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Clinical Study Protocol ARTICLE Provisionally accepted The full-text will be published soon. Notify me

Front. Aging Neurosci. | doi: 10.3389/fnagi.2019.00103

CoQ10 and Cognition a review and study protocol for a 90-day randomized controlled trial investigating the cognitive effects of Ubiquinol in the healthy elderly

 Con Stough1*, Madeleine Nankivell1,  David A. Camfield1,  Naomi L. Perry1,  Andrew Pipingas1,  Helen Macpherson2,  Keith A. Wesnes1, Ruching Ou1, David Hare3, Judy dehaan4, geoffrey head4, Peter Langsjoen5, Alena Langsjoen5,  Brendan Tan1,  Matthew P. Pase1, Rebecca King1, Renee Rowswell1, Oliver Zwalf1,  Joseph A. Rathner1, Matthew Cooke1 and Franklin Rosenfeldt1*
  • 1Swinburne University of Technology, Australia
  • 2Faculty of Health, Deakin Univeristy, Australia
  • 3Austin Health, University of Melbourne, Australia
  • 4Baker Heart and Diabetes Institute, Australia
  • 5East Texas Medical Center, United States

Introduction: With an ageing population there is an important need for the development of effective treatments for the amelioration of cognitive decline. Multiple mechanisms underlie age-related cognitive decline including cerebrovascular disease, oxidative stress, reduced antioxidant capacity and mitochondrial dysfunction. CoQ10 is a novel treatment which has the potential to improve brain function in healthy elderly populations due to established beneficial effects on mitochondrial function, vascular function and oxidative stress. Methods and Analysis: We describe the protocol for a 90-day randomized controlled trial which examines the efficacy of Ubiquinol (200mg/day) versus placebo for the amelioration of cognitive decline in a healthy (non-demented) elderly sample, aged 60 years and over. The primary outcome is the effect of Ubiquinol at 90-days compared to baseline on CogTrack composite measures of cognition. Additional cognitive measures, as well as measures of cardiovascular function, oxidative stress, liver function and mood will also be monitored across 30-, 60- and 90- day time points. Data analyses will involve repeated measures analysis of variance. Discussion: This study will be the first of its kind to provide important clinical and mechanistic data regarding the efficacy of Ubiquinol as a treatment for age-related cognitive decline in the healthy elderly with important implications for productivity and quality of life within this age group. Ethics and Dissemination: The study has been approved by the institutional ethics committee and all participants will provide written informed consent. Additionally, the trial has been registered with the Australian and New Zealand Clinical Trials Registry (ANZCTRN12618001841268).

Keywords: Cognition, Co-Q10, Ubiquinol, Aging, rct

Received: 17 Dec 2018; Accepted: 17 Apr 2019.

Edited by:

Patrizia Mecocci, University of Perugia, Italy

Reviewed by:

Grzegorz Bartosz, University of Łódź, Poland
Sanae Fukuda, Kansai University of Welfare Sciences, Japan  

Copyright: © 2019 Stough, Nankivell, Camfield, Perry, Pipingas, Macpherson, Wesnes, Ou, Hare, dehaan, head, Langsjoen, Langsjoen, Tan, Pase, King, Rowswell, Zwalf, Rathner, Cooke and Rosenfeldt. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Prof. Con Stough, Swinburne University of Technology, Hawthorn, Australia, cstough@swin.edu.au
Prof. Franklin Rosenfeldt, Swinburne University of Technology, Hawthorn, Australia, frosenfeldt@swin.edu.au