TY - JOUR
T1 - The PROMOTe study
T2 - targeting the gut microbiome with prebiotics to overcome age-related anabolic resistance: protocol for a double-blinded, randomised, placebo-controlled trial
AU - Ni Lochlainn, Mary
AU - Nessa, Ayrun
AU - Sheedy, Alyce
AU - Horsfall, Rachel
AU - García, María Paz
AU - Hart, Deborah
AU - Akdag, Gulsah
AU - Yarand, Darioush
AU - Wadge, Samuel
AU - Baleanu, Andrei-Florin
AU - Whelan, Kevin
AU - Steves, Claire
N1 - Funding Information:
MNL and the PROMOTe study are supported by a National Institute of Health Research (NIHR) Doctoral Fellowship (award reference: NIHR300159).
Funding Information:
CJS receives funds from the MRC, Wellcome Trust, and the Chronic Disease Research Foundation. KW receives funds from MRC, NIHR, Crohn’s & Colitis UK, Kenneth Rainin Foundation, Leona M and Harry B Helmsley Charitable Trust, Almond Board of California, Danone, International Dried Fruit Council.
Funding Information:
An abstract of this work was presented at the 15th International Congress of the European Geriatric Medicine Society 25?27 September 2019, Krakow. We would like to thank the clinical team at the department of twin research and genetic epidemiology, namely Johanna Honey, Maxine Smith, Shukri Noor, Alice Acutt and Aaruthy Suthahar. We would like to acknowledge Christel Barnetson for her help in planning the finances of the study. We would like to acknowledge the volunteers in the TwinsUK cohort, without whom, this research would not be possible.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - BACKGROUND: Loss of skeletal muscle mass and strength occurs with increasing age and is associated with loss of function, disability, and the development of sarcopenia and frailty. Dietary protein is essential for skeletal muscle function, but older adults do not anabolise muscle in response to protein supplementation as well as younger people, so called 'anabolic resistance'. The aetiology and molecular mechanisms for this are not understood, however the gut microbiome is known to play a key role in several of the proposed mechanisms. Thus, we hypothesise that the gut microbiome may mediate anabolic resistance and therefore represent an exciting new target for ameliorating muscle loss in older adults. This study aims to test whether modulation of the gut microbiome using a prebiotic, in addition to protein supplementation, can improve muscle strength (as measured by chair-rise time) versus protein supplementation alone.METHODS: The study is a randomised, double-blinded, placebo-controlled trial, with two parallel arms; one will receive prebiotic and protein supplementation, and the other will receive placebo (maltodextrin) and protein supplementation. Participants will be randomised as twin pairs, with one twin from each pair in each arm. Participants will be asked to take supplementation once daily for 12 weeks in addition to resistance exercises. Every participant will receive a postal box, containing their supplements, and the necessary equipment to return faecal, urine, saliva and capillary blood samples, via post. A virtual visit will be performed using online platform at the beginning and end of the study, with measures taken over video. Questionnaires, food diary and cognitive testing will be sent out via email at the beginning and end of the study.DISCUSSION: This study aims to provide evidence for the role of the gut microbiome in anabolic resistance to dietary protein. If those who take the prebiotic and protein supplementation have a greater improvement in muscle strength compared with those who take protein supplementation alone, this would suggest that strategies to modify the gut microbiome may reduce anabolic resistance, and therefore potentially mitigate sarcopenia and frailty in older adults.TRIAL REGISTRATION: Clinicaltrials.gov: NCT04309292 . Registered on the 2nd May 2020.
AB - BACKGROUND: Loss of skeletal muscle mass and strength occurs with increasing age and is associated with loss of function, disability, and the development of sarcopenia and frailty. Dietary protein is essential for skeletal muscle function, but older adults do not anabolise muscle in response to protein supplementation as well as younger people, so called 'anabolic resistance'. The aetiology and molecular mechanisms for this are not understood, however the gut microbiome is known to play a key role in several of the proposed mechanisms. Thus, we hypothesise that the gut microbiome may mediate anabolic resistance and therefore represent an exciting new target for ameliorating muscle loss in older adults. This study aims to test whether modulation of the gut microbiome using a prebiotic, in addition to protein supplementation, can improve muscle strength (as measured by chair-rise time) versus protein supplementation alone.METHODS: The study is a randomised, double-blinded, placebo-controlled trial, with two parallel arms; one will receive prebiotic and protein supplementation, and the other will receive placebo (maltodextrin) and protein supplementation. Participants will be randomised as twin pairs, with one twin from each pair in each arm. Participants will be asked to take supplementation once daily for 12 weeks in addition to resistance exercises. Every participant will receive a postal box, containing their supplements, and the necessary equipment to return faecal, urine, saliva and capillary blood samples, via post. A virtual visit will be performed using online platform at the beginning and end of the study, with measures taken over video. Questionnaires, food diary and cognitive testing will be sent out via email at the beginning and end of the study.DISCUSSION: This study aims to provide evidence for the role of the gut microbiome in anabolic resistance to dietary protein. If those who take the prebiotic and protein supplementation have a greater improvement in muscle strength compared with those who take protein supplementation alone, this would suggest that strategies to modify the gut microbiome may reduce anabolic resistance, and therefore potentially mitigate sarcopenia and frailty in older adults.TRIAL REGISTRATION: Clinicaltrials.gov: NCT04309292 . Registered on the 2nd May 2020.
UR - http://www.scopus.com/inward/record.url?scp=85109186195&partnerID=8YFLogxK
U2 - 10.1186/s12877-021-02301-y
DO - 10.1186/s12877-021-02301-y
M3 - Article
C2 - 34210274
SN - 1471-2318
VL - 21
SP - 407
JO - BMC Geriatrics
JF - BMC Geriatrics
IS - 1
M1 - 407
ER -