomised crossover study was to assess the effect of low- and moderate- GI diets on the aerobic capacity and endurance performance in 21 runners. Participants consumed a low- and moderate- GI, high carbohydrate and nutrient balanced diets for three weeks each with a two-week washout period. Aerobic capacity and body composition were measured at the beginning and end of each diet period through various athletic performance tests. This study found that after a low-GI, high-carbohydrate diet, improvements were seen in time to exhaustion and running performance. Gas exchange was improved by both diets. The low-GI carbohydrate diet helped athletes to maintain a more stable blood glucose concentration during exertion tests. Based on these results the authors suggest considering GI when planning a diet for performance athletes, and also urge further research be completed to better understand the effects of long-term GI diets with regards to exercise performance.
Abstract
The glycemic index (GI) of ingested carbohydrates may influence substrate oxidation during exercise and athletic performance. Therefore, the aim of this study was to assess the effect of low- and moderate-GI three-week diets on aerobic capacity and endurance performance in runners. We conducted a randomized crossover feeding study of matched diets differing only in GI (low vs. moderate) in 21 endurance-trained runners. Each participant consumed both, low- (LGI) and moderate-GI (MGI) high-carbohydrate (~60%) and nutrient-balanced diets for three weeks each. At the beginning and end of each diet, participants had their aerobic capacity and body composition measured and performed a 12-min running test. After LGI, time to exhaustion during incremental cycling test (ICT) and distance covered in the 12-min run were significantly increased. The MGI diet led to an increase in maximal oxygen uptake ( V ˙ O₂max), but no performance benefits were found after the MGI diet. The LGI and MGI diets improved time and workload at gas exchange threshold (GET) during ICT. The results indicate that a three-week high-carbohydrate LGI diet resulted in a small but significant improvement in athletic performance in endurance runners. Observed increase in V ˙ O₂max on MGI diet did not affect performance.
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Effects of Providing High-Fat versus High-Carbohydrate Meals on Daily and Postprandial Physical Activity and Glucose Patterns: a Randomised Controlled Trial.
Parr, EB, Devlin, BL, Callahan, MJ, Radford, BE, Blankenship, JM, Dunstan, DW, Hawley, JA
Nutrients. 2018;10(5)
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The timing of habitual meal consumption and composition is known to be an important factor in health status, particularly for blood glucose regulation. The aim of this randomised crossover study was to assess the effects of altering meal timing and diet composition on postprandial glucose and physical activity levels. Eight overweight or obese men with a sedentary lifestyle completed two 12-day measurement periods including a 7-day habitual period followed by a 5-day experimental period, with an 8-day washout period. The two conditions tested were a high-fat, low carbohydrate diet (HFD) and a high-carbohydrate, low-fat diet (HCD) and participants were instructed to consume meals at standardised times throughout both conditions. Body composition, oxygen consumption and blood glucose were measured at baseline and between each experimental condition. This trial found the provision of meals did not alter overall activity patterns or postprandial activity patterns. The authors observed increased sedentary activity across the day, and identify evening time as an important target for sedentary time to be minimised. Based on these results, the authors suggest that future dietary interventions consider habitual meal consumption and composition to best replicate real-world behaviours.
Abstract
We determined the effects of altering meal timing and diet composition on temporal glucose homeostasis and physical activity measures. Eight sedentary, overweight/obese men (mean ± SD, age: 36 ± 4 years; BMI: 29.8 ± 1.8 kg/m²) completed two × 12-day (12-d) measurement periods, including a 7-d habitual period, and then 5 d of each diet (high-fat diet [HFD]: 67:15:18% fat:carbohydrate:protein versus high-carbohydrate diet [HCD]: 67:15:18% carbohydrate:fat:protein) of three meals/d at ±30 min of 0800 h, 1230 h, and 1800 h, in a randomised order with an 8-d washout. Energy intake (EI), the timing of meal consumption, blood glucose regulation (continuous glucose monitor system (CGMS)), and activity patterns (accelerometer and inclinometer) were assessed across each 12-d period. Meal provision did not alter the patterns of reduced physical activity, and increased sedentary behaviour following dinner, compared with following breakfast and lunch. The HCD increased peak (+1.6 mmol/L, p < 0.001), mean (+0.5 mmol/L, p = 0.001), and total area under the curve (+670 mmol/L/min, p = 0.001), as well as 3-h postprandial meal glucose concentrations (all p < 0.001) compared with the HFD. In overweight/obese males, the provision of meals did not alter physical activity patterns, but did affect glycaemic control. Greater emphasis on meal timing and composition is required in diet and/or behaviour intervention studies to ensure relevance to real-world behaviours.
