Issues to consider in clinical trials of nutraceutical supplements: public perceptions and the reliability of magnetic resonance-based metrics

Abstract

Magnetic resonance (MR) measures have been used extensively within research, and while general reliability of measures has been assessed, the reliability of specific measurement techniques in specific populations is not always available. When used in clinical, or intervention-based trials, it is even more important to understand the reliability and reproducibility of these measures; allowing for assurance that changes seen in clinical trials are a result of the intervention, and not a result of systematic effects, systemic effects, or unreliable methods. Clinical trials, how they work, and what the data may or may not tell us, have also become more of a public concern since the Coronavirus disease-2019AD (COVID-19) pandemic; however, there is scant literature setting out the public’s perceptions or understanding of clinical trials. By first assessing a baseline for the beliefs and perceptions to clinical trials, as well as supplementation, researchers can begin to address areas that cause a lack of trust and understanding, potentially limiting participation in clinical studies. Furthermore, taking the pandemic into consideration during investigation may provide insight into the effect it had on these perceptions and beliefs.
The contents of this thesis encapsulate three experiments that cover a range of MR and clinical topics. With the dual overall aim of the thesis being: 1) to investigate the reproducibility and reliability of MR measures to assess brain health in older adults; and 2) to gather insightful information on public perceptions of clinical trials and nutraceutical supplementation.
Within this thesis we present insight into a sample of the UK population’s beliefs and perceptions towards clinical trials and supplementation; as well as showing the COVID-19 pandemic had minimal effects on these perceptions, nor on supplementation usage. We also demonstrate that an edited MR Spectroscopy sequence is a reproducible and reliable measure on older adults being tested over a medium time frame in a non-intervention clinical trial setting. As did we show the reproducibility of a breath-hold challenge for eliciting Cerebrovascular Reactivity (CVR) in older adults; measured via Arterial Spin Labelling (ASL) across the same medium timeframe. Additionally, CVR-ASL comparisons between older and younger adults also showed significant differences between the two groups.
The thesis adds to the understanding and reliability of MR measures used during clinical research to test neurophysiological changes, as well as lays the groundwork for understanding the public beliefs with regards to clinical trials and supplementation, and their supplementation usage. Both helping to ground future clinical research in both understanding and efficient measures.

Date of Award	27 May 2025
Original language	English
Awarding Institution	Bangor University
Sponsors	Kess II East & Agroceutical Products Limited
Supervisor	Paul Mullins (Supervisor), Giovanni D Avossa (Supervisor) & Radek Braganca (Supervisor)