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1.
The Effect of Ramadan Fasting on Body Composition and Metabolic Syndrome in Apparently Healthy Men.
Al-Barha, NS, Aljaloud, KS
American journal of men's health. 2019;(1):1557988318816925
Abstract
There are few studies investigating the role of Ramadan fasting on body composition and the characteristics of metabolic syndrome, especially in hot environments. The main aim of the study was to investigate the effect of Ramadan fasting on body composition and the characteristics of metabolic syndrome in apparently healthy men. In a randomized design, 44 college students aged 27.6 ± 5.8 years were selected to participate in the present study. Lifestyle was assessed by a developed questionnaire, body composition was measured using a bioelectrical impedance analyzer, and blood parameters were evaluated by taking a vein blood sample (10 ml) after fasting 10 hr. All measurements were taken 2-3 days before the month of Ramadan, at the end of Week 2 and end of Week 3, and 6 weeks later. The results identified no significant changes in any of the body composition parameters before, during, or after the month of Ramadan. The only significant change in blood parameters was recorded as a positive reduction in low-density lipoprotein (LDL) during the month of Ramadan, compared to before and after Ramadan. No major changes in metabolic syndrome factors were seen except in fasting blood glucose and systolic blood pressure as both factors were slightly but significantly elevated during the month of Ramadan and even after Ramadan, though both of them were within normal levels. This study concludes that Ramadan fasting could be one of the factors that reduce LDL. More studies are needed to clarify the role of Ramadan fasting on different populations such as obese and diabetic patients.
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2.
Modest changes to glycemic regulation are sufficient to maintain glucose fluxes in healthy young men following overfeeding with a habitual macronutrient composition.
Morrison, DJ, Kowalski, GM, Bruce, CR, Wadley, GD
American journal of physiology. Endocrinology and metabolism. 2019;(6):E1061-E1070
Abstract
Currently, it is unclear whether short-term overfeeding in healthy people significantly affects postprandial glucose regulation, as most human overfeeding studies have utilized induced experimental conditions such as the euglycemic-hyperinsulinemic clamp technique to assess glucoregulation. The aim of this study was to quantify glucose fluxes [rates of meal glucose appearance (Ra), disposal (Rd), and endogenous glucose production (EGP)] in response to 5 and 28 days of overfeeding (+45% energy) while maintaining habitual macronutrient composition (31.0 ± 1.9% fat, 48.6 ± 2.2% carbohydrate, 16.7 ± 1.4% protein) in healthy, lean young men. Meal tolerance testing was combined with the triple-stable isotope glucose tracer approach. Visceral adipose volume increased by ~15% with 5 days of overfeeding, while there was no further change at 28 days. In contrast, body mass (+1.6 kg) and fat mass (+1.3 kg) were significantly increased only after 28 days of overfeeding. Fasting EGP, Rd, and insulin were increased at 5 but unchanged after 28 days. Postprandial glucose and insulin responses were unaltered by 5 days of overfeeding but were modestly increased after 28 days (P < 0.05). However, meal Ra and glucose Rd were significantly increased after both 5 and 28 days of overfeeding (P < 0.05). Despite this, overfeeding did not lead to alterations to postprandial EGP suppression. Thus, in contrast to findings from euglycemic-hyperinsulinemic clamp studies, chronic overfeeding did not affect the ability to suppress EGP or stimulate Rd under postprandial conditions. Rather, glucose flux was appropriately maintained following 28 days of overfeeding through modest increases in postprandial glycemia and insulinemia.
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3.
PBPK Absorption Modeling of Food Effect and Bioequivalence in Fed State for Two Formulations with Crystalline and Amorphous Forms of BCS 2 Class Drug in Generic Drug Development.
