-
1.
Effect of high dose folic acid supplementation in pregnancy on pre-eclampsia (FACT): double blind, phase III, randomised controlled, international, multicentre trial.
Wen, SW, White, RR, Rybak, N, Gaudet, LM, Robson, S, Hague, W, Simms-Stewart, D, Carroli, G, Smith, G, Fraser, WD, et al
BMJ (Clinical research ed.). 2018;:k3478
-
-
Free full text
-
Abstract
OBJECTIVE To determine the efficacy of high dose folic acid supplementation for prevention of pre-eclampsia in women with at least one risk factor: pre-existing hypertension, prepregnancy diabetes (type 1 or 2), twin pregnancy, pre-eclampsia in a previous pregnancy, or body mass index ≥35. DESIGN Randomised, phase III, double blinded international, multicentre clinical trial. SETTING 70 obstetrical centres in five countries (Argentina, Australia, Canada, Jamaica, and UK). PARTICIPANTS 2464 pregnant women with at least one high risk factor for pre-eclampsia were randomised between 2011 and 2015 (1144 to the folic acid group and 1157 to the placebo group); 2301 were included in the intention to treat analyses. INTERVENTION Eligible women were randomised to receive either daily high dose folic acid (four 1.0 mg oral tablets) or placebo from eight weeks of gestation to the end of week 16 of gestation until delivery. Clinicians, participants, adjudicators, and study staff were masked to study treatment allocation. MAIN OUTCOME MEASURE The primary outcome was pre-eclampsia, defined as hypertension presenting after 20 weeks' gestation with major proteinuria or HELLP syndrome (haemolysis, elevated liver enzymes, low platelets). RESULTS Pre-eclampsia occurred in 169/1144 (14.8%) women in the folic acid group and 156/1157 (13.5%) in the placebo group (relative risk 1.10, 95% confidence interval 0.90 to 1.34; P=0.37). There was no evidence of differences between the groups for any other adverse maternal or neonatal outcomes. CONCLUSION Supplementation with 4.0 mg/day folic acid beyond the first trimester does not prevent pre-eclampsia in women at high risk for this condition. TRIAL REGISTRATION Current Controlled Trials ISRCTN23781770 and ClinicalTrials.gov NCT01355159.
-
2.
Prohibited Contaminants in Dietary Supplements.
Mathews, NM
Sports health. 2018;(1):19-30
-
-
Free full text
-
Abstract
CONTEXT With the increasing use of unregulated dietary supplements, athletes are at continued risk from adverse medical events and inadvertent doping. EVIDENCE ACQUISITION A review of Clinical Key, MEDLINE, and PubMed databases from 2012 to 2017 was performed using search terms, including dietary supplement, contamination, doping in athletes, inadvertent doping, and prohibited substances. The references of pertinent articles were reviewed for other relevant sources. STUDY DESIGN Clinical review. LEVEL OF EVIDENCE Level 3. RESULTS Poor manufacturing processes and intentional contamination with many banned substances continue to occur in dietary supplements sold in the United States. Certain sectors, such as weight loss and muscle-building supplements, pose a greater threat because they are more likely to be contaminated. CONCLUSION Athletes will continue to be at risk for adverse events and failed doping tests due to contaminated dietary supplements until legislation changes how they are regulated. In the interim, there are several steps that can be taken to mitigate this risk, including improved education of medical staff and athletes and use of third party-certified products.
-
3.
Effects of EPA and lipoic acid supplementation on circulating FGF21 and the fatty acid profile in overweight/obese women following a hypocaloric diet.
Escoté, X, Félix-Soriano, E, Gayoso, L, Huerta, AE, Alvarado, MA, Ansorena, D, Astiasarán, I, Martínez, JA, Moreno-Aliaga, MJ
Food & function. 2018;(5):3028-3036
Abstract
FGF21 has emerged as a key metabolism and energy homeostasis regulator. Dietary supplementation with eicosapentaenoic acid (EPA) and/or α-lipoic acid (LIP) has shown beneficial effects on obesity. In this study, we evaluated EPA and/or LIP effects on plasma FGF21 and the fatty acid (FA) profile in overweight/obese women following hypocaloric diets. At the baseline, FGF21 levels were negatively related to the AST/ALT ratio and HMW adiponectin. The weight loss did not cause any significant changes in FGF21 levels, but after the intervention FGF21 increased in EPA-supplemented groups compared to non-EPA-supplemented groups. EPA supplementation decreased the plasma n-6-PUFA content and increased n-3-PUFAs, mainly EPA and DPA, but not DHA. In the LIP-alone supplemented group a decrease in the total SFA and n-6-PUFA content was observed after the supplementation. Furthermore, EPA affected the desaturase activity, lowering Δ4D and raising Δ5/6D. These effects were not observed in the LIP-supplemented groups. Besides, the changes in FGF21 levels were associated with the changes in EPA, n-3-PUFAs, Δ5/6D, and n-6/n-3 PUFA ratio. Altogether, our study suggests that n-3-PUFAs influence FGF21 levels in obesity, although the specific mechanisms implicated remain to be elucidated.