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Chronic Ketogenic Low Carbohydrate High Fat Diet Has Minimal Effects on Acid-Base Status in Elite Athletes.
Carr, AJ, Sharma, AP, Ross, ML, Welvaert, M, Slater, GJ, Burke, LM
Nutrients. 2018;10(2)
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The low-fat, high-carbohydrate ketogenic diet has recently been applied to the context of elite athletes to observe potential impact on performance and metabolism during exercise and rest. The aim to this study was to assess the effect of a long-term ketogenic diet on the acid-base status in elite athletes, particularly investigating whether sustained diet change caused alterations in overall acid production. Twenty-one athletes were assigned to a high carbohydrate diet, low carbohydrate diet and periodised carbohydrate availability diet for three sustained weeks. Acid-base balance was measured via blood samples at baseline and post-intervention. The main finding of this study was that a sustained ketogenic diet had no influence of acid-base status. Based on these results, the authors conclude that long-term manipulation of macronutrient intake is unlikely to influence acid-base status in this population. It is also noted that elite athletes may have an increased buffering capacity compared with the general population, and that further research should be done in different participant populations.
Abstract
Although short (up to 3 days) exposure to major shifts in macronutrient intake appears to alter acid-base status, the effects of sustained (>1 week) interventions in elite athletes has not been determined. Using a non-randomized, parallel design, we examined the effect of adaptations to 21 days of a ketogenic low carbohydrate high fat (LCHF) or periodized carbohydrate (PCHO) diet on pre- and post-exercise blood pH, and concentrations of bicarbonate (HCO₃-) and lactate (La-) in comparison to a high carbohydrate (HCHO) control. Twenty-four (17 male and 7 female) elite-level race walkers completed 21 days of either LCHF (n = 9), PCHO (n = 7), or HCHO (n = 8) under controlled diet and training conditions. At baseline and post-intervention, blood pH, blood [HCO₃-], and blood [La-] were measured before and after a graded exercise test. Net endogenous acid production (NEAP) over the previous 48-72 h was also calculated from monitored dietary intake. LCHF was not associated with significant differences in blood pH, [HCO₃-], or [La-], compared with the HCHO diet pre- or post-exercise, despite a significantly higher NEAP (mEq·day-1) (95% CI = [10.44; 36.04]). Our results indicate that chronic dietary interventions are unlikely to influence acid-base status in elite athletes, which may be due to pre-existing training adaptations, such as an enhanced buffering capacity, or the actions of respiratory and renal pathways, which have a greater influence on regulation of acid-base status than nutritional intake.
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Digestive Responses to Fortified Cow or Goat Dairy Drinks: A Randomised Controlled Trial.
Milan, AM, Hodgkinson, AJ, Mitchell, SM, Prodhan, UK, Prosser, CG, Carpenter, EA, Fraser, K, Cameron-Smith, D
Nutrients. 2018;10(10)
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Fortification of cow milk was initially intended to increase the available micronutrients to meet the needs of growing toddlers. These products are now used among the adolescent and adult populations for caloric regulation or protein enrichment. The aim of this randomised controlled trial was to examine the digestive and metabolic responses to commercially available fortified milks in 30 young adults. Participants were randomised to consume 500-900 mL of fortified milks with either whole milk cow-protein, whole milk goat-protein, or partially-hydrolysed whey cow-protein fortified milk. Plasma amino acid and hormonal responses were measured at baseline and at 5 hours after ingestion, and bowel transit time and digestive comfort were recorded. This study found whole-cow milk and whole-goat milk had similar protein and digestive responses, whereas partially hydrolysed whey led to delayed gastric emptying and increased insulin levels. Based on these results, the authors recommend further studies be done to address the impact of fortified milk consumption on appetite and protein metabolism.