Rebeka, J, Jerneja, O, Igor, L, Boštjan, P, Aleksander, B, Simon, Ž, Albin, K
AAPS PharmSciTech. 2019;(2):59
Abstract
Prediction of the effect of food on drug's pharmacokinetics using modeling and simulation could cause difficulties due to complex in vivo processes. A generic formulation with amorphous form of BCS 2 class drug substance was developed and compared in vitro and in vivo to the reference drug product with drug substance in crystalline form. In order to approve generic formulation, some regulatory agencies are requesting to perform bioequivalence (BE) studies also in fed state. Food can have various effects on drug dissolution and absorption, depending also on drug's properties. A physiologically based pharmacokinetic (PBPK) absorption model was built in GastroPlus™ to predict the food effect on generic and reference formulation and to predict the fed BE study outcome. During model development, we were searching for model inputs that impact and describe in vivo behavior of amorphous and crystalline forms of active pharmaceutical ingredient (API) in fast and fed conditions. The developed model was able to predict the food effect with up to 10% prediction error (PE). Performed virtual BE trials confirmed the BE of drug products in fed state. Our model was able to capture the difference between the two drug products containing different forms of API (amorphous and crystalline) and predict the food effect on both formulations.
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4.
Influence of pre-operative oral carbohydrate loading vs. standard fasting on tumor proliferation and clinical outcome in breast cancer patients ─ a randomized trial.
Lende, TH, Austdal, M, Varhaugvik, AE, Skaland, I, Gudlaugsson, E, Kvaløy, JT, Akslen, LA, Søiland, H, Janssen, EAM, Baak, JPA
BMC cancer. 2019;(1):1076
Abstract
BACKGROUND Conflicting results have been reported on the influence of carbohydrates in breast cancer. OBJECTIVE To determine the influence of pre-operative per-oral carbohydrate load on proliferation in breast tumors. DESIGN Randomized controlled trial. SETTING University hospital with primary and secondary care functions in South-West Norway. PATIENTS Sixty-one patients with operable breast cancer from a population-based cohort. INTERVENTION Per-oral carbohydrate load (preOp™) 18 and 2-4 h before surgery (n = 26) or standard pre-operative fasting with free consumption of tap water (n = 35). MEASUREMENTS The primary outcome was post-operative tumor proliferation measured by the mitotic activity index (MAI). The secondary outcomes were changes in the levels of serum insulin, insulin-c-peptide, glucose, IGF-1, and IGFBP3; patients' well-being, and clinical outcome over a median follow-up of 88 months (range 33-97 months). RESULTS In the estrogen receptor (ER) positive subgroup (n = 50), high proliferation (MAI ≥ 10) occurred more often in the carbohydrate group (CH) than in the fasting group (p = 0.038). The CH group was more frequently progesterone receptor (PR) negative (p = 0.014). The CH group had a significant increase in insulin (+ 24.31 mIE/L, 95% CI 15.34 mIE/L to 33.27 mIE/L) and insulin c-peptide (+ 1.39 nM, 95% CI 1.03 nM to 1.77 nM), but reduced IGFBP3 levels (- 0.26 nM; 95% CI - 0.46 nM to - 0.051 nM) compared to the fasting group. CH-intervention ER-positive patients had poorer relapse-free survival (73%) than the fasting group (100%; p = 0.012; HR = 9.3, 95% CI, 1.1 to 77.7). In the ER-positive patients, only tumor size (p = 0.021; HR = 6.07, 95% CI 1.31 to 28.03) and the CH/fasting subgrouping (p = 0.040; HR = 9.30, 95% CI 1.11 to 77.82) had independent prognostic value. The adverse clinical outcome of carbohydrate loading occurred only in T2 patients with relapse-free survival of 100% in the fasting group vs. 33% in the CH group (p = 0.015; HR = inf). The CH group reported less pain on days 5 and 6 than the control group (p < 0.001) but otherwise exhibited no factors related to well-being. LIMITATION Only applicable to T2 tumors in patients with ER-positive breast cancer. CONCLUSIONS Pre-operative carbohydrate load increases proliferation and PR-negativity in ER-positive patients and worsens clinical outcome in ER-positive T2 patients. TRIAL REGISTRATION CliniTrials.gov; NCT03886389. Retrospectively registered March 22, 2019.
