METHODS: A 24 h plaque re-growth, double-blinded, randomized crossover trial was carried out. Participants (n = 14) randomly rinsed with test formulation, 0.12% chlorhexidine (control) and placebo mouthwashes for 24 h. A week before the trial, all participants received scaling, polishing and oral hygiene education. On the trial day, the participants received polishing at baseline and rinsed with 15 ml of randomly allocated mouthwash twice daily without oral hygiene measures. After 24 h, plaque index was scored and then the participants entered a 6-days washout period with regular oral hygiene measures. The same protocol was repeated for the next 2 mouthwashes.
RESULTS: The results were expressed as mean (±SD) plaque index. The test mouthwash (0.931 ± 0.372) significantly reduced plaque accumulation when compared with placebo (1.440 ± 0.498, p 0.0167).
CONCLUSIONS: The test mouthwash has an anti-plaque effect for a 24 h period. Longer-term clinical studies are highly encouraged to investigate its anti-plaque effect for longer periods.
TRIAL REGISTRATION: This study was registered in ClinicalTrials.gov as NCT02624336 in December 3, 2015.
Methods: The present double blinded randomized clinical trial was conducted on fifty subjects, divided into groups A and B. Illicium verum mouthwash (group A) and placebo (group B) were provided to subjects for 21 days; after 14 days, washout period mouthwashes were switched as per crossover design between groups for 21 days. The gingival index (GI), papillary bleeding index (PBI), and oral microbial count were recorded at each stage of study.
Results: The significant intragroup difference was observed, before crossover in group A and after crossover in group B for GI, PBI, and oral microbial count at different stages of study. On comparing both group A and group B at the first and second follow-up for GI, PBI, and oral microbial count, a statistically significant difference (p < 0.05) was observed. A statistically highly significant mean intergroup and intragroup difference was seen for all the clinical parameters at different stages of study.
Conclusion: The study revealed that the Illicium verum/star anise has potent antibacterial, anti-inflammatory, and astringent properties.
METHODS: This was a randomized crossover trial in a simulated clinical setting to compare the SÜPEVAC unit with standard hospital wall suction. Twenty-two fellows of the Australasian College for Emergency Medicine, the Australian and New Zealand College of Anaesthetists, or the College of Intensive Care Medicine were recruited. Outcomes were assessed via a structured survey and measuring the time to view the glottis.
RESULTS: This study found there was no significant difference between the SÜPEVAC unit and wall suction with regard to suction time (P = .762; 95% confidence interval, -0.683 to 0.338) or qualitative assessment via the survey.
CONCLUSIONS: The SÜPEVAC unit is comparable with wall suction in a clinical setting. Further research is warranted.
METHODS: A cross-over, randomised study was carried out on 40 individuals (11 males and 29 females) aged 21 to 30 years. The rate of reading and reading accuracy was calculated with and without ChromaGen blue filter lens in all subjects. Wilkins Rate of Reading Test was used to measure the rate of reading and reading accuracy. Contrast sensitivity was also evaluated by using with and without the ChromaGen blue filter lens.
RESULTS: The mean rate of reading with and without ChromaGen blue filter lens was 160.58±16.03 words per minute and 150.52±15.66 words per minute respectively, with significant difference of p<0.001. The mean of reading accuracy (words correctly read per minute) in subjects, with ChromaGen blue filter was 149.30±0.79 words and without using filter lens was 148.53±1.11 words and found to be significant (p<0.001). There was no significant difference in the contrast sensitivity between subjects with and without the ChromaGen blue filter lens (p=0.083). No significant correlation was noted between the reading speed with age, spherical equivalent, contrast sensitivity, and reading accuracy.
CONCLUSION: This study concludes that there was an increase of 6.68% in the rate of reading and improvement of 0.52% in accuracy among subjects with ChromaGen blue filter lens.
MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods.
RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects.
CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.
METHODS: Using a randomized, crossover and double-blinded design, 15 men and 15 women with metabolic syndrome consumed high-fat meals enriched with SFA, MUFA or n-6 PUFA, or a low-fat/high-sucrose (SUCR) meal. C-peptide, insulin, glucose, gastrointestinal peptides and satiety were measured up to 6 h.
RESULTS: As expected, SUCR meal induced higher C-peptide (45 %), insulin (45 %) and glucose (49 %) responses compared with high-fat meals regardless of types of fatty acids (P < 0.001). Interestingly, incremental area under the curve (AUC0-120min) for glucagon-like peptide-1 was higher after SUCR meal compared with MUFA (27 %) and n-6 PUFA meals (23 %) (P = 0.01). AUC0-120min for glucose-dependent insulinotropic polypeptide was higher after SFA meal compared with MUFA (23 %) and n-6 PUFA meals (20 %) (P = 0.004). Significant meal x time interaction (P = 0.007) was observed for ghrelin, but not cholecystokinin and satiety.
CONCLUSIONS: The amount of fat regardless of the types of fatty acids affects insulin and glycemic responses. Both the amount and types of fatty acids acutely affect the gastrointestinal peptide release in metabolic syndrome subjects, but not satiety.
OBJECTIVE: To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects.