-
4.
Effect of Protein Supplementation During Diet-Induced Weight Loss on Muscle Mass and Strength: A Randomized Controlled Study.
Smith, GI, Commean, PK, Reeds, DN, Klein, S, Mittendorfer, B
Obesity (Silver Spring, Md.). 2018;(5):854-861
-
-
Free full text
-
Abstract
OBJECTIVE High protein (particularly leucine-rich whey protein) intake is recommended to mitigate the adverse effect of weight loss on muscle mass. The effectiveness of this approach is unknown. METHODS Seventy middle-aged (50-65 years old) postmenopausal women with obesity were randomized to (1) weight maintenance (WM), (2) weight loss and the recommended daily allowance for protein (0.8 g/kg/d) (WL group), or (3) weight loss plus whey protein supplementation (total protein: 1.2 g/kg/d) (WL-PS group). Thigh muscle volume and strength were assessed at baseline and after 5% and 10% weight loss in the weight-loss groups and after matched time periods (∼3 and 6 months, respectively) in the WM group. RESULTS A 5% weight loss caused a greater decrease in thigh muscle volume in the WL group than the WL-PS group (4.7% ± 0.7% vs. 2.8% ± 0.8%, respectively; P < 0.05). After 10% weight loss, there was no statistically significant difference in muscle mass loss in the two groups, and the total loss was small in both groups (5.5% ± 0.8% and 4.5% ± 0.7%, respectively). The dietary interventions did not affect muscle strength. CONCLUSIONS Whey protein supplementation during diet-induced weight loss does not have clinically important therapeutic effects on muscle mass or strength in middle-aged postmenopausal women with obesity.
-
5.
Fructans Exacerbate Symptoms in a Subset of Children With Irritable Bowel Syndrome.
Chumpitazi, BP, McMeans, AR, Vaughan, A, Ali, A, Orlando, S, Elsaadi, A, Shulman, RJ
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2018;(2):219-225.e1
-
-
Free full text
-
Abstract
BACKGROUND & AIMS Dietary fructans exacerbate symptoms in some, but not all, adults with irritable bowel syndrome (IBS). We sought to determine whether fructans worsen symptoms in children with IBS and whether clinical and psychosocial factors, and/or gas production, can identify those who are fructan sensitive. METHODS We performed a double-blind placebo-controlled (maltodextrin) cross-over trial of 23 children with IBS, based on pediatric Rome III criteria, from September 2014 through December 2016. At baseline, participants completed 1-week pain and stool diaries and a 3-day food record and psychosocial factors (depression, anxiety, and somatization) were measured. Subjects were randomly assigned to groups that were provided meals for 72 hours containing either fructans or maltodextrin (0.5 g/kg; maximum, 19 g). Following a washout period of 10 days or more, the subjects received the meal they were not given during the first study period (crossed over). Gastrointestinal symptoms and breath hydrogen and methane production were captured during each meal period. Fructan sensitivity was defined as an increase of 30% or more in abdominal pain frequency following fructan ingestion. RESULTS Subjects had more mean episodes of abdominal pain/day during the fructan-containing diet (3.4 ± 2.6) vs the maltodextrin-containing diet (2.4 ± 1.7) (P < .01), along with more severe bloating (P < .05) and flatulence (P = .01). Hydrogen (but not methane) production was greater while subjects were on the fructan-containing diet (617 ± 305 ppm∗h) than the maltodextrin-containing diet (136 ± 78 ppm*h) (P < .001). Eighteen subjects (78.2%) had more frequent abdominal pain while on the fructan-containing diet and 12 (52.2%) qualified as fructan sensitive. We found no difference between fructan-sensitive and fructan-insensitive subjects in baseline abdominal pain or bowel movement characteristics, dietary intake, psychosocial parameters, IBS subtype, or gas production. CONCLUSIONS In a randomized controlled trial of children with IBS, we found fructans to exacerbate several symptoms. However, fructan sensitivity cannot be identified based on baseline gastrointestinal symptoms, dietary intake, psychosocial factors, or gas production. Clinicaltrials.gov no: NCT02842281.