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5.
Performance evaluation of a self-administered home oral glucose tolerance test kit in a controlled clinical research setting.
Dunseath, GJ, Bright, D, Jones, C, Dowrick, S, Cheung, WY, Luzio, SD
Diabetic medicine : a journal of the British Diabetic Association. 2019;(7):862-867
Abstract
AIM: To evaluate the performance of the current, pre-production version of a novel home oral glucose tolerance test (Home OGTT) device when administered by trained research nurses, compared with a reference laboratory glucose analyser and a second laboratory analyser, incorporating a sample processing delay to simulate normal practice. METHODS One hundred women (aged 19-48 years), with and without known glucose intolerance were recruited. Following an overnight fast, participants attended for a 75-g OGTT. A fasting capillary sample was applied to the Home OGTT device with a corresponding venous sample collected and measured immediately on the reference YSI 2300 stat plus analyser, and following a 1-h delay on the Randox Daytona Plus analyser. The sampling process was repeated 2 h after the oral glucose load. RESULTS Some 97% of tested devices gave complete data for analysis. Good agreement was observed between the reference glucose analyser and the Home OGTT device, with the Home OGTT device displaying a small negative bias (-0.18 mmol/l, -1.75 to 1.39 mmol/mol; -1.0%, -26.4% to 24.5%; absolute and relative mean, 95% limits of agreement). When classified as normal glucose tolerant or glucose intolerant, the Home OGTT device showed 100% and 90% sensitivity, and 99% and 99% specificity using fasting plasma glucose and 2-h glucose respectively. Similar sensitivity (100% and 100%) and specificity (96% and 99%) for fasting plasma glucose and 2-h glucose were observed using the secondary analyser. CONCLUSIONS The novel Home OGTT device was reliable and easy to use and showed excellent agreement with two separate laboratory analysers. The Home OGTT offers potential as an effective alternative for clinic-based OGTT testing.
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6.
Diurnal influences of fasted and non-fasted brisk walking on gastric emptying rate, metabolic responses, and appetite in healthy males.
McIver, VJ, Mattin, LR, Evans, GH, Yau, AMW
Appetite. 2019;:104411
Abstract
Growing evidence suggests circadian rhythms, nutrition and metabolism are intimately linked. Intermittent fasting (IMF) has become an increasingly popular intervention for metabolic health and combining IMF with exercise may lead to benefits for weight management. However, little is known about the diurnal variation of fasted exercise. This study aimed to investigate the diurnal influences on gastric emptying rate (GER), metabolic responses, and appetite to fasted and non-fasted exercise. Twelve healthy males completed four 45 min walks in a randomised order. Walks were completed in the morning (AM) and evening (PM) and either fasted (FASTED) or after consumption of a standardised meal (FED). GER of a semi-solid lunch was subsequently measured for 2 h using the 13C breath test. Blood glucose concentration, substrate utilisation, and ratings of appetite were measured throughout. Energy intake was also assessed for the following 24 h. GER Tlag was slower in PM-FASTED compared to AM-FASTED, AM-FED, and PM-FED (75 ± 18 min vs. 63 ± 14 min, P = 0.001, vs. 65 ± 10 min, P = 0.028 and vs. 67 ± 16 min, P = 0.007). Blood glucose concentration was greater in the FED trials in comparison to the FASTED trials pre-lunch (P < 0.05). Fat oxidation was greater throughout exercise in both FASTED trials compared to FED, and remained higher in FASTED trials than fed trials post-exercise until 30 min post-lunch ingestion (all P < 0.05). No differences were found for appetite post-lunch (P > 0.05) or 24 h post-energy intake (P = 0.476). These findings suggest that evening fasted exercise results in delayed GER, without changes in appetite. No compensatory effects were observed for appetite, and 24 h post-energy intake for both fasted exercise trials, therefore, increased fat oxidation holds positive implications for weight management.
