scholarly journals Riboflavin Bioavailability Varies with Milk Type and Is Altered in Self-Reported Dairy Intolerance States (P24-012-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Pankaja Sharma Ghimeray ◽  
Aahana Shrestha ◽  
Josefin Karlström ◽  
Jakob Martinson ◽  
Jimmy Nilsson ◽  
...  
Keyword(s):  
High Performance ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Double Blind ◽  
Funding Sources ◽  
Increased Risk ◽  
Treatment Interaction ◽  
B Vitamin ◽  
Milk Ingestion ◽  
Conventional Milk

Abstract Objectives Riboflavin, the most abundant and bioavailable B-vitamin present in milk, is highly sensitive to degradation; thus, riboflavin content may vary depending on processing or the type of milk. Milk is one of the richest dietary source of riboflavin, making sufficient intake more challenging for those with dietary restrictions, such as lactose and dairy intolerant populations. Additionally, these individuals experience altered digestive function following dairy intake which may alter the bioavailability of ingested nutrients. Therefore, this study investigated whether B-vitamin bioavailability from milk is altered by milk type or processing, and whether this bioavailability is diminished in individuals with lactose and dairy intolerance. Methods The study recruited self-reported milk tolerant and intolerant young women (n = 40). All participants underwent a lactose challenge (50 g) for classification as dairy tolerant (DT, n = 10), lactose intolerant (LI, n = 10) or non-lactose dairy intolerant (NLDI, n = 20; self-reported dairy intolerance, but lactose tolerant). All participants ingested 750 mL of conventional milk (CM), lactose-free conventional milk (LF-CM) and a2 MilkTM (A2M) in a double-blind randomized crossover controlled trial. Plasma samples collected at fasting and hourly until 3 hours were analyzed for B-vitamins using high performance liquid chromatography coupled with mass spectrometry. Results Only plasma riboflavin concentrations increased following all types of milk ingestion in all groups. Riboflavin concentrations were higher post CM (P < 0.05) at all postprandial time points than LF-CM and A2M (time x treatment interaction, P = 0.010) in all groups; however, the incremental area under the curve (iAUC) following CM was only higher than A2M (P = 0.001) but not LF-CM. NLDI subjects had lower postprandial riboflavin concentrations and iAUC (group x treatment interaction, P = 0.040; iAUC P = 0.049) than LI individuals. Conclusions Riboflavin from CM is more bioavailable than LF-CM or A2M indicating that riboflavin content depends on the milk type or processing. However, regardless of milk type, decreased bioavailability may put NLDI individuals at increased risk of riboflavin inadequacy compared to LI people. Funding Sources AgResearch, The a2 Milk Company, High Value Nutrition, Riddet Institute.

scholarly journals Neurological Development and Iron Supplementation in Healthy Late-Preterm Neonates: A Randomized Double-Blind Controlled Trial

2021 ◽  
Author(s):  
Rita Luciano ◽  
Domenico Marco Romeo ◽  
Giuseppina Mancini ◽  
Serena Sivo ◽  
Carolina Dolci ◽  
...  
Keyword(s):  
Placebo Group ◽  
Iron Supplementation ◽  
Controlled Trial ◽  
Preterm Neonates ◽  
Neurological Development ◽  
Double Blind ◽  
Neurological Outcomes ◽  
Increased Risk ◽  
The Mean