Abstract
Fortified milk drinks are predominantly manufactured from bovine (cow) sources. Alternative formulations include those prepared with hydrolysed bovine milk proteins or from alternate bovidae species, such as caprine (goat) milk. Currently, there is little data on protein digestive and metabolic responses following ingestion of fortified milk drinks. To examine the digestive and metabolic responses to commercially-available fortified milks, young adults (n = 15 males: 15 females), in a randomised sequence, ingested isonitrogenous quantities of whole cow-protein (WC), whole goat-protein (WG), or partially-hydrolysed whey cow-protein (HC), commercial fortified milks. Plasma amino acid (AA) and hormonal responses were measured at baseline and again at 5 h after ingestion. Paracetamol recovery, breath hydrogen, and subjective digestive responses were also measured. Postprandial plasma AA was similar between WC and WG, while AA appearance was suppressed with HC. Following HC, there was a negative incremental AUC in plasma branched-chain AAs. Further, HC had delayed gastric emptying, increased transit time, and led to exaggerated insulin and GLP-1 responses, in comparison to whole protein formulas. Overall, WC and WG had similar protein and digestive responses with no differences in digestive comfort. Contrastingly, HC led to delayed gastric emptying, attenuated AA appearance, and a heightened circulating insulin response.
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Effects of n-3 fatty acids and exercise on oxidative stress parameters in type 2 diabetic: a randomized clinical trial.
Fayh, APT, Borges, K, Cunha, GS, Krause, M, Rocha, R, de Bittencourt, PIH, Moreira, JCF, Friedman, R, da Silva Rossato, J, Fernandes, JR, et al
Journal of the International Society of Sports Nutrition. 2018;15:18
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An elevated blood glucose level is one of the key metabolic abnormalities associated with complications in type 2 diabetes. Literature shows that individuals with type 2 diabetes have higher inflammatory levels than those with normal blood glucose tolerance. The aim of this study was to examine if omega-3 polyunsaturated fatty acid (PUFA) supplementation can reduce the inflammatory response associated with high-intensity exercise in type 2 diabetic individuals. This was a randomised, double-blind controlled study, which recruited 30 type 2 diabetic men and women aged between 30 and 60 years. Results indicate that after 8 weeks, omega-3 PUFA supplementation diminished the concentration of the total reactive antioxidant potential and triglyceride levels after high intensity exercise, however did not reduce the inflammatory response.
Abstract
BACKGROUND The relationship between diabetes and oxidative stress has been previously reported. Exercise represents a useful non-pharmacological strategy for the treatment in type 2 diabetic (T2DM) patients, but high intensity exercise can induce a transient inflammatory state and increase oxidative stress. Nutritional strategies that may contribute to the reduction of oxidative stress induced by acute exercise are necessary. The aim of this study was to examine if n-3 PUFA supplementation intervention can attenuate the inflammatory response and oxidative stress associated with high intensity exercise in this population. As a primary outcome, lipoperoxidation measurements (TBARS and F2-isoprostanes) were selected. METHODS Thirty T2DM patients, without chronic complications, were randomly allocated into two groups: placebo (gelatin capsules) or n-3 PUFA (capsules containing 180 mg of eicosapentaenoic acid and 120 mg of docosahexaenoic acid). Blood samples were collected fasting before and after 8 weeks supplementation. In the beginning and at the end of protocol, an acute exercise was performed (treadmill), and new blood samples were collected before and immediately after the exercise for measurements of oxidative stress and high-sensitivity C-reactive protein (hs-CRP). RESULTS After the supplementation period, a decrease in triglycerides levels was observed only in n-3 PUFA supplementation group (mean difference and 95% CI of 0.002 (0.000-0.004), p = 0.005). Supplementation also significantly reduced TRAP levels after exercise (mean difference and 95% CI to 9641 (- 20,068-39,351) for - 33,884 (- 56,976 - -10,793), p = 0.004, Cohen's d effect size = 1.12), but no significant difference was observed in n-3 PUFA supplementation group in lipoperoxidation parameters as TBARS (mean difference and 95% CI to - 3.8 (- 10-2.4) for - 2.9 (- 1.6-7.4) or F2-isoprostanes (mean difference and 95% CI -0.05 (- 0.19-0.10) for - 0.02 (- 0.19-0.16), p > 0.05 for both. CONCLUSION PUFA n-3 supplementation reduced triglycerides as well as TRAP levels after exercise, without a significant effect on inflammatory and oxidative stress markers.This study is registered at ClinicalTrials.gov with the registration number of NCT03182712.
