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Assessment of adverse reactions to α-lipoic acid containing dietary supplements through spontaneous reporting systems.
Gatti, M, Ippoliti, I, Poluzzi, E, Antonazzo, IC, Moro, PA, Moretti, U, Menniti-Ippolito, F, Mazzanti, G, De Ponti, F, Raschi, E
Clinical nutrition (Edinburgh, Scotland). 2021;(3):1176-1185
Abstract
BACKGROUND & AIMS Alpha-lipoic acid (ALA)-containing dietary supplements are widely used in clinical practice, although their safety assessment is under-investigated. We characterize the safety profile of ALA-containing products by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS Suspected ARs to ALA-containing products were extracted from the Italian Phytovigilance System (IPS), and scrutinized in terms of seriousness and causality (through WHO UMC system), with a specific focus on important (IMEs) and designated medical events (DMEs). To characterize the reporting profile from an international perspective, the WHO-VigiBase was also queried. RESULTS From March 2002 to February 2020, out of 2147 total reports, 116 reports concerning 212 ARs to ALA-containing products were collected. Women were involved in 68.1% of cases. Skin (44.9%) and gastrointestinal disorders (10.8%) were the most frequently represented ARs. Causality assessment resulted as definite (15), probable (35), possible (24), unlikely (5), and unclassifiable (37). In 70% of cases, events occurred within 30 days of ALA use. Forty-five reports were serious (38.8%), being insulin autoimmune syndrome the most frequently reported (N = 10). IMEs were recorded in 20 cases, including four DMEs (3 angioedema and one anaphylactic shock). Similar distribution emerged from the 5641 reports in the WHO-VigiBase. CONCLUSIONS The remarkable reporting of unpredictable skin, immune and hepatic ARs, coupled with seriousness, strong causality and early onset, calls for a) careful risk-benefit assessment of ALA-containing products by regulators; b) awareness and monitoring by clinicians and c) continuous vigilance of their safety profile through valuable spontaneous reporting systems such as IPS.
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Profiles for identifying problematic dietary habits in a sample of recreational Spanish cyclists and triathletes.
Muros, JJ, Knox, E, Hinojosa-Nogueira, D, Rufián-Henares, JÁ, Zabala, M
Scientific reports. 2021;(1):15193
Abstract
There is a lack of sufficient information on the dietary intake and nutritional supplementation of recreational endurance athletes throughout the year. The present observational study sought to assess the dietary intake and nutritional supplementation habits of recreational cyclists and triathletes from Spain. 4,037 cyclists and triathletes completed self-report measures. Nutritional profiles were developed and differences were examined according to sporting discipline and gender. Differences between groups were compared using the Mann-Whitney U or chi-squared test. Next, micro- and macro-nutrients were grouped according to whether or not guideline intake amounts were met. The clustering of dietary habits was then examined via K-means cluster analysis. Triathletes took more supplements than cyclists (X2 = 36.489; p value = .000) and females took more supplements than males (X2 = 5.920; p value = .017). Females and triathletes reported greater protein and CHO consumption than males and cyclists, respectively. Triathletes also reported a higher consumption of total fat, MUFA, PUFA, EPA, DHA and fibre. Females and triathletes tended to consume more vitamins and minerals than males and cyclists, respectively. Two main dietary habit clusters emerged which may be used to inform nutritional interventions targeting recreational athletes not meeting nutritional requirements. There is an imbalance in the main nutrients making up the diet of recreational Spanish athletes, characterised by insufficient CHO and excessive protein.
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Association between potassium supplementation and the occurrence of acute kidney injury in patients with hypokalemia administered liposomal amphotericin B: a nationwide observational study.
