How feasible is nutrition intervention research in eating disorders? Lessons learnt from a pilot parallel randomised controlled trial of tyrosine supplementation in adolescents with anorexia nervosa
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Sibbritt, David
Wilcken, Bridget
Williams, Lauren T
Levick, Wayne
Nunn, Kenneth P
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Abstract
Objective Eating disorders are complex illnesses with high morbidity and mortality. Yet, there is promising evidence to support the effects of nutrition on the brain and behaviour. One proposed example is the use of tyrosine as an adjunct treatment in anorexia nervosa (AN). However, recruitment and retention in eating disorder clinical trials has posed difficulties for researchers. The aim of this study was to pilot test a parallel randomised controlled trial (RCT) of tyrosine supplementation to explore the feasibility of recruitment and retention, intervention adherence and data collection methods from the perspective of participants and researchers.
Method Feasibility was assessed using numbers participating, questionnaire completion in patients and parent/carers completing and declining participation, a researcher implementation record and clinical measures. Subjects included adolescents aged 12–17 years with AN. The study was conducted over a 12-week period, with the intervention group receiving 5 mg of L-tyrosine supplement and the control group receiving a placebo.
Results Recruitment targets were not met and recruitment to a full RCT based on the current study protocol and recruitment sites did not prove feasible. Of the 39 approached for RCT participation, seven were recruited to the RCT (18% response rate) despite extending recruitment periods, with 100% retained and analysed. Patients or parents/carers identified barriers to study participation including burden, the need to consume tyrosine as tablets, and the use of blood, urine and psychological testing. Blood tyrosine rose markedly for subjects in the intervention group. No side effects were reported or measured.
Conclusions This study offers a unique exploration of the feasibility of a tyrosine trial in anorexia nervosa and is of relevance to assist the success of future nutrition trials. Exploring the suitability of future study designs for nutrition intervention research is warranted.
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Journal of Eating Disorders
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12
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© Crown 2024. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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Hart, M; Sibbritt, D; Wilcken, B; Williams, LT; Levick, W; Nunn, KP, How feasible is nutrition intervention research in eating disorders? Lessons learnt from a pilot parallel randomised controlled trial of tyrosine supplementation in adolescents with anorexia nervosa, Journal of Eating Disorders, 2024, 12, pp. 181