Design of a randomised controlled trial: does indirect calorimetry energy information influence weight loss in obesity?

Jonathan Lim, Uazman Alam, Daniel Cuthbertson, John Wilding, Jonathan Lim, Uazman Alam, Daniel Cuthbertson, John Wilding

Abstract

Introduction: Respiratory quotient (RQ) provides an indication of the relative balance of carbohydrate and fat oxidation. RQ could serve as an early biomarker of negative energy balance during weight loss. Restriction of energy intake relative to total daily energy requirements produces a negative energy balance which can lead to a fall in RQ, accompanied by a decrease in resting energy expenditure (REE). However, the net change in body weight does not usually match predicted weight change due to intraindividual metabolic adaptations. Our aim is to determine the effectiveness of utilising EE information from indirect calorimetry during weight loss intervention.

Methods and analysis: We will undertake an assessor-blinded, parallel-group randomised controlled trial of 105 adults with obesity randomised in 1:1 ratio to receive either standard weight management care (SC) or EE information plus SC (INT) during a 24-week multicomponent weight management programme. The primary outcome is difference in weight loss between INT and SC group at 24 weeks. Secondary outcomes include: change in RQ, REE, glycaemic variability, and appetite-relating gut hormones (glucagon-like peptide 1, gastric inhibitory polypeptide, peptide YY). Generalised linear mixed models (intention to treat) will assess outcomes for treatment (INT vs SC), time (baseline, 24 weeks) and the treatment-by-time interaction. This will be the first study to evaluate impact of utilising measured REE and RQ on the lifestyle-based intensive intervention programme.

Ethics and dissemination: Ethics approval was obtained from the Health Research Authority and the North West Research Ethics Committee (18/NW/0645). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations.

Trial registration numbers: NCT03638895; UoL001379.

Keywords: diabetes & endocrinology; nutrition & dietetics; respiratory physiology.

Conflict of interest statement

Competing interests: JW reports personal fees, grants, and consultancy fees paid to his institution from AstraZeneca, Novo Nordisk, and Takeda, personal fees and consultancy fees paid to his institution from Boehringer Ingelheim, Janssen, Napp, Mundipharma, and Sanofi, and consultancy fees paid to his institution from Lilly, Rhythm Pharmaceuticals and Wilmington Healthcare outside of the submitted work. JL, UA and DC has no competing interests to declare.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

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