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7.
Effects of Ramadan intermittent fasting on lipid and lipoprotein parameters: An updated meta-analysis.
Mirmiran, P, Bahadoran, Z, Gaeini, Z, Moslehi, N, Azizi, F
Nutrition, metabolism, and cardiovascular diseases : NMCD. 2019;(9):906-915
Abstract
AIMS: This systematic review and meta-analysis aimed to clarify several aspects of intermittent fasting during the month of Ramadan on lipid and lipoprotein levels in apparently healthy subjects. DATA SYNTHESIS We searched PubMed, Scopus, and Embase databases and the reference lists of previous reviews, up to Feb 2019 for studies that investigated the effects of Ramadan fasting on fasting levels of triglycerides (TG), total cholesterol (TC), HDL-C, LDL-C, and VLDL-C among healthy subjects including pregnant women and athletic subjects. Studies were selected for quality assessment, meta-analyses, subgroup analyses, and meta-regressions; data of 33 eligible studies, conducted between 1978 and 2019, were included in the analysis. RESULTS Intermittent fasting showed no significant effect on circulating TG (WMD = -0.38 mg/dl, 95% CI = -5.33, 4.57), TC (WMD = -1.58 mg/dl, 95% CI = -6.04, 2.88), and LDL-C levels (WMD = 1.85 mg/dl, 95% CI = 0.77, 2.92). Overall, HDL-C (WMD = -2.97 mg/dl; 95% CI = -6.43, 0.48 mg/dl) and VLDL-C (WMD = -1.41 mg/dl; 95% CI = -2.73, -0.10 mg/dl) significantly decreased after Ramadan fasting. A significant increase in LDL-C levels was observed in athletic subjects (WMD = 2.97 mg/dl; 95% CI = 0.80, 5.13) and apparently healthy subjects (WMD = 1.81 mg/dl; 95% CI = 0.55, 3.07). Change in TG levels was associated with age (β = -0.94, P = 0.043), its baseline values (β = -0.44, P = 0.001), and weight change during the fasting period (β = -0.57, P = 0.032). CONCLUSION Ramadan fasting may be accompanied by a moderate improvement of lipid and lipoprotein parameters, especially HDL-C levels; fasting appears to be more beneficial for men and athletic subjects.
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8.
Risk of diabetic ketoacidosis during Ramadan fasting: A critical reappraisal.
Beshyah, SA, Chowdhury, TA, Ghouri, N, Lakhdar, AA
Diabetes research and clinical practice. 2019;:290-298
Abstract
OBJECTIVES To evaluate the validity of the perceived increased risk and the actual occurrence of DKA observed during fasting in Ramadan. METHODS This is a non-systematic narrative review of the literature on the occurrence of DKA during Ramadan. Online databases (PubMed, Google Scholar, Cochrane Database, Medline OVID and CINAHL EBSCO) were searched. Three research questions are addressed 1. What is the basis of the expert opinion on the risk for DKA? 2. What is the likelihood that DKA is precipitated by Ramadan fast? and 3. What is the frequency of observed DKA during Ramadan? RESULTS The expert opinion suggesting a risk of DKA during Ramadan fasting was proposed with no evidence in the early writing on Ramadan fasting and has been reiterated and propagated since then. However, from first principles, DKA is not readily precipitated by the usual stress-free metabolic environment induced by Ramadan fasting with the exception of cases involved in the usual risk factors for metabolic decompensation. Furthermore, recent studies could not document any increase in observed DKA during Ramadan fasting in retrospective, prospective and database studies. CONCLUSIONS The current state of knowledge and evidence suggests the risk of DKA is not increased during Ramadan fasting.
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9.
C-R Relationship between Fasting Plasma Glucose and Unfavorable Outcomes in Patients of Ischemic Stroke withoutDiabetes.
