TY - JOUR
T1 - Increase in colonic PRopionate as a method of prEVENTing weight gain in adults aged 20–40 years (iPREVENT)
T2 - protocol of a multi-centre, double-blind, randomised, parallel-group trial to investigate the efficacy of inulin-propionate ester versus inulin (control) in the prevention of weight gain over 12 months
AU - Pugh, Jennifer E.
AU - Anjum, Aisha
AU - Petropoulou, Katerina
AU - Thom, George
AU - Mccombie, Louise
AU - Tashkova, Martina
AU - Alaraj-Alshehhi, Sumayya
AU - Babalis, Daphne
AU - Prechtl, Christina
AU - Lean, Mike J.
AU - Prevost, A. Toby
AU - Vasconcelos, Joana C.
AU - Preston, Tom
AU - Morrison, Douglas
AU - Frost, Gary
N1 - Funding Information:
Infrastructure support for this research was provided by the NIHR Imperial Biomedical Research Centre (BRC) and the NIHR Imperial Clinical Research Facility.
Funding Information:
This work is funded by National Institute for Health Research (NIHR) under the Efficacy and Mechanism Evaluation Programme (EME) [15/185/16].
Publisher Copyright:
Copyright: © 2022 Pugh JE et al.
PY - 2022/10/10
Y1 - 2022/10/10
N2 - Introduction: Overweight and obesity affects over 70% of the UK population and is a major risk factor for the development of co-morbidities, including type 2 diabetes and cardiovascular disease. There now exists a considerable evidence base for the management of obesity. However, this is not the case for the prevention of obesity. Preventing weight gain in periods of life where there is an elevated risk of fat mass expansion could be beneficial to preventing associated diseases in later life. This protocol investigates the impact of novel food ingredient inulin propionate ester (IPE) in the prevention of weight gain. This trial aims to investigate the primary hypothesis that IPE has a superior effect on preventing body weight gain, compared with inulin, in young (<40 years old) adults over 12 months, whilst also investigating several complementary mechanisms that may explain the prevention of weight gain and improved long-term energy balance from consuming IPE. Methods: In this multi-centre, double-blind, randomised, parallel-group study, eligible participants will be randomly assigned to consume 10g IPE or 10g inulin (control) daily for 12 months. Study visits will be conducted at baseline, two-month, six-month and 12-month time points. The primary outcome is weight gain from baseline to 12 months. Secondary outcomes will examine changes in metabolic and cardiovascular health biomarkers, body composition and appetite. A mechanistic sub-group will explore causal mechanisms around energy balance, body composition, appetite regulation and the gut microbiota. Based on the power calculation, the sample size required is 270 participants or 135 per study group. Ethics and dissemination: The trial protocol and participant-facing documents have been reviewed and approved, by the London Hampstead Ethics Committee (REC Reference 19/LO/0095, 29 th January 2019). Upon completion, the trial results will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number: ISRCTN16299902, 1 st March 2018.
AB - Introduction: Overweight and obesity affects over 70% of the UK population and is a major risk factor for the development of co-morbidities, including type 2 diabetes and cardiovascular disease. There now exists a considerable evidence base for the management of obesity. However, this is not the case for the prevention of obesity. Preventing weight gain in periods of life where there is an elevated risk of fat mass expansion could be beneficial to preventing associated diseases in later life. This protocol investigates the impact of novel food ingredient inulin propionate ester (IPE) in the prevention of weight gain. This trial aims to investigate the primary hypothesis that IPE has a superior effect on preventing body weight gain, compared with inulin, in young (<40 years old) adults over 12 months, whilst also investigating several complementary mechanisms that may explain the prevention of weight gain and improved long-term energy balance from consuming IPE. Methods: In this multi-centre, double-blind, randomised, parallel-group study, eligible participants will be randomly assigned to consume 10g IPE or 10g inulin (control) daily for 12 months. Study visits will be conducted at baseline, two-month, six-month and 12-month time points. The primary outcome is weight gain from baseline to 12 months. Secondary outcomes will examine changes in metabolic and cardiovascular health biomarkers, body composition and appetite. A mechanistic sub-group will explore causal mechanisms around energy balance, body composition, appetite regulation and the gut microbiota. Based on the power calculation, the sample size required is 270 participants or 135 per study group. Ethics and dissemination: The trial protocol and participant-facing documents have been reviewed and approved, by the London Hampstead Ethics Committee (REC Reference 19/LO/0095, 29 th January 2019). Upon completion, the trial results will be published in peer-reviewed journals and presented at scientific conferences. Trial registration number: ISRCTN16299902, 1 st March 2018.
KW - gut microbiota
KW - obesity
KW - prevention
KW - propionate
KW - short-chain fatty acids
UR - http://www.scopus.com/inward/record.url?scp=85152908756&partnerID=8YFLogxK
U2 - 10.12688/f1000research.125950.1
DO - 10.12688/f1000research.125950.1
M3 - Article
AN - SCOPUS:85152908756
SN - 2046-1402
VL - 11
JO - F1000Research
JF - F1000Research
M1 - 1157
ER -