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Effect of protein and carbohydrate solutions on running performance and cognitive function in female recreational runners.
Gui, Z, Sun, F, Si, G, Chen, Y
PloS one. 2017;12(10):e0185982
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Research has shown that consuming a carbohydrate-electrolyte solution (CES) during endurance exercise can improve performance, delay fatigue and ameliorate post-exercise cognitive dysfuction when compared with a noncaloric placebo (PLA). The addition of protein to the CES (CPES) has been suggested to increase these benefits however the current data is limited. The aim of this crossover study was to investigate whether the added protein to a CES would improve exercise performance and cognitive function in 11 female recreational marathon runners. Participants were randomised to consume one of the three solutions (CES, CPES or PLA) every 2.5km during a 21km run, with a 28-day interval, and their VO2max and cognitive function were recorded after the run. This study showed that CES improved endurance performance compared with PLA, however adding protein to the CES did not provide any additional performance benefit. The CPES solution did benefit visual motor speed compared to PLA, but no differences were found in the other cognitive function tests.
Abstract
This study compared the effects of a carbohydrate-electrolyte-protein solution (CEPS, 2% protein plus 4% carbohydrate), carbohydrate-electrolyte solution (CES, 6% carbohydrate), and noncaloric sweetened placebo (PLA) on both 21-km running performance and cognitive function. Eleven female recreational endurance runners performed a 21-km time-trial running on three occasions, separated by at least 28 days. In a randomized cross-over design, they ingested CEPS, CES, or PLA at a rate of 150 mL every 2.5 km with no time feedback. A cognitive function test was performed before and after the run. Participants ingested approximately 24 g/h carbohydrate plus 12 g/h protein in CEPS trial, and 36 g/h carbohydrate in CES trial during each 21-km trial. Time to complete the time-trial was slightly shorter (P < 0.05) during CES (129.6 ± 8.8 min) than PLA (134.6 ± 11.5 min), with no differences between CEPS and the other two trials. The CEPS trial showed higher composite of visual motor speed than the PLA trial (P < 0.05). In conclusion, CES feedings might improve 21-km time-trial performance in female recreational runners compared with a PLA. However, adding protein to the CES provided no additional time-trial performance benefit. CEPS feeding during prolonged exercise could benefit visual motor speed compared to PLA alone, but no differences in the performance of the other cognitive function tests were found.
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Effects of Two Years of Calorie Restriction on Aerobic Capacity and Muscle Strength.
Racette, SB, Rochon, J, Uhrich, ML, Villareal, DT, DAS, SK, Fontana, L, Bhapkar, M, Martin, CK, Redman, LM, Fuss, PJ, et al
Medicine and science in sports and exercise. 2017;49(11):2240-2249
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Caloric restriction (CR) has been shown to increase lifespan and delay age-related disease in many species. As a part of the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) study, this particular study aimed to determine whether long-term CR adversely affects aerobic capacity and muscle strength in 218 healthy, nonobese adults. Participants were randomised to 25% CR or control group, and a VO2max treadmill test, knee flexor and extensor strength were all measured at baseline, one year and two years. This study showed that two years of CR without a structured exercise component did not appear to compromise aerobic capacity in healthy nonobese adults.
Abstract
PURPOSE Calorie restriction (CR) improves health span and delays age-related diseases in many species. The multicenter Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) study was the first randomized controlled trial of CR in nonobese humans. The aim of this investigation was to determine the effects of CR on V˙O2max and muscle strength in the CALERIE trial. METHODS Healthy, normal-weight, and mildly overweight women and men (n = 218, mean ± SE age = 37.9 ± 0.5 yr) were randomized to 25% CR or an ad libitum (AL) control condition in a 2:1 allocation (143 CR, 75 AL). V˙O2max was determined with an incremental treadmill test; the strength of the knee flexors and extensors was assessed by dynamometry at baseline, 1 yr, and 2 yr. RESULTS The CR group achieved an average 11.9% ± 0.7% CR during the 2-yr intervention. Body weight decreased in CR (-7.7 ± 0.4 kg), but not AL (+0.2 ± 0.5 kg). Absolute V˙O2max (L·min) decreased at 1 and 2 yr with CR, whereas V˙O2max expressed relative to body mass increased at both time points (1 yr: +2.2 ± 0.4; 2 yr: +1.9 ± 0.5 mL·kg·min) and relative to AL. The CR group increased their treadmill test time and workload at 1 and 2 yr. Strength results in CR were similar, with decreases in absolute flexor and extensor strength, but increases when expressed relative to body mass. No changes were observed for V˙O2max expressed relative to lean body mass or leg lean mass. CONCLUSIONS Two years of modest CR without a structured exercise component did not appear to compromise aerobic capacity in healthy nonobese adults. The clinical implications of the observed changes in V˙O2max and muscle strength will be important to explore in future studies.
