Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial
Introduction Short-term metabolic and observational studies suggest that protein intake above the recommended dietary allowance of 0.83 g/kg body weight (BW)/day may support preservation of lean body mass and physical function in old age, but evidence from randomised controlled trials is inconclusiv...
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BMJ Publishing Group
2020-11-01
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| author | Ingeborg A Brouwer Marjolein Visser Ilse Reinders Hanneke A H Wijnhoven Satu K Jyväkorpi Merja H Suominen Riikka Niskanen Kristien S Fluitman Michel C A Klein Lothar D Kuijper Laura M van der Lubbe Margreet R Olthof Kaisu H Pitkälä Rachel Vijlbrief |
| author_facet | Ingeborg A Brouwer Marjolein Visser Ilse Reinders Hanneke A H Wijnhoven Satu K Jyväkorpi Merja H Suominen Riikka Niskanen Kristien S Fluitman Michel C A Klein Lothar D Kuijper Laura M van der Lubbe Margreet R Olthof Kaisu H Pitkälä Rachel Vijlbrief |
| author_sort | Ingeborg A Brouwer |
| collection | DOAJ |
| description | Introduction Short-term metabolic and observational studies suggest that protein intake above the recommended dietary allowance of 0.83 g/kg body weight (BW)/day may support preservation of lean body mass and physical function in old age, but evidence from randomised controlled trials is inconclusive.Methods and analysis The PRevention Of Malnutrition In Senior Subjects in the EU (PROMISS) trial examines the effect of personalised dietary advice aiming at increasing protein intake with or without advice regarding timing of protein intake to close proximity of usual physical activity, on change in physical functioning after 6 months among community-dwelling older adults (≥65 years) with a habitual protein intake of <1.0 g/kg adjusted (a)BW/day. Participants (n=264) will be recruited in Finland and the Netherlands, and will be randomised into three groups; two intervention groups and one control group. Intervention group 1 (n=88) receives personalised dietary advice and protein-enriched food products in order to increase their protein intake to at least 1.2 g/kg aBW/day. Intervention group 2 (n=88) receives the same advice as described for intervention group 1, and in addition advice to consume 7.5–10 g protein through protein-(en)rich(ed) foods within half an hour after performing usual physical activity. The control group (n=88) receives no intervention. All participants will be invited to attend lectures not related to health. The primary outcome is a 6-month change in physical functioning measured by change in walk time using a 400 m walk test. Secondary outcomes are: 6-month change in the Short Physical Performance Battery score, muscle strength, body composition, self-reported mobility limitations, quality of life, incidence of frailty, incidence of sarcopenia risk and incidence of malnutrition. We also investigate cost-effectiveness by change in healthcare costs.Discussion The PROMISS trial will provide evidence whether increasing protein intake, and additionally optimising the timing of protein intake, has a positive effect on the course of physical functioning after 6 months among community-dwelling older adults with a habitual protein intake of <1.0 g/kg aBW/day.Ethics and dissemination The study has been approved by the Ethics Committee of the Helsinki University Central Hospital, Finland (ID of the approval: HUS/1530/2018) and The Medical Ethical Committee of the Amsterdam UMC, location VUmc, Amsterdam, the Netherlands (ID of the approval: 2018.399). All participants provided written informed consent prior to being enrolled onto the study. Results will be submitted for publication in peer-reviewed journals and will be made available to stakeholders (ie, older adults, healthcare professionals and industry).Trial registration number ClinicalTrials.gov Registry (NCT03712306). |
| format | Article |
| id | doaj-art-d211275ffb0c4612a5a076db799716d2 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-d211275ffb0c4612a5a076db799716d22025-08-20T02:49:46ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-040637Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trialIngeborg A Brouwer0Marjolein Visser1Ilse Reinders2Hanneke A H Wijnhoven3Satu K Jyväkorpi4Merja H Suominen5Riikka Niskanen6Kristien S Fluitman7Michel C A Klein8Lothar D Kuijper9Laura M van der Lubbe10Margreet R Olthof11Kaisu H Pitkälä12Rachel Vijlbrief13Department of Health Sciences and the EMGO Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, The NetherlandsDepartment of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Health Sciences, Faculty of Science, and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Health Sciences, Faculty of Science, and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of General Practice and Primary Health Care, University of Helsinki, Helsinki, FinlandDepartment of General Practice and Primary