Abstract ObjectiveLate-preterm infants (LPT) are at increased risk for long-term neurodevelopmental sequelaeand iron deficiency. Aim of the study is to assess the positive effect of iron supplementation on neurological development in healthy LPT.DesignWe designed a perspective, randomized placebo-controlled double-blind trial. The newborns were randomized in two groups: thirty-three patients received martial prophylaxis, thirty-three placebo. Every patient was assessed using the Griffith Mental Development Scales (GMDS)-II edition at 12 months of post-conceptional age.SettingThe study was performed at the Neonatology Unit of Fondazione Policlinico Gemelli IRCCS.PatientsSixty-six healthy LPT infants born between 340⁄7 and 366⁄7 weeks of Gestational Age were enrolled in the study.InterventionsOne group received martial prophylaxis from the third week of life to six months of post-conceptional age (2 mg/kg/day of iron pidolate), the other received placebo.Main outcome measuresFifty-two of the enrolled infants were assessed using the GMDS at 12-month of post-conceptional age. Statistical analysis of the mean scores of the Griffith subscales was performed.ResultsThere was a difference in the mean Developmental Quotient (DQ) (p<0.01) between the two groups: Iron Group mean DQ 121.45+10.53 vs Placebo Group mean DQ 113.25+9.70. Moreover, mean scores of the Griffith subscales A, B and D showed significant differences between the two Groups (scale A p<0.05, scale B p<0.02, scale D p<0.01 respectively).ConclusionsOur data show that newborns who received iron supplementation during the first six months of life achieved significantly better neurological outcomes at GMDS than Placebo group.

Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin

2019 ◽  
Vol 75 (3) ◽  
pp. 709-717 ◽  
Author(s):  
Naouale Maataoui ◽  
Céline Langendorf ◽  
Fatou Berthe ◽  
Jumamurat R Bayjanov ◽  
Willem van Schaik ◽  
...  
Keyword(s):  
Placebo Group ◽  
Severe Acute Malnutrition ◽  
Controlled Trial ◽  
Acute Malnutrition ◽  
Double Blind ◽  
Adjusted Risk ◽  
Malnourished Children ◽  
Nutritional Recovery ◽  
Adjusted Risk Ratio ◽  
Increased Risk

Abstract Objectives Routine amoxicillin for children with uncomplicated severe acute malnutrition raises concerns of increasing antibiotic resistance. We performed an ancillary study nested within a double-blind, placebo-controlled trial in Niger testing the role of routine 7 day amoxicillin therapy in nutritional recovery of children 6 to 59 months of age with uncomplicated severe acute malnutrition. Methods We screened 472 children for rectal carriage of ESBL-producing Enterobacteriaceae (ESBL-E) as well as their household siblings under 5 years old, at baseline and Week 1 (W1) and Week 4 (W4) after start of therapy, and characterized strains by WGS. ClinicalTrials.gov: NCT01613547. Results Carriage in index children at baseline was similar in the amoxicillin and the placebo groups (33.8% versus 27.9%, P = 0.17). However, acquisition of ESBL-E in index children at W1 was higher in the amoxicillin group than in the placebo group (53.7% versus 32.2%, adjusted risk ratio = 2.29, P = 0.001). Among 209 index and sibling households possibly exposed to ESBL-E transmission, 16 (7.7%) had paired strains differing by ≤10 SNPs, suggesting a high probability of transmission. This was more frequent in households from the amoxicillin group than from the placebo group [11.5% (12/104) versus 3.8% (4/105), P = 0.04]. Conclusions Among children exposed to amoxicillin, ESBL-E colonization was more frequent and the risk of transmission to siblings higher. Routine amoxicillin should be carefully balanced with the risks associated with ESBL-E colonization.

scholarly journals Neurologic Safety of Etomidate-Based Sedation during Upper Endoscopy in Patients with Liver Cirrhosis Compared with Propofol: A Double-Blind, Randomized Controlled Trial

2020 ◽  
Vol 9 (8) ◽  
pp. 2424
Author(s):  
Jang Han Jung ◽  
Bomi Hyun ◽  
Jin Lee ◽  
Dong Hee Koh ◽  
Jung Hee Kim ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Early Discharge ◽  
Double Blind ◽  
Increased Risk ◽  
Overt Hepatic Encephalopathy ◽  
Secondary Endpoints ◽  
Number Connection Test ◽  
Severe Degree

