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Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial

BACKGROUND: The Exercise and Nutrition for Healthy AgeiNg (ENHANce) project aims to assess the combined effects of exercise and nutritional interventions to prevent loss of skeletal muscle mass and function with ageing, and to determine the underlying mechanisms of action. METHODS: One hundred eight...

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Autores principales: Dedeyne, Lenore, Dupont, Jolan, Koppo, Katrien, Verschueren, Sabine, Tournoy, Jos, Gielen, Evelien
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727134/
https://www.ncbi.nlm.nih.gov/pubmed/33302879
http://dx.doi.org/10.1186/s12877-020-01900-5
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author Dedeyne, Lenore
Dupont, Jolan
Koppo, Katrien
Verschueren, Sabine
Tournoy, Jos
Gielen, Evelien
author_facet Dedeyne, Lenore
Dupont, Jolan
Koppo, Katrien
Verschueren, Sabine
Tournoy, Jos
Gielen, Evelien
author_sort Dedeyne, Lenore
collection PubMed
description BACKGROUND: The Exercise and Nutrition for Healthy AgeiNg (ENHANce) project aims to assess the combined effects of exercise and nutritional interventions to prevent loss of skeletal muscle mass and function with ageing, and to determine the underlying mechanisms of action. METHODS: One hundred eightycommunity-dwelling sarcopenic individuals (≥ 65 years) are allocated in a randomized controlled trial (RCT) in a 1:1 ratio into five groups for a 12-week intervention period, followed by a 12-week follow-up period: 1) exercise intervention +protein placebo +omega-3 fatty acids placebo; 2) protein +omega-3 fatty acids placebo; 3) exercise intervention +protein +omega-3 fatty acids placebo; 4) exercise intervention +protein +omega-3 fatty acids; 5) protein placebo +omega-3 fatty acids placebo. All interventions are in line with recommendations of expert groups such as the American College of Sports Medicine and the PROT-AGE study group and individualized to the physical capabilities and nutritional intake of each participant. Sarcopenia is diagnosed by the assessment of gait speed, handgrip strength (Jamar handheld dynamometer), chair stand test and muscle mass (DXA) according to the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Participants, researchers and statisticians are blinded to omega-3 fatty acids and protein treatment. Compliance to the exercise program, protein and omega-3 fatty acids interventions is objectively measured, by monitoring movement by an activity monitor, determining nitrogen content in urine and analyzing the fatty acid composition of the red blood cell membrane. The primary outcome of the RCT is the change in Short Physical Performance Battery (SPPB) score. Secondary endpoints are, among others, changes in muscle mass, strength and function, objective compliance to interventions, changes in muscle and blood biomarkers related to sarcopenia, cognition, quality of life and falls. DISCUSSION: This RCT in well-defined sarcopenic older adults assesses the effects of combined anabolic interventions, including the additive effects of omega-3 fatty acids supplements, compared to single or placebo interventions. Compliance with the exercise intervention and with the intake of nutritional supplements is measured objectively. Also, blood and muscle samples will be used to explore the underlying determinants that contribute to the mechanism of action of anabolic interventions. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03649698, retrospectively registered at 28 August 2018, first participant was randomized 16 February 2018.
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spelling pubmed-77271342020-12-10 Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial Dedeyne, Lenore Dupont, Jolan Koppo, Katrien Verschueren, Sabine Tournoy, Jos Gielen, Evelien BMC Geriatr Study Protocol BACKGROUND: The Exercise and Nutrition for Healthy AgeiNg (ENHANce) project aims to assess the combined effects of exercise and nutritional interventions to prevent loss of skeletal muscle mass and function with ageing, and to determine the underlying mechanisms of action. METHODS: One hundred eightycommunity-dwelling sarcopenic individuals (≥ 65 years) are allocated in a randomized controlled trial (RCT) in a 1:1 ratio into five groups for a 12-week intervention period, followed by a 12-week follow-up period: 1) exercise intervention +protein placebo +omega-3 fatty acids placebo; 2) protein +omega-3 fatty acids placebo; 3) exercise intervention +protein +omega-3 fatty acids placebo; 4) exercise intervention +protein +omega-3 fatty acids; 5) protein placebo +omega-3 fatty acids placebo. All interventions are in line with recommendations of expert groups such as the American College of Sports Medicine and the PROT-AGE study group and individualized to the physical capabilities and nutritional intake of each participant. Sarcopenia is diagnosed by the assessment of gait speed, handgrip strength (Jamar handheld dynamometer), chair stand test and muscle mass (DXA) according to the European Working Group on Sarcopenia in Older People (EWGSOP2) criteria. Participants, researchers and statisticians are blinded to omega-3 fatty acids and protein treatment. Compliance to the exercise program, protein and omega-3 fatty acids interventions is objectively measured, by monitoring movement by an activity monitor, determining nitrogen content in urine and analyzing the fatty acid composition of the red blood cell membrane. The primary outcome of the RCT is the change in Short Physical Performance Battery (SPPB) score. Secondary endpoints are, among others, changes in muscle mass, strength and function, objective compliance to interventions, changes in muscle and blood biomarkers related to sarcopenia, cognition, quality of life and falls. DISCUSSION: This RCT in well-defined sarcopenic older adults assesses the effects of combined anabolic interventions, including the additive effects of omega-3 fatty acids supplements, compared to single or placebo interventions. Compliance with the exercise intervention and with the intake of nutritional supplements is measured objectively. Also, blood and muscle samples will be used to explore the underlying determinants that contribute to the mechanism of action of anabolic interventions. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03649698, retrospectively registered at 28 August 2018, first participant was randomized 16 February 2018. BioMed Central 2020-12-10 /pmc/articles/PMC7727134/ /pubmed/33302879 http://dx.doi.org/10.1186/s12877-020-01900-5 Text en © The Author(s) 2020 Open AccessThis 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/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Dedeyne, Lenore
Dupont, Jolan
Koppo, Katrien
Verschueren, Sabine
Tournoy, Jos
Gielen, Evelien
Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title_full Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title_fullStr Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title_full_unstemmed Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title_short Exercise and Nutrition for Healthy AgeiNg (ENHANce) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
title_sort exercise and nutrition for healthy ageing (enhance) project – effects and mechanisms of action of combined anabolic interventions to improve physical functioning in sarcopenic older adults: study protocol of a triple blinded, randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7727134/
https://www.ncbi.nlm.nih.gov/pubmed/33302879
http://dx.doi.org/10.1186/s12877-020-01900-5
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