-
6.
Effect of perioperative oral nutritional supplementation in malnourished patients who undergo gastrectomy: A prospective randomized trial.
Kong, SH, Lee, HJ, Na, JR, Kim, WG, Han, DS, Park, SH, Hong, H, Choi, Y, Ahn, HS, Suh, YS, et al
Surgery. 2018;(6):1263-1270
Abstract
BACKGROUND The aim of this study was to examine the effect of a perioperative oral nutritional supplement in malnourished patients who undergo gastrectomy. METHODS Patients who were determined as being moderately or severely malnourished according to a patient-generated subjective global assessment or who had a body mass index <18.5, were enrolled. The oral nutritional supplement group received 500 mL/d of standard oral nutritional supplement for 2 weeks before gastrectomy and for 4 weeks postoperatively. The primary endpoint was postoperative complications (Clavien-Dindo classification ≥II). The secondary endpoints included body weight changes, biochemical parameters, and quality of life survey results. RESULTS A total of 127 patients (65 in the oral nutritional supplement group and 62 in the control group) were enrolled. The complication rates were not significantly different (29.2% versus 37.1%, P = .346). However, the incidences of overall complications, complications persisting until postoperative week 3 or 5, and severe complications (grade ≥IIIa) were significantly lower in the oral nutritional supplement group for patients with patient-generated subjective global assessment grade C. Total lymphocyte counts were significantly higher in the oral nutritional supplement group at postoperative weeks 3 and 5. For most patients, oral nutritional supplement was well tolerated preoperatively. However, only 26.2% and 50.8% of the patients in the oral nutritional supplement group could consume >250 mL/d of oral nutritional supplement postoperatively during the 2nd and 4th weeks, respectively. CONCLUSIONS The routine application of perioperative oral nutritional supplement is not recommended for malnourished patients receiving gastrectomy. However, perioperative standard oral nutritional supplement administration may reduce the incidence, severity, and duration of complications after gastrectomy in severely malnourished patients (patient-generated subjective global assessment grade C).
-
7.
The Effects of a Korean Ginseng, GINST15, on Hypo-Pituitary-Adrenal and Oxidative Activity Induced by Intense Work Stress.
Flanagan, SD, DuPont, WH, Caldwell, LK, Hardesty, VH, Barnhart, EC, Beeler, MK, Post, EM, Volek, JS, Kraemer, WJ
Journal of medicinal food. 2018;(1):104-112
Abstract
The effect of GINST15, an enzyme fermented ginseng supplement, on hormonal and inflammatory responses to physical stress in humans is unknown. The purpose of this investigation was to examine the constitutive and stress-induced effects of GINST15 supplement on hypo-pituitary-adrenal (HPA) and antioxidant activity in addition to muscle damage. Ten women (age: 38.7 ± 7.8 years; height: 163.81 ± 4.4 cm; body mass 76.0 ± 11.6 kg) and nine men (age: 41.2. ± 9.7 years; height: 177.4 ± 5.3 cm; body mass: 88.5 ± 5.0 kg) participated in a double-blinded, placebo-controlled, counterbalanced within-group study. Participants completed three 14-day treatment cycles with different doses (high: 960 mg; low: 160 mg; placebo: 0 mg) separated by a 1-week washout period. At the end of treatment, physical stress was imposed with intense resistance exercise work stress. Participants provided blood at rest and various time points after exercise (immediately [IP], 30 min [30], 60 min [60], 24 h [+24HR]). Cortisol (CORT), superoxide dismutase (SOD), total glutathione, nonspecific antioxidant activity, total antioxidant power (TAP), and creatine kinase were measured. GINST15 supplementation produced stress-inducible dose-dependent reductions in circulating cortisol and increased enzymatic and nonspecific antioxidant activity. Twenty-four hours after intense exercise, a high dose GINST15, a bioactive ginsenoside metabolite, significantly reduces muscle damage and HPA responses to physical stress in humans; these effects may result from increased antioxidant expression.
-
8.
Claimed effects, outcome variables and methods of measurement for health claims on foods related to the gastrointestinal tract proposed under regulation (EC) 1924/2006.