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Effects of eight weeks of time-restricted feeding (16/8) on basal metabolism, maximal strength, body composition, inflammation, and cardiovascular risk factors in resistance-trained males.
Moro, T, Tinsley, G, Bianco, A, Marcolin, G, Pacelli, QF, Battaglia, G, Palma, A, Gentil, P, Neri, M, Paoli, A
Journal of translational medicine. 2016;14(1):290
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Time-restricted feeding (TRF) allows subjects to consume ad libitum energy intake within a defined window of time, which means a fasting window of 12–21 h per day is employed. The aim of the present study was to investigate the effects of an isoenergetic TRF protocol on body composition, athletic performance, and metabolic factors during resistance training in healthy resistance trained males. The study enrolled thirty-four resistance-trained males. The participants were randomly assigned to a TRF group (n = 17) or standard diet group (n = 17). Training was standardized for both groups. Results indicate that after 8 weeks, a significant decrease in fat mass was observed in the TRF group, while fat-free mass was maintained in both groups. The same trend was observed for arm and thigh muscle cross-sectional area. Leg press maximal strength increased significantly, but no difference was present between treatments. Authors conclude that TRF can maintain muscle mass, reducing body fat, and reducing inflammation markers and anabolic hormones. This kind of regimen could be adopted by athletes during maintenance phases of training in which the goal is to maintain muscle mass while reducing fat mass.
Abstract
BACKGROUND Intermittent fasting (IF) is an increasingly popular dietary approach used for weight loss and overall health. While there is an increasing body of evidence demonstrating beneficial effects of IF on blood lipids and other health outcomes in the overweight and obese, limited data are available about the effect of IF in athletes. Thus, the present study sought to investigate the effects of a modified IF protocol (i.e. time-restricted feeding) during resistance training in healthy resistance-trained males. METHODS Thirty-four resistance-trained males were randomly assigned to time-restricted feeding (TRF) or normal diet group (ND). TRF subjects consumed 100 % of their energy needs in an 8-h period of time each day, with their caloric intake divided into three meals consumed at 1 p.m., 4 p.m., and 8 p.m. The remaining 16 h per 24-h period made up the fasting period. Subjects in the ND group consumed 100 % of their energy needs divided into three meals consumed at 8 a.m., 1 p.m., and 8 p.m. Groups were matched for kilocalories consumed and macronutrient distribution (TRF 2826 ± 412.3 kcal/day, carbohydrates 53.2 ± 1.4 %, fat 24.7 ± 3.1 %, protein 22.1 ± 2.6 %, ND 3007 ± 444.7 kcal/day, carbohydrates 54.7 ± 2.2 %, fat 23.9 ± 3.5 %, protein 21.4 ± 1.8). Subjects were tested before and after 8 weeks of the assigned diet and standardized resistance training program. Fat mass and fat-free mass were assessed by dual-energy x-ray absorptiometry and muscle area of the thigh and arm were measured using an anthropometric system. Total and free testosterone, insulin-like growth factor 1, blood glucose, insulin, adiponectin, leptin, triiodothyronine, thyroid stimulating hormone, interleukin-6, interleukin-1β, tumor necrosis factor α, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides were measured. Bench press and leg press maximal strength, resting energy expenditure, and respiratory ratio were also tested. RESULTS After 8 weeks, the 2 Way ANOVA (Time * Diet interaction) showed a decrease in fat mass in TRF compared to ND (p = 0.0448), while fat-free mass, muscle area of the arm and thigh, and maximal strength were maintained in both groups. Testosterone and insulin-like growth factor 1 decreased significantly in TRF, with no changes in ND (p = 0.0476; p = 0.0397). Adiponectin increased (p = 0.0000) in TRF while total leptin decreased (p = 0.0001), although not when adjusted for fat mass. Triiodothyronine decreased in TRF, but no significant changes were detected in thyroid-stimulating hormone, total cholesterol, high-density lipoprotein, low-density lipoprotein, or triglycerides. Resting energy expenditure was unchanged, but a significant decrease in respiratory ratio was observed in the TRF group. CONCLUSIONS Our results suggest that an intermittent fasting program in which all calories are consumed in an 8-h window each day, in conjunction with resistance training, could improve some health-related biomarkers, decrease fat mass, and maintain muscle mass in resistance-trained males.
