Search

Summary Objective In this report, we investigated the effects of CitrusiM® (Citrus sinensis (L.) Osbeck dried extract) on body composition, defined in terms of two outcomes: percentage of lean mass and percentage of fat mass. Research methods & procedures A double-blind randomized experiment with overweight and obese volunteers was conducted in which the two variables were measured at baseline and three months afterwards. The treatment levels corresponded to three different daily doses of CitrusiM®: 0 mg (control), 0.5 g, and 1 g. All patients met with a nutritionist, and were given a standardized diet with their assigned treatments. At the end of three months, the intermediate outcomes of diet compliance (in percent) and amount of exercise (either none, low level, or high level) were recorded. The covariates that were collected for each subject were age, height, and sex. We analyzed the effects of the treatments on the two outcomes under a Bayesian framework of the Rubin Causal Model, and accounted for possible relationships between both diet compliance and exercise level and the three outcomes of interest in the analyses. Study registered under Research Ethics Committee of the Faculdade de Ciencias Medicas e da Saude de Juiz de For a (plataformabrasil.gov.br): Identifier no. 2.767.611. Results There was a statistically significant evidence that the treatment may increase lean mass and reduce fat mass. Conclusion A 3-month treatment with CitrusiM® (0.5 g or 1 g, daily) was able to increase lean mass, reduce fat mass, in the participants.

Background: Risperidone (RSP) is a benzisoxazole antipsychotic agent used to treat schizophrenia and other psychiatric illnesses in adults and children (including those with autism). After oral administration, RSP is completely absorbed from the gastrointestinal tract and undergoes hydroxylation to yield 9-hydroxyrisperidone (9-OH-RSP), an active metabolite that has a pharmacologic profile and potency similar to RSP. Objectives: The aims of this study were to compare the relative bioavailability of a pharmaceutical-equivalent (test) formulation with a reference formulation of oral RSP 2 mg, both available commercially on the Brazilian pharmaceutical market, and to generate data regarding the oral bioavailability of the tested drug in healthy Brazilian volunteers. Methods: This single-dose, randomized-sequence, open-label, 2-period crossover study was conducted in healthy Brazilian volunteers from August to December 2008. Subjects were randomly assigned to receive the test formulation followed by the reference formulation or vice versa, with a 30-day washout period between doses. Study drugs were administered after a 12-hour overnight fast. For pharmacokinetic analysis, blood samples were drawn at 0 (baseline), 0.25, 0.5, 1, 1.5, 3, 5, 8, 12, 24, 48, 72, 96, and 120 hours after administration. Plasma concentrations of RSP and 9-OH-RSP were determined using LC-MS/MS. The test and reference formulations were to be considered bioequivalent if the 90% CIs for the geometric mean test/reference ratios were within a predetermined range of 80% to 125%, in accordance with the policies of the Brazilian Sanitary Surveillance Agency and the US Food and Drug Administration. Tolerability was determined using clinical assessments, monitoring of vital signs, analysis of laboratory test results, and subject interviews regarding adverse events. Results: A total of 22 subjects were enrolled (11 men, 11 women; mean SD age, 32 12 years range, 18– 58 years; weight, 70.4 11.9 kg range, 50–103 kg; height, 1.67 0.08 m range, 1.56–1.80 m; and body mass index, 25 4 kg/m 2 range, 18–29 kg/m 2 ). For RSP, mean (SD) C max values were 12.6 (2.7) and 16.0 (2.3) ng/mL for the test and reference formulations, respectively. For 9-OH-RSP, mean C max values were 17.8 (1.3) and 21.0 (1.7) ng/mL for the test and reference formulations. The 90% CIs for the mean test/ reference ratios for RSP C max , AUC 0–120 , and AUC 0–∞ were 74% to 82%, 75% to 85%, and 76% to 85%, respectively, and 83% to 87%, 75% to 79%, and 75% to 78% for 9-OH-RSP. The related adverse events (headache, low back pain, drowsiness, standing hypotension, local postvenipuncture ecchymoses, insomnia, nausea, and vomiting) were transient and mild. Conclusions: This single-dose study found that the test and reference formulations of oral RSP 2 mg did not meet the Brazilian and US regulatory criteria for bioequivalence in these fasting, healthy volunteers. The study formulations appeared to be well tolerated. (Clin Ther. 2010;32:2106–2115) © 2010 Elsevier HS Journals