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Association of High Intakes of Vitamins B6 and B12 From Food and Supplements With Risk of Hip Fracture Among Postmenopausal Women in the Nurses' Health Study.
Meyer, HE, Willett, WC, Fung, TT, Holvik, K, Feskanich, D
JAMA network open. 2019;(5):e193591
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Abstract
IMPORTANCE Vitamin supplementation far exceeding recommended doses is popular in segments of the population. However, adverse effects can occur. In a previous secondary analysis of combined data from 2 double-blind randomized clinical trials (RCTs), an unexpected increased risk of hip fracture was found among those treated with high doses of vitamin B6 in combination with vitamin B12. OBJECTIVES To study if high intakes of vitamins B6 and B12 from food and supplements were associated with a risk of hip fracture in the Nurses' Health Study and to investigate whether combined high intakes of both vitamins conferred a particularly increased fracture risk. DESIGN, SETTING, AND PARTICIPANTS In this prospective cohort study, 75 864 postmenopausal women in the United States were followed up from June 1984 through May 2014. The dates of analysis were July 2016 to June 2018. Information on hip fracture and a wide range of potential confounders was collected at baseline and with biennial follow-up questionnaires. Extensive dietary information was collected approximately every 4 years with a semiquantitative food frequency questionnaire. Relative risks (RRs) were calculated by Cox proportional hazards regression, with cumulative average intakes of vitamins B6 and B12 as main exposures, adjusting for potential confounders. MAIN OUTCOME AND MEASURE Hip fracture. RESULTS During follow-up, 2304 of 75 864 women had a hip fracture. Among the women with hip fractures, the median (range) age at hip fracture was 75.8 (46.7-93.0) years and the mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 24.3 (4.6). Median (interquartile range) cumulative average intakes of total vitamins B6 and B12 were 3.6 (4.8) mg/d and 12.1 (11.7) μg/d, respectively. Both vitamin B6 (RR, 1.29; 95% CI, 1.04-1.59 for an intake of ≥35 vs <2 mg/d; P = .06 for linear trend) and vitamin B12 (RR, 1.25; 95% CI, 0.98-1.58 for an intake of ≥30 vs <5 μg/d; P = .02 for linear trend) were associated with increased fracture risk. Risk was highest in women with a combined high intake of both vitamins (B6 ≥35 mg/d and B12 ≥20 μg/d), exhibiting an almost 50% increased risk of hip fracture (RR, 1.47; 95% CI, 1.15-1.89) compared with women with a low intake of both vitamins (B6 <2 mg/d and B12 <10 μg/d). CONCLUSIONS AND RELEVANCE In this cohort study, a combined high intake of vitamins B6 and B12 was associated with an increased risk of hip fracture. The intakes were far higher than the recommended dietary allowances. These findings add to previous studies suggesting that vitamin supplements should be used cautiously because adverse effects can occur.
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Effects of ginseng supplementation on selected markers of inflammation: A systematic review and meta-analysis.
Mohammadi, H, Hadi, A, Kord-Varkaneh, H, Arab, A, Afshari, M, Ferguson, AJR, Ghaedi, E
Phytotherapy research : PTR. 2019;(8):1991-2001
Abstract
The present meta-analysis was performed to evaluate the efficacy of ginseng administration on serum level of inflammatory biomarkers. We performed a systematic search of all available randomized controlled trials (RCTs) conducted up to June 2018 in the following electronic databases: PubMed, Scopus, Cochrane, and Google Scholar. RCTs that investigated the effect ginseng supplementation on high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were included for final analysis. A total of seven RCTs were included in the meta-analysis. Results indicated significant reduction in IL-6 (mean difference [MD]: -0.265 pg/ml, 95% CI [-0.396, -0.135], p < .001) and TNF-α (MD: -2.471 pg/ml, 95% CI [-2.904, -2.039], p < .001) and no significant change in hs-CRP (MD: -0.125 mg/L, 95% CI [-0.597, 0.347], p = .604). Although there was publication bias across studies, trim and fill analysis showed that results from unpublished studies could not change the results for CRP. However, removing one study in sensitivity analysis did reveal a significant reduction in CRP. We conclude that ginseng supplementation significantly lowered IL-6 and TNF-α but did not significantly lower CRP. However, these findings were not robust, because they showed sensitivity for CRP and IL-6, and future long-term well-designed dose-escalating trials are required.
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Effects of grape products on blood lipids: a systematic review and dose-response meta-analysis of randomized controlled trials.
Ghaedi, E, Moradi, S, Aslani, Z, Kord-Varkaneh, H, Miraghajani, M, Mohammadi, H
Food & function. 2019;(10):6399-6416
Abstract
The purpose of the present study was to critically assess the effects of grape product supplementation on lipid profiles in adults. A comprehensive electronic search was performed with no limitation in time and language. All randomized controlled trials (RCT) that reported the effects of grape products in any form on lipid profiles were included. Moreover, fifty-nine arms from forty-eight RCTs were included in the present study. Meta-analysis indicated that the consumption of grape products reduced the concentration of total cholesterol (MD: -6.196 mg dl-1, 95% CI: -9.203, -3.189), low-density lipoprotein (MD: -4.964 mg dl-1, 95% CI: -7.594, -2.334) and triglyceride (MD: -7.641 mg dl-1, 95% CI: -12.120, -3.162). However, grape products did not have significant effects on the concentration of high-density lipoprotein (MD: 0.385 mg dl-1, 95% CI: -0.364, 1.133). Grape product supplementation changed the HDL and LDL in a non-linear fashion based on the dose of polyphenols. The present study revealed that grape products might have a favorable role in the achievement of a lipid profile target.