METHODS: Using a crossover design, randomized controlled trial in abdominally overweight men and women, we compared the effects of substitution of 7% energy as carbohydrate or MUFA for SAFA for a period of 6 weeks each. Fasting and postprandial blood samples in response to corresponding SAFA, carbohydrate, or MUFA-enriched meal-challenges were collected after 6 weeks on each diet treatment for the assessment of outcomes.
RESULTS: As expected, postprandial nonesterified fatty acid suppression and elevation of C-peptide, insulin and glucose secretion were the greatest with high-carbohydrate (CARB) meal. Interestingly, CARB meal attenuated postprandial insulin secretion corrected for glucose response; however, the insulin sensitivity and disposition index were not affected. SAFA and MUFA had similar effects on all markers except for fasting glucose-dependent insulinotropic peptide concentrations, which increased after MUFA but not SAFA when compared with CARB.
CONCLUSION: In conclusion, a 6-week lower-fat/higher-carbohydrate (increased by 7% refined carbohydrate) diet may have greater adverse effect on insulin secretion corrected for glucose compared with isocaloric higher-fat diets. In contrast, exchanging MUFA for SAFA at 7% energy had no appreciable adverse impact on insulin secretion.
SUBJECTS/METHODS: Thirty metabolic syndrome subjects (15 men and 15 women) were recruited to a randomized, double-blinded and crossover study. The subjects were administered a single dose of 200 mg or 400 mg γδ-T3 emulsions or placebo incorporated into a glass of strawberry-flavored milkshake, consumed together with a high-fat muffin. Blood samples were collected at 0, 5, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min after meal intake.
RESULTS: Plasma vitamin E levels reflected the absorption of γδ-T3 after treatments. Postprandial changes in serum C-peptide, serum insulin, plasma glucose, triacylglycerol, non-esterified fatty acid and adiponectin did not differ between treatments, with women displaying delayed increase in the aforementioned markers. No significant difference between treatments was observed for plasma cytokines (interleukin-1 beta, interleukin-6 and tumor necrosis factor alpha) and thrombogenic markers (plasminogen activator inhibitor type 1 and D-dimer).
CONCLUSIONS: Supplementation of a single dose of γδ-T3 did not change the insulinemic, anti-inflammatory and anti-thrombogenic responses in metabolic syndrome subjects.
METHOD: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2-period crossover study with a washout period of 7 days. Paracetamol/Orphenadrine tablets were administered after a 10-h fast. Blood samples for pharmacokinetic analysis were collected at scheduled time intervals prior to and up to 72 h after dosing. Blood samples were centrifuged, and separated plasma were kept frozen (- 15 °C to - 25 °C) until analysis. Plasma concentrations of orphenadrine and paracetamol were quantified using liquid-chromatography-tandem mass spectrometer using diphenhydramine as internal standard. The pharmacokinetic parameters AUC0-∞, AUC0-t and Cmax were determined using plasma concentration time profile for both preparations. Bioequivalence was assessed according to the ASEAN guideline acceptance criteria for bioequivalence which is the 90% confidence intervals of AUC0-∞, AUC0-t and Cmax ratio must be within the range of 80.00-125.00%.
RESULTS: There were 28 healthy subjects enrolled, and 27 subjects completed this trial. There were no significant differences observed between the AUC0-∞, AUC0-t and Cmax of both test and reference preparations in fasted condition. The 90% confidence intervals for the ratio of AUC0-t (100.92-111.27%), AUC0-∞ (96.94-108.08%) and Cmax (100.11-112.50%) for orphenadrine (n = 25); and AUC0-t (94.29-101.83%), AUC0-∞ (94.77-101.68%) and Cmax (87.12-101.20%) for paracetamol (n = 27) for test preparation over reference preparation were all within acceptable bioequivalence range of 80.00-125.00%.
CONCLUSION: The test preparation is bioequivalent to the reference preparation and can be used interchangeably.
TRIAL REGISTRATION: NMRR- 17-1266-36,001; registered and approved on 12 September 2017.
METHODS: DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m2, and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694.
FINDINGS: Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m2 (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA1c was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m2 (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred.
INTERPRETATION: 6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes.
FUNDING: AstraZeneca.
METHODS: Eight cyclists exercised at three submaximal intensities before completing a TTE100% at sea-level (SEA) and at 1657 m of altitude (ALT), with pre-exercise consumption of 1000 mg of POMx or a placebo (PLAC) in a randomized, double-blind, crossover design. Data were analysed using a three way (treatment x altitude x intensity) or two-way (treatment x altitude) repeated measures ANOVA with a Fisher's LSD post-hoc analysis. Significance was set at p ≤ 0.05. The effect size of significant interactions was calculated using Cohen's d.
RESULTS: TTE100% performance was reduced in ALT but was not influenced by POMx (p > 0.05). Plasma NO3- were 10.3 μmol greater with POMx vs. PLAC (95% CI, 0.8, 19.7,F1,7 = 7.83, p 0.05). Submaximal VO2 values were not affected by POMx (p ≥ 0.05).
CONCLUSIONS: The restoration of SEA VO2 values at ALT is likely driven by the high polyphenol content of POMx, which is proposed to improve nitric oxide bioavailability. Despite an increase in VO2, no change in exercise performance occurred and therefore this study does not support the use of POMx as an ergogenic supplement.