Xing, L, Liu, S, Tian, Y, Yan, H, Jing, L, Chen, K, Yan, F, Li, Y, Lv, J, Sun, Y
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2019;(5):1400-1408
Abstract
BACKGROUND Limited data are available on the impact of fasting plasma glucose (FPG) on outcomes in nondiabetic acute ischemic stroke patients. METHODS The prospective, multi-center, and observational study was performed at 8 hospitals in the Liaoning Province between 2015-2016, sought to elucidate the relationship between FPG and the 6-month functional outcomes in nondiabetic acute ischemic stroke patients. The primary effect measure was the adjusted odds ratio for a shift in the direction of unfavorable outcome on the modified Rankin Scale (mRS) score at 6 months, estimated with an ordinal logistic regression, and adjusted for common prognostic factors. Finally, we employed a restricted cubic spline function of linear model to characterize concentration-response (C-R) relationships between FPG and outcomes. RESULTS A total of 1260 consecutive patients were enrolled, 48.9% of patients had FPG levels >6.1mmol/L. A total of 282 (22.4%) patients achieved an unfavorable neurologic outcome. Patients achieving an unfavorable neurologic outcome had significantly higher levels of FPG than those achieving a favorable neurologic outcome (6.47mmol/L versus 7.02 mmol/L). FPG was significantly related to an unfavorable neurologic outcome in nondiabetic acute ischemic stroke patients. The C-R curve showed a nonlinear relation between FPG and 6-month mRS with the nadir at 5.9mmol/L. Moreover, the likelihood of unfavorable outcome increased by 8.5% for each 1mmol/L increase in FPG. CONCLUSIONS Early identification and prompt hyperglycemia management should be considered to improve the functional outcomes during the early poststroke stage.
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10.
The influence of fasting and energy restricting diets on IGF-1 levels in humans: A systematic review and meta-analysis.
Rahmani, J, Kord Varkaneh, H, Clark, C, Zand, H, Bawadi, H, Ryan, PM, Fatahi, S, Zhang, Y
Ageing research reviews. 2019;:100910
Abstract
BACKGROUND Fasting and energy restricting diets have a potential means of delaying or preventing the onset of a range of age-related metabolic and neoplastic diseases. Consistently at the centre of this effect appears to be a significant reduction in circulating IGF-1 levels. The aim of the current systematic review and meta-analysis was to determine the influence of fasting and energy restriction on IGF-1 levels in human subjects. METHODS A comprehensive systematic search was conducted from onset of the database to February 2019 in Embase, MEDLINE/PubMed, and SCOPUS to identify randomized clinical trials that investigating the impact of fasting or energy restriction circulating IGF-1 levels. Effect size was reported as weighted mean difference (WMD) and 95% confidence intervals (CI) using a random-effects models. Subgroup analysis was performed to identify the probable source of heterogeneity among trials. RESULTS Total pooling of fasting and energy restriction randomised controlled trials in WMD analysis revealed no significant effect on circulating IGF-1 levels (WMD: -16.41 ng/ml, 95% CI: -35.88, 3.07). Sub grouped analysis fasting regimens appeared to substantially reduce IGF-1 (WMD: -28.87 ng/ml, 95% CI: -43.69, -14.05, I2 = 00%), energy restricting regimens failed to do the same (WMD: -10.98 ng/ml, 95% CI: -33.08, 11.11, I2 = 90%). Within this final subgrouping, it was observed that only energy restriction regimens of 50% or greater of normal daily energy intake were capable of significantly reducing IGF-1 levels (WMD: -36.57 ng/ml, 95% CI: -59.19, -13.95, I2 = 00%). Finally, a meta regression were noted in which the percentage restriction of daily energy intake inversely correlated with plasma IGF-1 levels (p = 0.04). CONCLUSION This study uncovered that fasting significantly reduced levels of IGF-1, while energy restriction diets were successful only when intake was reduced by 50% or more.