(1) Background: Although etomidate-based sedation is an effective and safe protocol in endoscopic procedures, there is a lack of evidence regarding the safety of etomidate in patients with liver cirrhosis (LC). This study aimed to compare the neurologic safety and efficacy of etomidate and propofol for endoscopic sedation in patients with LC. (2) Methods: From December 2017 to December 2019, consecutive cirrhotic patients who underwent sedative endoscopy using either etomidate or propofol were randomly recruited. The primary endpoint was the number connection test (NCT), and the secondary endpoints included factors for the safety of sedatives during endoscopy. (3) Results: 63 patients were enrolled in each of the etomidate and propofol groups. The NCT times were significantly lower in the etomidate group than in the propofol group. Furthermore, severe or very severe degree of encephalopathy was higher in the propofol group but was not significantly different. Pharmacological properties and the overall incidence of respiratory and cardiovascular events did not differ significantly between the groups. (4) Conclusion: Etomidate-based sedation exacerbates neither subclinical nor overt hepatic encephalopathy. It guarantees efficacies similar to those of propofol regarding rapid sedation, fast recovery, and early discharge, with no increased risk of adverse respiratory or cardiovascular events in patients with LC.

scholarly journals Comparison of the Acute Postprandial Circulating B-Vitamin and Vitamer Responses to Single Breakfast Meals in Young and Older Individuals: Preliminary Secondary Outcomes of a Randomized Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2893 ◽  
Author(s):  
Pankaja Sharma ◽  
Nicola Gillies ◽  
Shikha Pundir ◽  
Chantal A. Pileggi ◽  
James F. Markworth ◽  
...  
Keyword(s):  
High Performance ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Age Groups ◽  
Pantothenic Acid ◽  
B Vitamins ◽  
Flavin Mononucleotide ◽  
Older Individuals ◽  
Minimal Impact ◽  
B Vitamin

B-vitamin deficiency is common in ageing populations either due to altered dietary habits or altered digestive and metabolic functions. There is limited data on the acute circulating concentrations of B-vitamins and their various forms (vitamers), following ingestion of realistic meals. This study compared the acute circulating B-vitamin and vitamer responses to either an energy-dense (ED) or a nutrient-dense (ND) breakfast meal, consumed in a randomized cross-over sequence, in older and younger adults (n = 15 and 15, aged 67.3 ± 1.5 and 22.7 ± 0.5 years (mean ± SEM), respectively). Eleven differing B-vitamins and vitamers were determined in plasma samples by ultra-high-performance liquid chromatography-tandem mass spectrometry, in the fasting and postprandial state (hourly for 5 h). While postprandial thiamine concentration increased following both meals, riboflavin increased only following a ND meal in both age groups. Many vitamins including nicotinic acid, pantothenic acid, pyridoxal, pyridoxamine, pyridoxal-5’phosphate, and 4-pyridoxic acid remained unaltered, and flavin mononucleotide (FMN), nicotinamide and nicotinuric acid concentrations reduced following both meals. Biological age and food composition had minimal impact on postprandial B-vitamin concentrations, yet the differences between the ED and ND meals for riboflavin highlight the importance of riboflavin intake to achieve adequacy.

scholarly journals CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e021000 ◽  
Author(s):  
Dan Siskind ◽  
Nadia Friend ◽  
Anthony Russell ◽  
John J McGrath ◽  
Carmen Lim ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Body Weight ◽  
Weight Gain ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Double Blind ◽  
Human Research Ethics ◽  
Increased Risk ◽  
Point Body ◽  
Randomised Controlled

IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

scholarly journals Impact of Acute and Chronic Red Beetroot Juice Consumption on Postprandial Endothelial Function and Levels of Nitrate/Nitrite in Plasma and Saliva (P06-113-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Nicole Litwin ◽  
Hannah Van Ark ◽  
Shannon Hartley ◽  
Kiri Michell ◽  
Allegra Vazquez ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Chronic Exposure ◽  
Reactive Hyperemia ◽  
Beetroot Juice ◽  
Double Blind ◽  
Funding Sources ◽  
Time Treatment ◽  
Treatment Interaction ◽  
Agricultural Experiment ◽  
Acute And Chronic Exposure