Health Care, University of Helsinki, Helsinki, FinlandDepartment of General Practice and Primary Health Care, University of Helsinki, Helsinki, FinlandDepartment of Internal Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health research institute, Amsterdam UMC, Amsterdam, The NetherlandsDepartment of Computer Science, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Health Sciences, Faculty of Science, and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Computer Science, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of Health Sciences, Faculty of Science, and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsDepartment of General Practice and Primary Health Care, University of Helsinki, Helsinki, FinlandDepartment of Health Sciences, Faculty of Science, and the Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsIntroduction Short-term metabolic and observational studies suggest that protein intake above the recommended dietary allowance of 0.83 g/kg body weight (BW)/day may support preservation of lean body mass and physical function in old age, but evidence from randomised controlled trials is inconclusive.Methods and analysis The PRevention Of Malnutrition In Senior Subjects in the EU (PROMISS) trial examines the effect of personalised dietary advice aiming at increasing protein intake with or without advice regarding timing of protein intake to close proximity of usual physical activity, on change in physical functioning after 6 months among community-dwelling older adults (≥65 years) with a habitual protein intake of <1.0 g/kg adjusted (a)BW/day. Participants (n=264) will be recruited in Finland and the Netherlands, and will be randomised into three groups; two intervention groups and one control group. Intervention group 1 (n=88) receives personalised dietary advice and protein-enriched food products in order to increase their protein intake to at least 1.2 g/kg aBW/day. Intervention group 2 (n=88) receives the same advice as described for intervention group 1, and in addition advice to consume 7.5–10 g protein through protein-(en)rich(ed) foods within half an hour after performing usual physical activity. The control group (n=88) receives no intervention. All participants will be invited to attend lectures not related to health. The primary outcome is a 6-month change in physical functioning measured by change in walk time using a 400 m walk test. Secondary outcomes are: 6-month change in the Short Physical Performance Battery score, muscle strength, body composition, self-reported mobility limitations, quality of life, incidence of frailty, incidence of sarcopenia risk and incidence of malnutrition. We also investigate cost-effectiveness by change in healthcare costs.Discussion The PROMISS trial will provide evidence whether increasing protein intake, and additionally optimising the timing of protein intake, has a positive effect on the course of physical functioning after 6 months among community-dwelling older adults with a habitual protein intake of <1.0 g/kg aBW/day.Ethics and dissemination The study has been approved by the Ethics Committee of the Helsinki University Central Hospital, Finland (ID of the approval: HUS/1530/2018) and The Medical Ethical Committee of the Amsterdam UMC, location VUmc, Amsterdam, the Netherlands (ID of the approval: 2018.399). All participants provided written informed consent prior to being enrolled onto the study. Results will be submitted for publication in peer-reviewed journals and will be made available to stakeholders (ie, older adults, healthcare professionals and industry).Trial registration number ClinicalTrials.gov Registry (NCT03712306).https://bmjopen.bmj.com/content/10/11/e040637.full |
| spellingShingle | Ingeborg A Brouwer Marjolein Visser Ilse Reinders Hanneke A H Wijnhoven Satu K Jyväkorpi Merja H Suominen Riikka Niskanen Kristien S Fluitman Michel C A Klein Lothar D Kuijper Laura M van der Lubbe Margreet R Olthof Kaisu H Pitkälä Rachel Vijlbrief Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial BMJ Open |
| title | Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial |
| title_full | Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial |
| title_fullStr | Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial |
| title_full_unstemmed | Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial |
| title_short | Effectiveness and cost-effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community-dwelling older adults with lower habitual protein intake: rationale and design of the PROMISS randomised controlled trial |
| title_sort | effectiveness and cost effectiveness of personalised dietary advice aiming at increasing protein intake on physical functioning in community dwelling older adults with lower habitual protein intake rationale and design of the promiss randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/11/e040637.full |
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