Ota, Y, Obata, Y, Takazono, T, Tashiro, M, Wakamura, T, Takahashi, A, Shiozawa, Y, Miyazaki, T, Nishino, T, Izumikawa, K
BMC nephrology. 2021;(1):240
Abstract
BACKGROUND Hypokalemia and acute kidney injury (AKI) occur in patients administered liposomal amphotericin B (L-AMB), a wide-spectrum anti-fungicidal drug. However, the association between potassium supplementation and the occurrence of AKI in patients with hypokalemia who were administered L-AMB is not well understood. METHODS Using nationwide claims data and laboratory data, the occurrence of AKI during L-AMB treatment was retrospectively compared between patients with hypokalemia who were or were not supplemented with potassium and between those adequately or inadequately supplemented with potassium (serum potassium levels corrected to ≥3.5 mEq/L or remained < 3.5 mEq/L, respectively) before or after L-AMB treatment initiation. RESULTS We identified 118 patients who developed hypokalemia before L-AMB treatment initiation (43 received potassium supplementation [25 adequate and 18 inadequate supplementation] and 75 did not receive potassium supplementation), and 117 patients who developed hypokalemia after L-AMB initiation (79 received potassium supplementation [including 23 adequate and 15 inadequate supplementation] and 38 did not receive potassium supplementation). The occurrence of any stage of AKI was similar between patients with hypokalemia, regardless of potassium supplementation (i.e., before L-AMB treatment initiation [supplementation, 51%; non-supplementation, 45%; P = 0.570] or after L-AMB initiation [supplementation, 28%; non-supplementation, 32%; P = 0.671]). After adjusting for confounding factors, we found that the occurrence of any stage of AKI was not associated with potassium supplementation before L-AMB initiation (odds ratio [OR]: 1.291, 95% confidence interval [CI]: 0.584-2.852, P = 0.528) or after L-AMB initiation (OR: 0.954, 95% CI: 0.400-2.275, P = 0.915). The occurrence of any stage of AKI tended to decline in patients with hypokalemia who were adequately supplemented with potassium (44%) before, but not after, L-AMB initiation relative to that in patients inadequately supplemented with potassium (61%), however this result was not significant (P = 0.358). CONCLUSION Potassium supplementation was not associated with any stage of AKI in patients with hypokalemia who were administered L-AMB.
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Health Behaviors and Psychosocial Attributes of US Soldiers.
Kegel, JL, Kazman, JB, Scott, JM, Deuster, PA
Journal of the Academy of Nutrition and Dietetics. 2020;(9):1469-1483
Abstract
BACKGROUND Health trends, which promote performance enhancement and maintaining or increasing muscle strength, may appeal to soldiers looking to maintain health standards set by the US Army, but often these trends require further investigation to assess safety and efficacy. High-intensity interval training (HIIT) and use of weight loss and/or performance-enhancing/body-building dietary supplements (WL/PES DS) are two such trends that, if implemented inappropriately, can negatively impact soldier health and readiness. OBJECTIVE Our aim was to establish health/psychosocial profiles of US Army soldiers who participate in HIIT and/or use WL/PES DS. DESIGN This cross-sectional observational study used data from the 2016 US Army Global Assessment Tool. PARTICIPANTS Data were analyzed from respondents to the 2016 US Army Global Assessment Tool (n=299,996) who consented to have their data used for research purposes. RESULTS Soldiers were classified into four groups based on HIIT and/or WL/PES DS use. Thirty-five percent of soldiers participated in HIIT and 10% took WL/PES DS at least once per month in the last year. HIIT participation was associated with higher reported odds of healthy behaviors and higher emotional and social fitness. In contrast to HIIT, WL/PES DS use was associated with higher reported odds of risky behaviors (hazardous drinking and tobacco use) and lower psychosocial fitness. The group participating in HIIT but not using WL/PES DS reported fewer unhealthy behaviors compared to the HIIT+WL/PES DS and WL/PES DS-only groups. CONCLUSIONS Engaging in HIIT is associated with higher reported odds of healthy behaviors and increased psychosocial fitness. However, soldiers who engaged in HIIT also have increased odds of WL/PES DS use, which is associated with greater reported risky behaviors and reduced fitness. Although HIIT and WL/PES DS use are related, they are associated with different reported health/risky behaviors and different psychosocial attributes.
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During Hospitalization, Older Patients at Risk for Malnutrition Consume <0.65 Grams of Protein per Kilogram Body Weight per Day.
Weijzen, MEG, Kouw, IWK, Geerlings, P, Verdijk, LB, van Loon, LJC
Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition. 2020;(4):655-663
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Abstract
BACKGROUND Malnutrition is prevalent in hospitalized patients. To support muscle maintenance in older and chronically ill patients, a protein intake of 1.2-1.5 g/kg/d has been recommended during hospitalization. We assessed daily protein intake levels and distribution in older patients at risk for malnutrition during hospitalization. METHODS In this prospective, observational study, we measured actual food and food supplement consumption in patients (n = 102; age, 68 ± 14 years; hospital stay, 14 [8-28] days) at risk of malnutrition during hospitalization. Food provided by hospital meals, ONS, and snacks and the actual amount of food (not) consumed were weighed and recorded for all patients. RESULTS Hospital meals provided 1.03 [0.77-1.26] protein, whereas actual protein consumption was only 0.65 [0.37-0.93] g/kg/d. Protein intake at breakfast, lunch, and dinner was 10 [6-15], 9 [5-14], and 13 [9-18] g, respectively. The use of ONS (n = 62) resulted in greater energy (1.26 [0.40-1.79] MJ/d, 300 [100-430] kcal/d) and protein intake levels (11 [4-16] g/d), without changing the macronutrient composition of the diet. CONCLUSION Despite protein provision of ∼1.0 g/kg/d, protein intake remains well below these values (∼0.65 g/kg/d), as 30%-40% of the provided food and supplements is not consumed. Provision of ONS may increase energy and protein intake but does not change the macronutrient composition of the diet. Current nutrition strategies to achieve the recommended daily protein intake in older patients during their hospitalization are not as effective as generally assumed.