Abstract Objectives High-fat meal (HFM) consumption has been shown to impair postprandial endothelial function. Red beetroot juice (RBJ) contains polyphenols, betalains, carotenoids, ascorbic acid, and inorganic nitrate, and has been shown to improve endothelial function. This study investigated the acute and chronic effects of RBJ and its bioactive components on postprandial endothelial function. We hypothesized that a HFM would impair postprandial endothelial function, and that RBJ would attenuate this, in part, through increased circulating nitrate/nitrite (NOx) levels. Methods A 4-period randomized, double-blind, placebo-controlled crossover clinical trial was conducted. Fifteen overweight and obese middle-aged/older men and postmenopausal women underwent baseline (T0) assessment of endothelial function (via reactive hyperemia index, RHI) and collection of blood and saliva. Participants consumed one of the following 70 mL treatments (acute exposure): 1) RBJ, 2) nitrate-free RBJ (NF-RBJ), 3) placebo + nitrate (PBO + NIT), and 4) placebo (PBO), followed by a HFM. RHI was measured at 4 hours (T4) post-HFM, and blood and saliva were collected at 1 hour (T1), 2 hours (T2), and T4. Participants then consumed treatments daily for 4 weeks (chronic exposure), and all assessments were repeated before/after the HFM but without consuming treatments. Results No significant time or treatment effects were observed for RHI. Following acute and chronic exposure to RBJ and PBO + NIT, plasma NOx levels were higher at T0 (chronic only), T1, T2, and T4 compared to PBO and NF-RBJ (P < 0.001). After chronic exposure to RBJ, saliva NOx levels were higher at T0, T1, T2, and T4 compared to PBO and NF-RBJ (P < 0.001). Saliva NOx levels for PBO + NIT were higher than both PBO and NF-RBJ at T0 (P < 0.001), but only higher than NF-RBJ at T1 (P = 0.02), and higher than PBO at T4 (P = 0.02). Additionally, there was a time*treatment interaction for plasma and saliva NOx levels following 4 weeks of daily exposure to RBJ and PBO + NIT (P < 0.001). Conclusions The preliminary results of this study suggest that HFM consumption does not significantly impair postprandial endothelial function in this population. In addition, acute and chronic RBJ exposure does not significantly improve endothelial function despite increases in plasma and saliva NOx. Funding Sources Colorado Agricultural Experiment Station, NIFA, USDA.

scholarly journals Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial

2020 ◽  
Vol 4 (11) ◽  
Author(s):  
Giulio R Romeo ◽  
Junhee Lee ◽  
Christopher M Mulla ◽  
Youngmin Noh ◽  
Casey Holden ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Cost Effective ◽  
Tolerance Test ◽  
Controlled Clinical Trial ◽  
Oral Glucose ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Favorable Safety

Abstract Context The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon’s glucose-lowering properties can be leveraged in individuals with prediabetes. Objective The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes. Design, Setting, Participants, and Intervention This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks. Main Outcome Measures Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT. Results From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL (P &lt; .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG (P &lt; .001) and of the 2-hour PG of the OGTT (P &lt; .05). There were no serious adverse events in either study group. Conclusions In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon’s effects on the rate of progression from prediabetes to T2D.

scholarly journals 0809 A Randomized Double-blind, Placebo Controlled Trial With Cross-over, To Assess The Efficacy Of Correcting Vitamin D Deficiency In Improving The Symptoms Of Restless Legs Syndrome (RLS)

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A307-A308
Author(s):  
J Wong ◽  
D Gupta ◽  
A Nadhim ◽  
S Bhat ◽  
P Polos
Keyword(s):  
Vitamin D ◽  
Iron Deficiency ◽  
Vitamin D Deficiency ◽  
Controlled Trial ◽  
Activity Count ◽  
Double Blind ◽  
Vitamin D Levels ◽  
Effect Of Treatment ◽  
B Vitamin