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Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer.
Demark-Wahnefried, W, Nix, JW, Hunter, GR, Rais-Bahrami, S, Desmond, RA, Chacko, B, Morrow, CD, Azrad, M, Frugé, AD, Tsuruta, Y, et al
BMC cancer. 2016;16:61
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There is a strong body of evidence associating obesity and increased risk for more aggressive and progressive cancer. This paper aims to assess the feasibility of a presurgical diet and exercise weight loss intervention in men with newly-diagnosed prostate cancer who elected for prostatectomy. It also aims to explore the intervention’s effects on tumour proliferation rates and other biomarkers. The 3-weeks randomised controlled study included 40 overweight or obese men newly-diagnosed with prostate cancer. Participants in experimental arm were assigned to a healthy energy-restricted diet versus wait-list control arm. All feasibility endpoints were achieved with accrual completed within 2 years, retention of 85%, adherence of 95% and no adverse events. Biologic outcomes were not included in this paper, as biological testing was still ongoing. Authors concluded that this study’s methods and data on feasibility could provide useful framework for the design of future trials. They also highlighted the importance of presurgical trials as a feasible and safe means to assess the impacts of diet and exercise on tumour tissue.
Abstract
BACKGROUND Obesity is associated with tumor aggressiveness and disease-specific mortality for more than 15 defined malignancies, including prostate cancer. Preclinical studies suggest that weight loss from caloric restriction and increased physical activity may suppress hormonal, energy-sensing, and inflammatory factors that drive neoplastic progression; however, exact mechanisms are yet to be determined, and experiments in humans are limited. METHODS We conducted a randomized controlled trial among 40 overweight or obese, newly-diagnosed prostate cancer patients who elected prostatectomy to explore feasibility of a presurgical weight loss intervention that promoted a weight loss of roughly one kg. week(-1) via caloric restriction and physical activity, as well as to assess effects on tumor biology and circulating biomarkers. Measures of feasibility (accrual, retention, adherence, and safety) were primary endpoints. Exploratory aims were directed at the intervention's effect on tumor proliferation (Ki-67) and other tumor markers (activated caspase-3, insulin and androgen receptors, VEGF, TNFβ, NFκB, and 4E-BP1), circulating biomarkers (PSA, insulin, glucose, VEGF, TNFβ, leptin, SHBG, and testosterone), lymphocytic gene expression of corresponding factors and cellular bioenergetics in neutrophils, and effects on the gut microbiome. Consenting patients were randomized in a 1:1 ratio to either: 1) weight loss via a healthful, guidelines-based diet and exercise regimen; or 2) a wait-list control. While biological testing is currently ongoing, this paper details our methods and feasibility outcomes. RESULTS The accrual target was met after screening 101 cases (enrollment rate: 39.6%). Other outcomes included a retention rate of 85%, excellent adherence (95%), and no serious reported adverse events. No significant differences by age, race, or weight status were noted between enrollees vs. non-enrollees. The most common reasons for non-participation were "too busy" (30%), medical exclusions (21%), and "distance" (16%). CONCLUSIONS Presurgical trials offer a means to study the impact of diet and exercise interventions directly on tumor tissue, and other host factors that are feasible and safe, though modifications are needed to conduct trials within an abbreviated period of time and via distance medicine-based approaches. Pre-surgical trials are critical to elucidate the impact of lifestyle interventions on specific mechanisms that mediate carcinogenesis and which can be used subsequently as therapeutic targets. TRIAL REGISTRATION NCT01886677.