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Use of dietary supplements containing soy isoflavones and breast cancer risk among women aged >50 y: a prospective study.
Touillaud, M, Gelot, A, Mesrine, S, Bennetau-Pelissero, C, Clavel-Chapelon, F, Arveux, P, Bonnet, F, Gunter, M, Boutron-Ruault, MC, Fournier, A
The American journal of clinical nutrition. 2019;(3):597-605
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BACKGROUND Soy-based dietary supplements have been promoted as natural alternatives to menopausal hormone therapy, but their potential effect on breast cancer development is controversial. OBJECTIVES We examined the relation between the consumption of soy supplements and the risk of breast cancer, overall and by tumor hormone receptor status, among women aged >50 y. METHODS In total, 76,442 women from the Etude Epidemiologique aupres de Femmes de la Mutuelle Generale de l'Education Nationale (E3N) cohort, born between 1925 and 1950, were followed from 2000 to 2011 (11.2 y on average, starting at a mean age of 59.5 y; 3608 incident breast cancers), with soy supplement use assessed every 2-3 y. HRs of breast cancer were estimated with the use of multivariable Cox models. RESULTS Compared with never using soy supplements, the HRs associated with current use of soy supplements were 0.92 (95% CI: 0.76, 1.11) for all, 0.78 (95% CI: 0.60, 0.99) for estrogen receptor (ER)-positive, and 2.01 (95% CI: 1.41, 2.86) for ER-negative breast cancers. There was no association between past use of soy supplements and breast cancer. HRs for current use were 1.36 (95% CI: 0.95, 1.93) and 0.82 (95% CI: 0.65, 1.02) among women with and without a family history of breast cancer, respectively (P-interaction = 0.03) and 1.06 (95% CI: 0.87, 1.30) ≥5 y after menopause compared with 0.50 (95% CI: 0.31, 0.81) in premenopause or ≤5 y postmenopause (P-interaction = 0.04). CONCLUSIONS In this cohort of women aged >50 y, we report opposing associations of soy supplements with ER-positive and ER-negative breast cancer risk. Our results also caution against the use of these supplements in women with a family history of breast cancer. Whether the risk profile of soy supplements could be more favorable among premenopausal or recently postmenopausal women deserves further investigation.
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Cytotoxic Lesions of the Corpus Callosum Caused by Thermogenic Dietary Supplements.
Galnares-Olalde, JA, Vázquez-Mézquita, AJ, Gómez-Garza, G, Reyes-Vázquez, D, Higuera-Ortiz, V, Alegría-Loyola, MA, Mendez-Dominguez, A
AJNR. American journal of neuroradiology. 2019;(8):1304-1308
Abstract
Consumption of over-the-counter dietary supplements to reduce body weight is common among the population. Thermogenics are herbal combinations that claim to produce a fat-burning process through an increase in the cellular metabolic rate and greater cellular energy consumption, having a high risk for patients developing toxic leukoencephalopathy. We present a series of 6 patients with acute neurologic symptoms and MR imaging showing restricted diffusion and decreased apparent diffusion coefficient values (mean value, 400 mm2/s × 10-6) in the entire corpus callosum compatible with a cytotoxic lesion of the corpus callosum. Although patients responded favorably to the product discontinuation with rapid recovery of neurologic symptoms, there was a more prolonged resolution on imaging alterations. Because of the widespread availability and unregulated nature of thermogenic dietary supplements, physicians must be aware of the clinical and radiologic characteristics of these potential complications of their use.
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Maternal dietary patterns, supplements intake and autism spectrum disorders: A preliminary case-control study.