Abstract Introduction Recent studies have shown an association of low Vitamin D levels and severity of RLS symptoms. However, effect of treatment of Vit D deficiency on RLS symptoms was not reported, nor were other exacerbating factors for RLS such as iron deficiency or OSA addressed in prior studies, but have been addressed in our study. Methods This is an ongoing study at the JFKMC Sleep Clinic. Eligible Patients with RLS include those with vitamin D 25,hydroxy deficiency (&lt;20 ng/ml), or insufficiency (&lt;30 ng/ml). Such patients will be enrolled in the study after comorbid conditions like iron deficiency and OSA have been adequately corrected. Randomization of the patients will be done by the JFK pharmacy so the patient and provider are blinded to the substance. Substance A or B could be either Vitamin D3 Capsule 50,000 IU, or placebo. Each patient takes A for 6 weeks and then crosses over to B for 6 weeks. Weekly iRLS questionnaires will be collected. Actiwatch Device, to assess activity count per minute, will be worn on the ankle at night for one week time periods: at baseline, at end of 6 weeks of taking A and then at the end of 6 weeks of taking B. Vitamin D levels will also be assessed after each course of supplementation and correlated with subjective and objective findings. Results Between July 7, 2019 to current, 50 consecutive patients seen in sleep clinic with RLS were assessed for vitamin D levels. Ages ranged from 23-86 years. 27 patients were female (54%). Two patients met inclusion criteria and have started their 13-week study. Conclusion This study will help to establish the role of Vitamin D deficiency as a risk factor for RLS, independent of ferritin levels, and comorbid OSA, in affected individuals. This may help to discover a potentially treatable form of RLS. Support No financial support.

Modafinil for fatigue associated with docetaxel-based chemotherapy: A randomized controlled trial.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 211-211
Author(s):  
Elizabeth J. Hovey ◽  
Paul L. De Souza ◽  
Gavin M. Marx ◽  
Phillip Parente ◽  
Tal Rapke ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Study Medication ◽  
Double Blind ◽  
Patients With Cancer ◽  
Parallel Group ◽  
Grade 3 ◽  
Chemotherapy Patients ◽  
Md Anderson

211 Background: Chemotherapy-induced fatigue is a common complaint for patients with cancer. We investigated whether modafinil, a psychostimulant, could reduce fatigue in patients on chemotherapy. Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel group study was conducted in patients with metastatic prostate or breast cancer suffering significant chemotherapy-related fatigue whilst undergoing docetaxel-based chemotherapy. Patients were enrolled at the start of their 3rdor subsequent cycles of docetaxel which was continued for up to four further cycles (defined here as ‘treatment periods’). Patients were randomized 2:1 to receive modafinil 200mg daily or placebo for 15 days during each treatment period. Fatigue was evaluated by the MD Anderson Symptom Inventory (MDASI). The primary endpoint was MDASI area under the curve (AUC) during the first 7 days of study medication for the first two treatment periods (possible range 0-70). Other validated tools were used to record disturbances in sleep, mood and functional status. Results: Eighty-three patients (65 with prostate cancer) were randomized and received at least one dose of study medication. The number of grade 3 or 4 adverse events (AEs) was 16/55 (29.1%) in the modafinil group and 5/28 (17.9%) in the placebo group. The toxicity profile was largely consistent with docetaxel-based chemotherapy and with previously reported AEs associated with modafinil use in the community; 11 AEs were possibly related to docetaxel; 1 to modafinil and 9 to neither treatment. Conclusions: Managing chemotherapy-related fatigue remains a major challenge. Despite not reaching the primary endpoint, there was a consistent trend towards improvement of chemotherapy-related fatigue in the modafinil arm. Further studies are needed to better understand the clinical implications of these findings. Funding sanofi-aventis; Study ID NCT00917748 . [Table: see text]

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