Mono- and diglycerides improve lutein absorption in healthy adults: a randomised, double-blind, cross-over, single-dose study

2017 ◽  
Vol 118 (10) ◽  
pp. 813-821 ◽  
Author(s):  
Barbara J. Marriage ◽  
Jennifer A. Williams ◽  
Yong S. Choe ◽  
Kevin C. Maki ◽  
Mustafa Vurma ◽  
...  
Keyword(s):  
Single Dose ◽  
Peak Level ◽  
Study Data ◽  
Primary Objective ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Single Dose Study ◽  
High Oleic ◽  
Time To Peak

AbstractWith the association between increased carotenoid intake and lower risk of chronic diseases, the absorption of lutein from the diet becomes an important factor in its delivery and physiological action. The primary objective of this study was to gain an understanding of how a new formulation technology (mixture of mono- and diglycerides (MDG)), affected lutein absorption. Subjects (n24) were randomised in a cross-over, double-blind study to receive a single dose of 6 mg lutein (FloraGLO 20 %) provided as capsules containing either high-oleic safflower (SAF) oil or a MDG oil. Subjects receiving a single dose of lutein in MDG showed a significantly greater change from baseline (0 h) to 4, 6, 8, 12, 24, 48 and 336 h (P<0·05) and baseline adjusted AUC for plasma lutein at 48 and 336 h (P<0·001) as compared with subjects given lutein in SAF. Analysis of the 48 h absorption kinetics of lutein showed that the time to peak level of lutein (12 h) was the same for SAF and MDG groups, but the change in plasma lutein at 12 and 48 h were 129 and 320 % higher, respectively, for MDG compared with SAF. This difference continued as the adjusted AUC 0–48 and 0–336 h for the MDG group was 232 and 900 % higher, respectively, v. SAF. The study data show that by changing the lipid that is combined with a lutein supplement results in significant increases in lutein absorption in healthy adults.

Safety of intravenous (IV) NEPA and oral NEPA for prevention of CINV in patients (pts) with breast cancer (BC) receiving anthracycline/cyclophosphamide (AC) chemotherapy (CT).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11594-11594
Author(s):  
Lee S. Schwartzberg ◽  
Daniel Voisin ◽  
Giada Rizzi ◽  
Kamal Patel ◽  
Matti S. Aapro
Keyword(s):  
Single Dose ◽  
Safety Evaluation ◽  
Complete Response ◽  
Primary Objective ◽  
Double Blind Study ◽  
Infusion Site ◽  
Double Blind ◽  
Antiemetic Agent ◽  
Pivotal Study ◽  
Safety Population

11594 Background: NEPA, a combination antiemetic agent [NK1 receptor antagonist (RA) netupitant (oral) or fosnetupitant (IV) + 5-HT3RA palonosetron] offers 5-day CINV prevention with a single-dose. Unlike other IV NK1RAs, the fosnetupitant solution does not require a surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. In a Phase 3 study in pts receiving cisplatin-based CT, there were no infusion site or anaphylactic reactions related to IV NEPA. In contrast, hypersensitivity reactions and anaphylaxis have been reported with IV aprepitant, fosaprepitant and rolapitant, with the highest rate (35%) for fosaprepitant in the AC setting. This study (NCT03403712) evaluates the safety of IV NEPA in BC pts receiving repeat cycles of AC CT. Methods: This was a Phase 3b, double-blind study in females with BC naïve to highly/moderately emetogenic CT. Pts were randomized 1:1 to receive a single 30-min infusion of IV NEPA or a single oral NEPA capsule on Day 1, prior to AC. Oral dexamethasone was also given to all patients before CT. The primary objective was a safety evaluation of IV NEPA based primarily on treatment-emergent adverse events (TEAEs). No formal between groups statistical comparison was planned. Results: 402 pts were treated with IV NEPA or oral NEPA and included in the safety population. The AE profiles were similar for the two groups; cycle 1 results are reported (Table). Comparable complete response (no emesis, no rescue) rates were seen during the cycle 1 overall phase (0-120h) (73.0% IV NEPA, 77.2% oral NEPA). Conclusions: There were no infusion-site AEs related to IV NEPA and no anaphylaxis reported for either formulation. Consistent with the pivotal study, IV NEPA is safe and effective in pts receiving AC. As a simplified single-dose formulation, IV NEPA may be better tolerated than other NK1 RAs. Clinical trial information: NCT03403712. [Table: see text]

scholarly journals Randomized, Double-Blind Study in Healthy Adults to Assess the Boosting Effect of Vaqta or Havrix after a Single Dose of Havrix

2001 ◽  
Vol 32 (3) ◽  
pp. 396-401 ◽  
Author(s):  
B. A. Connor ◽  
J. Phair ◽  
D. Sack ◽  
D. McEniry ◽  
R. Hornick ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Adults ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind

The Effect of Warfarin Sodium on the Duration of Platelet Aggregation

1967 ◽  
Vol 18 (03/04) ◽  
pp. 766-778 ◽  
Author(s):  
H. J Knieriem ◽  
A. B Chandler
Keyword(s):  
Platelet Count ◽  
Placebo Group ◽  
Platelet Aggregation ◽  
Prothrombin Time ◽  
Platelet Rich Plasma ◽  
Healthy Adults ◽  
Double Blind Study ◽  
Double Blind ◽  
Warfarin Sodium

SummaryThe effect of the administration of warfarin sodium (Coumadin®) on the duration of platelet aggregation in vitro was studied. Coumadin was given for 4 consecutive days to 10 healthy adults who were followed over a period of 9 days. The duration of adenosine diphosphate-induced platelet aggregation in platelet-rich plasma, the prothrombin time, and the platelet count of platelet-rich plasma were measured. Four other healthy adults received placebos and participated in a double-blind study with those receiving Coumadin.Although administration of Coumadin caused a prolongation of the prothrombin time to 2 or 21/2 times the normal value, a decrease in the duration of platelet aggregation was not observed. In most individuals who received Coumadin an increase in the duration of platelet aggregation occurred. The effect of Coumadin on platelet aggregation was not consistently related to the prothrombin time or to the platelet count. In the placebo group there was a distinct relation between the duration of platelet aggregation and the platelet count in platelet-rich plasma.The mean increase in the duration of platelet aggregation when compared to the control value before medication with Coumadin was 37.7%. In the placebo group there was a mean increase of 8.4%. The difference between the two groups is significant (p <0.001). Increased duration of platelet aggregation also occurred in two individuals who received Coumadin over a period of 10 and 16 days respectively.

Single dose oral ranitidine improves MRCP image quality: a double-blind study

2007 ◽  
Vol 62 (1) ◽  
pp. 53-57 ◽  
Author(s):  
M.T. Bowes ◽  
D.F. Martin ◽  
A. Melling ◽  
D. Roberts ◽  
H.-U. Laasch ◽  
...  
Keyword(s):  
Single Dose ◽  
Image Quality ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind ◽  
Dose Oral

Consumption by Healthy Adults of Pasteurized Milk with a High Concentration of Bacillus cereus: A Double-Blind Study

1996 ◽  
Vol 59 (7) ◽  
pp. 723-726 ◽  
Author(s):  
LEO P. M. LANGEVELD ◽  
WILLEM A. VAN SPRONSEN ◽  
EMERENTIA C. H. VAN BERESTEIJN ◽  
SERVÉ H. W. NOTERMANS
Keyword(s):  
Bacillus Cereus ◽  
Healthy Adults ◽  
Double Blind Study ◽  
High Concentration ◽  
Healthy Human ◽  
Double Blind ◽  
Pasteurized Milk ◽  
Human Volunteers ◽  
Pure Cultures ◽  
Gastrointestinal Complaints

A double-blind experiment with 34 healthy human volunteers, aged between 20 and 60 years, was conducted to obtain information about the allowable concentration of B. cereus in pasteurized milk. During a period of 3 weeks the subjects were exposed to B. cereus naturally present in pasteurized milk following storage for 3 to 14 days at 7.5°C. Of 259 milk exposures, gastrointestinal complaints were observed in 18 cases. According to total numbers of B. cereus ingested per exposure the complaints per number of exposures were distributed as follows: &lt; 106: 5 in 132; 106 to 107: 2 in 32; 107 to 108 : 2 in 26; and &gt; 108: 9 in 69. Symptoms, however, were not typical of those caused by B. cereus. There was a weak significance (P ≤ 0.1) for symptoms when &gt; 108 B. cereus cells were ingested. Milk with 106 to 107 B. cereus cells per ml showed a very low diarrheal enterotoxin titer. Pure cultures of B. cereus strains isolated from samples with high B. cereus concentrations also showed a low production of enterotoxin. It can be concluded that for healthy adults the probability of become diseased from cold-stored pasteurized milk is small. From the results no evidence is obtained that B. cereus concentrations less than 105/ml will cause intoxication.

scholarly journals Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study)

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035177 ◽  
Author(s):  
Samina Ali ◽  
Manasi Rajagopal ◽  
Terry Klassen ◽  
Lawrence Richer ◽  
Christopher McCabe ◽  
...  
Keyword(s):  
Health Research ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Study Data ◽  
Primary Objective ◽  
Trial Methodology ◽  
Double Blind ◽  
Limb Injury ◽  
Oral Ibuprofen ◽  
Children's Pain

IntroductionMusculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children’s pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference.Methods and analysisUsing a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019.Ethics and disseminationThis study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant.Trial registration numberNCT03767933, first registered on 07 December 2018.

Sign in / Sign up

Export Citation Format

Share Document