Effects of low-volume, high-intensity interval training on maximal oxygen consumption, body fat percentage and health-related quality of life in women with overweight: A randomized controlled trial.

BACKGROUND: Several investigations suggest that high-intensity interval training (HIIT) provokes larger changes in VO2max compared to moderate-intensity continuous training (MICT); other studies associate HIIT with significant decreases in total, abdominal and visceral fat mass. However, some meta-analyses express that the enhancements with HIIT on VO2max are slightly higher concerning MICT. These studies had low-to-moderate methodological quality, and the exercise protocols were completed mostly on treadmills or cycle ergometers. Thus, the objective of this study was to compare the effect of a low-volume HIIT versus a MICT program on VO2max, body fat percentage (BFP), and health-related quality of life (HRQoL) in overweight women. It followed a research protocol with high methodological rigor and good reporting quality. METHODS: After two physical adaptation weeks (run-in period), thirty-five volunteers were randomized to HIIT (n = 16) or MICT (n = 19). Both groups performed 24 sessions on a grass sports field (walking, jogging or running). The HIIT group completed 15 bouts of 30 s [90-95%, maximal heart rate (HRmax)], while the MICT group completed 30 min of continuous exercise (65-75% HRmax). RESULTS: The difference between HIIT and MICT post-intervention on VO2max was not statistically significant (0.8 ml/kg/min. CI 95%, -1.0 to 2.7, p = 0.37). Similarly, no statistically significant differences were found between groups for BFP and HRQoL. CONCLUSIONS: Low-volume HIIT program has no quantitative advantage compared with that resulting from MICT, in VO2max, BFP, and HRQoL. ClinicalTrials.gov Identifier: NCT03300895.

Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression: a randomized placebo-controlled trial.

BACKGROUND: Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression. METHODS: To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing. RESULTS: We observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p = 0.04), and at D7 (p < 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen's d = 0.84; D2: Cohen's d = 0.84; D7: Cohen's d = 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64% v. 27%; p = 0.04). Remission rate showed a trend toward significance at D7 (36% v. 7%, p = 0.054). CONCLUSIONS: To our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered at http://clinicaltrials.gov (NCT02914769).

The Lulun Project's social marketing strategy in a trial to introduce eggs during complementary feeding in Ecuador.

The Lulun Project incorporated a social marketing strategy that accompanied a randomized controlled trial (RCT) of a food-based intervention that introduced eggs into the complementary feeding diet of Ecuadorian infants. This strategy was designed to promote behaviour change, in this case, egg consumption, through voluntary prosocial behaviour, empowerment, and brand loyalty. A three-phase social marketing strategy (design, campaigns, and evaluation) contributed to our successful RTC by applying techniques drawn from marketing, publicity, design, and communications. To develop the strategy, we conducted (a) market research focused on culturally based norms, values, and local expectations; (b) a situational assessment based on the four Ps of social marketing (people, product, place, and price); and (c) fostered a creative process to develop the project's brand and communication plan. The strategy combined a communication plan, brand, and activities that were implemented in four campaigns: outreach, recruitment, promotion, and closing. Our evaluation showed that the social marketing strategy was instrumental in promoting the RCT's objectives and responding to unforeseen events and community concerns regarding the RCT. The strategy resulted in high compliance, low attrition, and infant feeding policy change, including Ecuador's Ministry of Public Health new complementary feeding guidelines for introducing eggs early in complementary feeding. Use of social marketing techniques, like those in our study, could be key for scaling up this food-based intervention-or others like it-in Ecuador and beyond.

The Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery: A Randomized, Placebo-Controlled Trial.

BACKGROUND: Cardiac surgery-related acute kidney injury (AKI) is a common postoperative complication that greatly increases morbidity and mortality. There are currently no effective interventions to prevent AKI associated with cardiac surgery. Experimental data have shown that administration of the mineralocorticoid receptor blocker spironolactone prevents renal injury induced by ischemia-reperfusion in rats. The objective of this study was to test whether short-term perioperative administration of oral spironolactone could reduce the incidence of AKI in cardiac surgical patients. STUDY DESIGN: Randomized, double-blinded, placebo-controlled trial. SETTING & PARTICIPANTS: Data were collected from April 2014 through July 2015 at the National Heart Institute in Mexico. 233 patients were included; 115 and 118 received spironolactone or placebo, respectively. INTERVENTION: Spironolactone or placebo once at a dose of 100mg 12 to 24 hours before surgery and subsequently 3 further doses of 25mg in postoperative days 0, 1, and 2 were administered. OUTCOMES: Patients were followed up for 7 days or until discharge from the intensive care unit (ICU). The primary end point was AKI incidence defined by KDIGO criteria. Secondary end points included requirement of renal replacement therapy, ICU length of stay, and ICU mortality. Data were analyzed according to the intention-to-treat principle. RESULTS: Mean age was 53.2±15 years, mean serum creatinine level was 0.9±0.2mg/dL, median Thakar score for estimation of AKI risk was 2 (IQR, 1-3), and 25% had diabetes. The incidence of AKI was higher for the spironolactone group (43% vs 29%; P=0.02). No significant differences were found for secondary end points. LIMITATIONS: Single center, AKI was mostly driven by AKI stage 1, planned sample size was not achieved, and there was no renin-angiotensin-aldosterone system washout period. CONCLUSIONS: Our trial demonstrated that spironolactone was not protective for AKI associated with cardiac surgery and there may be a trend toward risk.