Biasini, B, Marchi, L, Angelino, D, Bedogni, G, Zavaroni, I, Pruneti, C, Galli, D, Mirandola, P, Vitale, M, Dei Cas, A, et al
International journal of food sciences and nutrition. 2018;(7):771-804
-
-
Free full text
-
Abstract
Most of the requests of authorisation to the use of health claims pursuant to Regulation EC 1924/2006 related to the gastrointestinal (GI) tract have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of an insufficient substantiation of the claimed effect (CE). The present manuscript refers to the collection, collation and critical analysis of outcome variables (OVs) and methods of measurement (MMs) related to the GI tract compliant with Regulation 1924/2006. The critical evaluation of OVs and MMs was based on the literature review, with the final aim of defining their appropriateness in the context of a specific CE. The results obtained are relevant for the choice of the best OVs and MMs to be used in randomised controlled trials aimed to substantiate the claims on the GI tract. Moreover, the results can be used by EFSA for updating the guidance for the scientific requirements of such health claims.
-
9.
Intake of 25-Hydroxyvitamin D3 Reduces Duration and Severity of Upper Respiratory Tract Infection: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Shimizu, Y, Ito, Y, Yui, K, Egawa, K, Orimo, H
The journal of nutrition, health & aging. 2018;(4):491-500
-
-
Free full text
-
Abstract
OBJECTIVES This study aimed to assess the effect of 25-hydroxyvitamin D3 (25OHD) which is a hydroxide of vitamin D3 ingestion on upper respiratory tract infection (URTI). DESIGN AND SETTING A prospective, randomized, double-blind, placebo-controlled study was performed from December 2015 to September 2016 in the Nihonbashi Egawa Clinic, Kei Medical Office TOC Building Medical Clinic, and Medical Corporation Kaiseikai Kita-Shinyokohama Medical Clinic, in Japan. PARTICIPANTS Four hundred twenty eight participants aged 45-74 years were screened by their serum 25-hydoroxyvitamin D concentration. INTERVENTION The participants were randomized to either 25OHD (10 μg/day) or placebo capsule, daily, for 16 consecutive weeks. MEASUREMENTS The primary outcome measure was the incidence proportion of URTI, and the secondary outcome measures were the physical severity score, the quality-of-life (QOL) score, the duration of URTI, and the incidence proportion of new URTI events every four weeks. Data were collected using cold diary Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) during the intervention. RESULTS Of 428 participants screened, 252 with serum 25-hydroxyvitamn D levels were deficient or insufficient (75 nmol/L or less) were enrolled in this study. Of these, 105 placebo and 110 25OHD group subjects completed the study. For the incidence proportion of URTI, no effect of 25OHD intake was observed. On the other hand, the duration of URTI was shorter in the 25OHD (P = 0.061) compared to placebo. For the incidence proportion of URTI every four weeks, the incidence of new URTI was decreased in both groups over the time of intake. However, when the 25OHD and the placebo were compared, a decrease in the incidence proportion of URTI was seen earlier in the 25OHD. When the total physical severity score and the total QOL score during the study were assessed, they both were significantly improved in the 25OHD compared to placebo. CONCLUSIONS The intake of 25OHD may reduce the duration of URTI, the physical severity, and the QOL when suffering from URTI.
-
10.
The beneficial effect of probiotics as a supplementary treatment in drug-resistant epilepsy: a pilot study.
Gómez-Eguílaz, M, Ramón-Trapero, JL, Pérez-Martínez, L, Blanco, JR
Beneficial microbes. 2018;(6):875-881
Abstract
Epilepsy is a neurological disease with high global prevalence. Despite the range of drug-based treatments currently available to control the condition, one in 3 patients experiences epileptic seizures. Therapeutic alternatives for these patients include the ketogenic diet, surgery or the cerebral implantation of neurostimulators; however these are benefits with limits. The target of this study is to find a new complementary treatment for these patients, studying the effectiveness of probiotics for controlling epileptic seizures in patients with drug-resistant epilepsy. A prospective study was designed in which a group of patients with drug-resistant epilepsy was administered a probiotic mixture for 4 months. Patients were assessed before and after taking the probiotics; among other variables, number of seizures and patients' quality of life (QOLIE-10) were monitored. Levels of cD-14, interleukin 6, and γ-aminobutyric acid were also analysed throughout the study. 45 patients were included in the study. In an intention-to-treat analysis, 28.9% of all patients displayed a greater than 50% reduction in the number of seizures (the parameter required in clinical trials). A significant improvement was also observed in patients' quality of life. We found that probiotics may be an option for supplementary therapy. Since the use of probiotics is safe, they may contribute to improving seizure control, and therefore quality of life, in patients with drug-resistant epilepsy. The study has been registered in https://clinicaltrials.gov with number NCT03403907.