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Influence of curcumin supplementation on metabolic and lipid parameters of people living with HIV/AIDS: a randomized controlled trial.
Silva, TAL, Medeiros, DC, Medeiros, GCBS, Medeiros, RCSC, de Souza Araújo, J, Medeiros, JA, Ururahy, MAG, Santos, RVT, Medeiros, RMV, Leite-Lais, L, et al
BMC complementary and alternative medicine. 2019;(1):202
Abstract
BACKGROUND Scientific studies have shown that the potential therapeutic efficacy of curcumin in several diseases is due to its potent antioxidant and anti-inflammatory properties. Consequently, curcumin supplementation seems to be a valuable alternative for HIV-infected individuals. The aim of this study is to evaluate the influence of curcumin supplementation on substrate oxidation at rest, body composition, and the lipid profile of physically active people living with HIV/AIDS under antiretroviral therapy. METHODS This double-blind, crossover, randomized clinical trial was comprised of 20 subjects divided into experimental (EG) and control (CG) groups, receiving 1000 mg curcumin/day and placebo, respectively, during a 30-day period. Substrate oxidation at rest was assessed by indirect calorimetry, body composition was measured by dual-energy x-ray absorptiometry, and the lipid profile was evaluated by blood tests. Data analysis was performed by independent samples and paired t-tests to compare the differences between groups and times. A p-value < 0.05 was accepted as significant. RESULTS There were no differences between groups regarding substrate oxidation at rest or body composition. However, serum triglyceride levels were increased after curcumin supplementation (182 vs. 219 mg/dL; p = 0.004). CONCLUSION Curcumin supplementation promoted the elevation of serum triglyceride levels in HIV-infected subjects. Further studies with a larger sample cohort, different curcumin doses, and longer intervention times are needed to validate current observations. In addition, the influence of physical activity, dietary intake, and genetic polymorphisms must be considered in future studies to better understand the impact of curcumin supplementation on the lipid profile of people living with HIV/AIDS under antiretroviral therapy.
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Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso.
Brabin, B, Gies, S, Roberts, SA, Diallo, S, Lompo, OM, Kazienga, A, Brabin, L, Ouedraogo, S, Tinto, H
Malaria journal. 2019;(1):161
Abstract
BACKGROUND Iron supplementation before a first pregnancy may improve the future health of mother and baby by reducing maternal anaemia. Iron supplementation could, however, increase malaria infections, notably in primigravidae who are most susceptible. The pathogenicity of other iron-utilizing pathogens could also increase, causing inflammation leading to increased risk of adverse birth outcomes. This paper reports pre-specified secondary birth outcomes from a safety trial in Burkina Faso in an area of high malaria endemicity. Primary outcomes from that trial had investigated effects of long-term weekly iron supplementation on malaria and genital tract infections in non-pregnant and pregnant women. METHODS A double-blind, randomized controlled trial. Nulliparous, mainly adolescent women, were individually randomized periconceptionally to receive weekly either 60 mg elemental iron and 2.8 mg folic acid, or 2.8 mg folic acid alone, continuing up to the first antenatal visit for those becoming pregnant. Secondary outcomes were ultrasound-dated gestational age, fetal growth, placental malaria, chorioamnionitis and iron biomarkers. Seasonal effects were assessed. Analysis was by intention to treat. RESULTS 478 pregnancies occurred to 1959 women: 258/980 women assigned iron and folic acid and 220/979 women assigned folic acid alone. Malaria prevalence at the first antenatal visit was 53% (iron) and 55% (controls). Mean birthweight was 111 g lower in the iron group (95% CI 9:213 g, P = 0.033). Mean gestational ages were 264 days (iron) and 269 days (controls) (P = 0.012), with 27.5% under 37 weeks compared to 13.9% in controls (adjRR = 2.22; 95% CI 1.39-3.61) P < 0.001). One-third of babies were growth restricted, but incidence did not differ by trial arm. Half of placentae had evidence of past malaria infection. C-reactive protein > 5 mg/l was more common prior to births < 37 weeks (adjRR = 2.06, 95% CI 1.04-4.10, P = 0.034). Preterm birth incidence during the rainy season was ~ 50% in the iron arm and < 20% in controls (P = 0.001). Chorioamnionitis prevalence peaked in the dry season (P = 0.046), with no difference by trial arm (P = 0.14). CONCLUSION Long-term weekly iron supplementation given to nulliparous women in a malaria endemic area was associated with higher risk of preterm birth in their first pregnancy. Trial Registration NCT01210040. Registered with Clinicaltrials.gov on 27th September 2010.
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United States Pharmacopeia Safety Review of Willow Bark.