Li, YM, Shen, YD, Li, YJ, Xun, GL, Liu, H, Wu, RR, Xia, K, Zhao, JP, Ou, JJ
Medicine. 2018;(52):e13902
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The aim of this study was first to investigate associations between maternal dietary patterns and autism spectrum disorders (ASDs) and second to investigate association between maternal supplement intake and ASD.We used a case-control study design to enroll typically developing (TD) children and children with ASD, and data were derived from the Autism Clinical and Environmental Database (ACED).Three seventy four children with AUTISM and 354 age matched TD children were included. The multivariate logistic regression model revealed that maternal unbalanced dietary patterns before conception had a significant increased risk of ASD in offspring (mostly meat: adjusted OR, 4.010 [95% CI, 1.080, 14.887]; mostly vegetable: adjusted OR, 2.234 [95% CI, 1.009, 4.946]); maternal supplementation of calcium during pregnancy preparation was associated with decreased ASD risk (adjusted OR, 0.480 [95% CI, 0.276, 0.836]).This study provided preliminary evidence that maternal unbalanced dietary patterns may be a risk factor for ASD and supplementation of calcium during pregnancy preparation may be inversely associated with ASD in offspring.
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Short Malnourished Children and Fat Accumulation With Food Supplementation.
Fabiansen, C, Phelan, KPQ, Cichon, B, Yaméogo, CW, Iuel-Brockdorff, AS, Kurpad, A, Wells, JC, Ritz, C, Filteau, S, Briend, A, et al
Pediatrics. 2018;(3)
Abstract
BACKGROUND In moderate acute malnutrition programs, it is common practice to not measure mid-upper arm circumference (MUAC) of children whose length is <67 cm. This is based on expert opinion that supplementation of shorter children with low MUAC and weight-for-height z score ≥-2 may increase risk of excessive fat accumulation. Our aim was to assess if shorter children gain more fat than taller children when treated for moderate acute malnutrition diagnosed by low MUAC alone. METHODS In this observational study, we included children aged 6 to 23 months with a MUAC between 115 and 125 mm and a weight-for-height z score ≥-2. On the basis of length at admission, children were categorized as short if <67 cm and long if ≥67 cm. Linear mixed-effects models were used to assess body composition on the basis of deuterium dilution and skinfold thickness. RESULTS After 12 weeks of supplementation, there was no difference in change in fat mass index (-0.038 kg/m2, 95% confidence interval [CI]: -0.257 to 0.181, P = .74) or fat-free mass index (0.061 kg/m2, 95% CI: -0.150 to 0.271, P = .57) in short versus long. In absolute terms, the short children gained both less fat-free mass (-230 g, 95% CI: -355 to -106, P < .001) and fat mass (-97 g, 95% CI: -205 to 10, P = .076). There was no difference in changes in absolute subscapular and triceps skinfold thickness and z scores (P > .5). CONCLUSIONS Short children with low MUAC do not gain excessive fat during supplementation. With these data, we support a recommendation for policy change to include all children ≥6 months with low MUAC in supplementary feeding programs, regardless of length. The use of length as a criterion for measuring MUAC to determine treatment eligibility should be discontinued in policy and practice.
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Etiologic risk factors and vitamin D receptor gene polymorphisms in under one-year-old infants with urolithiasis.
Ergon, EY, Akil, İO, Taneli, F, Oran, A, Ozyurt, BC
Urolithiasis. 2018;(4):349-356
Abstract
The incidence of urinary tract stones in infancy has been increasing in Turkey. Risk factors and vitamin D receptor (VDR) gene polymorphisms were investigated in infants aged < 1 year who had stones. Forty infants with urinary tract stones and 80 infants without stones, aged < 1 year were enrolled in this study. Detailed surveys were taken of all infants, metabolic parameters and ApaI and FokI VDR gene polymorphisms were investigated. Infants with stones tended to be more commonly fed formula and multivitamins (vitamins A, C, D) (p < 0.05). Positive family history came into prominence in the stony group (p < 0.05). There were no significant differences in ApaI and FokI VDR gene polymorphisms between the groups with stones and the control groups. However, CA genotype of ApaI polymorphism was associated with family history and C allele of ApaI was related with family history and hypercalciuria (p < 0.05). Hypercalciuria emerged as an underlying metabolic abnormality in the etiology of stones, and was observed at a rate of 38%. Infants who are given formula and multivitamins for vitamin D supplementation are at increased risk for the formation of urinary tract stones. VDR gene polymorphisms cause the formation of urinary tract stones and affect calcium (Ca) metabolism.