A forced titration study of the antioxidant and immunomodulatory effects of Ambrotose AO supplement

Background Oxidative stress plays a role in acute and chronic inflammatory disease and antioxidant supplementation has demonstrated beneficial effects in the treatment of these conditions. This study was designed to determine the optimal dose of an antioxidant supplement in healthy volunteers to inform a Phase 3 clinical trial. Methods The study was designed as a combined Phase 1 and 2 open label, forced titration dose response study in healthy volunteers (n = 21) to determine both acute safety and efficacy. Participants received a dietary supplement in a forced titration over five weeks commencing with a no treatment baseline through 1, 2, 4 and 8 capsules. The primary outcome measurement was ex vivo changes in serum oxygen radical absorbance capacity (ORAC). The secondary outcome measures were undertaken as an exploratory investigation of immune function. Results A significant increase in antioxidant activity (serum ORAC) was observed between baseline (no capsules) and the highest dose of 8 capsules per day (p = 0.040) representing a change of 36.6%. A quadratic function for dose levels was fitted in order to estimate a dose response curve for estimating the optimal dose. The quadratic component of the curve was significant (p = 0.047), with predicted serum ORAC scores increasing from the zero dose to a maximum at a predicted dose of 4.7 capsules per day and decreasing for higher doses. Among the secondary outcome measures, a significant dose effect was observed on phagocytosis of granulocytes, and a significant increase was also observed on Cox 2 expression. Conclusion This study suggests that Ambrotose AO® capsules appear to be safe and most effective at a dosage of 4 capsules/day. It is important that this study is not over interpreted; it aimed to find an optimal dose to assess the dietary supplement using a more rigorous clinical trial design. The study achieved this aim and demonstrated that the dietary supplement has the potential to increase antioxidant activity. The most significant limitation of this study was that it was open label Phase 1/Phase 2 trial and is subject to potential bias that is reduced with the use of randomization and blinding. To confirm the benefits of this dietary supplement these effects now need to be demonstrated in a Phase 3 randomised controlled trial (RCT).

Executive coaching : investigating effects of leader-empowering behaviours and psychological empowerment

Executive coaching is a rapidly expanding approach to leadership development which has grown at a rate that warrants extensive examination of its effects (Wasylyshyn, 2003). This thesis has therefore examined both behavioural and psychological effects based on a nine month executive coaching intervention within a large not-for-profit organisation. The intervention was a part of a larger ongoing integrated organisational strategy to create an organisational coaching culture. In order to examine the effectiveness of the nine month executive coaching intervention two studies were conducted. A quantitative study used a pre and post questionnaire to examine leaders and their team members‘ responses before and after the coaching intervention. The research examined leader-empowering behaviours, psychological empowerment, job satisfaction and affective commitment. Significant results were demonstrated from leaders‘ self-reports on leader-empowering behaviours and their team members‘ self-reports revealed a significant flow on effect of psychological empowerment. The second part of the investigation involved a qualitative study which explored the developmental nature of psychological empowerment through executive coaching. The examination dissected psychological empowerment into its widely accepted four facets of meaning, impact, competency and self-determination and investigated, through semi-structured interviews, leaders‘ perspectives of the effect of executive coaching upon them (Spreitzer, 1992). It was discovered that a number of the common practices within executive coaching, including goal-setting, accountability and action-reflection, contributed to the production of outcomes that developed higher levels of psychological empowerment. Careful attention was also given to organisational context and its influence upon the outcomes.