Oketch-Rabah, HA, Marles, RJ, Jordan, SA, Low Dog, T
Planta medica. 2019;(16):1192-1202
Abstract
Willow bark (Salix spp.) is an ingredient in some dietary supplements. No serious adverse effects were reported from trials of willow bark extracts delivering 120 - 240 mg salicin (the purported active constituent) daily for up to 8 weeks. All studies involved adults only; none involved special subpopulations such as pregnant or breastfeeding women, or children. The most common adverse effects associated with willow bark are gastrointestinal; a few allergic reactions were also reported. Some publications advise caution when taking willow bark. There is a risk of increased bleeding in vulnerable individuals, salicylates cross the placenta and are eliminated slowly in newborns, some persons are sensitive or allergic to aspirin, and children are at risk of Reye syndrome. Concurrent use with other salicylate-containing medicines increases these risks. Metabolism of 240 mg salicin from willow bark could yield 113 mg of salicylic acid, yet dietary supplement products are not required to be labeled with warnings. In contrast, over-the-counter low-dose aspirin (81 mg strength), which delivers 62 mg salicylic acid, is required by law to include cautions, warnings, and contraindications related to its use in pregnant and nursing women, children, and other vulnerable subpopulations, e.g., those using anticoagulants. In the interest of protecting public health, the United States Pharmacopeia has included a cautionary labeling statement in the United States Pharmacopeia Salix Species monograph as follows: "Dosage forms prepared with this article should bear the following statement: 'Not for use in children, women who are pregnant or nursing, or by persons with known sensitivity to aspirin.'".
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Germination in Optimal Conditions as Effective Strategy to Improve Nutritional and Nutraceutical Value of Underutilized Mexican Blue Maize Seeds.
Chavarín-Martínez, CD, Gutiérrez-Dorado, R, Perales-Sánchez, JXK, Cuevas-Rodríguez, EO, Milán-Carrillo, J, Reyes-Moreno, C
Plant foods for human nutrition (Dordrecht, Netherlands). 2019;(2):192-199
Abstract
Germination of grains is a bioprocess of emerging interest to improve nutritional and nutraceutical profile of cereals in a natural way. The aim of this work was to identify optimal germination conditions (temperature/duration) for producing a functional blue maize flour with maximum values of protein content (PC), antioxidant activity (AoxA), and total phenolic and anthocyanin contents (TPC, TAC). A central composite rotatable experimental design (response surface methodology) with two factors [Germination temperature (Gtemp, 20-40 °C) / Germination duration (Gdur, 12-220 h)] in five levels was used (13 treatments). Blue maize seeds were soaked in distilled water (25 °C / 12 h) before germination. The sprouts were dried, tempered (25 °C), and ground to obtain germinated blue maize flours (GBMF). The prediction models developed for each response variable showed high coefficients of determination, demonstrating their adequacy to explain the variations in experimental data. Maximum values of PC, AoxA, TPC, and TAC were attained at Gtemp = 26.9 °C / Gdur = 207.7 h. Optimized germinated blue maize flour (OGBMF) presented higher PC (+38.48%), AoxA (ABTS: +192%, ORAC +160%, DPPH +148%), TPC (+79%), and TAC (+9.9%) than unprocessed blue maize flour (UBMF). Germination at optimal conditions is an effective strategy to increase the nutritional/nutraceutical quality of blue maize seeds, thus the flour of these germinated seeds could be used for the development of functional foods.
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New Trends in Antioxidant Compounds: A Precise Nutraceutical in Cardiometabolic Disorders.
Caliceti, C, Urao, N, Rizzo, P, Giuliano, M
Oxidative medicine and cellular longevity. 2019;:4794563
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The Unregulated Probiotic Market.
de Simone, C
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2019;(5):809-817
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Abstract
BACKGROUND & AIMS This narrative review provides an overview of the current regulation of probiotics, with a focus on those used for the dietary management of medical conditions (Medical Foods). FINDINGS The probiotic market has grown rapidly, both for foods and supplements intended to enhance wellness in healthy individuals, and for preparations for the dietary management of disease. Regulation of probiotics varies between regions. Unless they make specific disease-related health claims, probiotics are regulated as food supplements and regulation is focused on the legitimacy of any claims, rather than efficacy, safety and quality. Many properties of probiotics are strain-specific, and safety and efficacy findings associated to specific formulations should not be generalized to other probiotic products. Manufacturing processes, conditions and ingredients are important determinants of product characteristics and changes to manufacturing are likely to give rise to a product not identical to the "original" in efficacy and safety if proper measures and controls are not taken. Current trademark law and the lack of stringent regulation of probiotic manufacturing mean that the trademark owner can commercialize any formulation under the same brand, even if significantly different from the original. These regulatory deficits may have serious consequences for patients where probiotics are used as part of clinical guideline-recommended management of serious conditions such as inflammatory bowel diseases, and may make doctors liable for prescribing a formulation not previously tested for safety and efficacy. CONCLUSIONS Current regulation of probiotics is inadequate to protect consumers and doctors, especially when probiotics are aimed at the dietary management of serious conditions.
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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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Abstract
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.