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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05502445
Other study ID # VFigueira
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date March 16, 2022

Study information

Verified date August 2022
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The food intake is often compromised in the elderly, and during hospitalization, dietary restrictions may be imposed, making them more susceptible to the risk of malnutrition and sarcopenia. It is essential to make an early identification of the elderly with low intake and involve them in their self-care. The aims will be assess the influence of the nutritionist's educational action to increase protein intake in elderly patients, to analyze the knowledge on its importance in the prevention of sarcopenia and to identify the prevalence of nutritional risk. This is a field, prospective, correlational, comparative and randomized study. The elderly patients will be randomized into a Control Group and Intervention Group.


Description:

The Control Group will follow the flow of nutritional assessment and monitoring while the Intervention Group will receive daily visits to monitor food intake, leaflet and educational video on the importance of protein and its source foods. In both groups, a questionnaire on knowledge of protein sources and its importance will be applied, and we will calculated the 24-hour recall of a regular day and for three days of hospitalization. Patients will be assessment by Mini Nutritional Assessment-Short Form and SARC-F and will be the measurements of calf circumference and hand grip strength.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - elderly patients aged 60 years or older, - with a prescription of oral feeding, exclusively, - minimum period of three days. Exclusion Criteria: - palliative care, - treatment for chronic renal failure, - patients with neurological deficit and dysphagia, - readmissions during the study, - receiving enteral and/or parenteral nutritional therapy, - patients in isolation.

Study Design


Intervention

Other:
educational intervention
In this group, the steps below are added:on the first day, the delivery of the leaflet on the importance of nutrition in the hospital environment will be added in addition to verbal guidance. On the second day, an educational institutional video with duration of two minutes, will be shown with the title "Food Intake and Oral Supplement in Nutritional Rehabilitation" via tablet or mobile phone. When the 24-hour recall will be collected, an assessment of food intake will be performed, mainly of foods that are sources of protein and, when they were less than 75%, strategies must be designed to increase the acceptance or indication of oral nutritional supplements.

Locations

Country Name City State
Brazil Hospital Israelita Albert Einstein São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (38)

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Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14. — View Citation

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Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13. — View Citation

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de van der Schueren MA, Wijnhoven HA, Kruizenga HM, Visser M. A critical appraisal of nutritional intervention studies in malnourished, community dwelling older persons. Clin Nutr. 2016 Oct;35(5):1008-14. doi: 10.1016/j.clnu.2015.12.013. Epub 2015 Dec 29. Review. — View Citation

Dijxhoorn DN, IJmker-Hemink VE, Wanten GJA, van den Berg MGA. Strategies to increase protein intake at mealtimes through a novel high-frequency food service in hospitalized patients. Eur J Clin Nutr. 2019 Jun;73(6):910-916. doi: 10.1038/s41430-018-0288-6. Epub 2018 Aug 22. — View Citation

Diz JB, Leopoldino AA, Moreira BS, Henschke N, Dias RC, Pereira LS, Oliveira VC. Prevalence of sarcopenia in older Brazilians: A systematic review and meta-analysis. Geriatr Gerontol Int. 2017 Jan;17(1):5-16. doi: 10.1111/ggi.12720. Epub 2016 Jan 22. Review. — View Citation

Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data from twelve British studies. PLoS One. 2014 Dec 4;9(12):e113637. doi: 10.1371/journal.pone.0113637. eCollection 2014. — View Citation

Dos Santos L, Cyrino ES, Antunes M, Santos DA, Sardinha LB. Sarcopenia and physical independence in older adults: the independent and synergic role of muscle mass and muscle function. J Cachexia Sarcopenia Muscle. 2017 Apr;8(2):245-250. doi: 10.1002/jcsm.12160. Epub 2016 Nov 8. — View Citation

Gray-Donald K, St-Arnaud-McKenzie D, Gaudreau P, Morais JA, Shatenstein B, Payette H. Protein intake protects against weight loss in healthy community-dwelling older adults. J Nutr. 2014 Mar;144(3):321-6. doi: 10.3945/jn.113.184705. Epub 2013 Dec 19. — View Citation

Hannan-Jones M, Capra S. Developing a valid meal assessment tool for hospital patients. Appetite. 2017 Jan 1;108:68-73. doi: 10.1016/j.appet.2016.09.025. Epub 2016 Sep 22. — View Citation

Hope K, Ferguson M, Reidlinger DP, Agarwal E. "I don't eat when I'm sick": Older people's food and mealtime experiences in hospital. Maturitas. 2017 Mar;97:6-13. doi: 10.1016/j.maturitas.2016.12.001. Epub 2016 Dec 12. — View Citation

Houston DK, Nicklas BJ, Ding J, Harris TB, Tylavsky FA, Newman AB, Lee JS, Sahyoun NR, Visser M, Kritchevsky SB; Health ABC Study. Dietary protein intake is associated with lean mass change in older, community-dwelling adults: the Health, Aging, and Body Composition (Health ABC) Study. Am J Clin Nutr. 2008 Jan;87(1):150-5. — View Citation

Ingadottir AR, Beck AM, Baldwin C, Weekes CE, Geirsdottir OG, Ramel A, Gislason T, Gunnarsdottir I. Association of energy and protein intakes with length of stay, readmission and mortality in hospitalised patients with chronic obstructive pulmonary disease. Br J Nutr. 2018 Mar;119(5):543-551. doi: 10.1017/S0007114517003919. — View Citation

Introduction: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S1-S2. doi: 10.2337/dc20-Sint. — View Citation

Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. — View Citation

Kaiser MJ, Bauer JM, Rämsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony PS, Charlton KE, Maggio M, Tsai AC, Vellas B, Sieber CC; Mini Nutritional Assessment International Group. Frequency of malnutrition in older adults: a multinational perspective using the mini nutritional assessment. J Am Geriatr Soc. 2010 Sep;58(9):1734-8. doi: 10.1111/j.1532-5415.2010.03016.x. — View Citation

Landi F, Picca A, Calvani R, Marzetti E. Anorexia of Aging: Assessment and Management. Clin Geriatr Med. 2017 Aug;33(3):315-323. doi: 10.1016/j.cger.2017.02.004. Epub 2017 May 20. Review. — View Citation

Malafarina V, Uriz-Otano F, Iniesta R, Gil-Guerrero L. Effectiveness of nutritional supplementation on muscle mass in treatment of sarcopenia in old age: a systematic review. J Am Med Dir Assoc. 2013 Jan;14(1):10-7. doi: 10.1016/j.jamda.2012.08.001. Epub 2012 Sep 13. Review. — View Citation

Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. — View Citation

Morley JE. Anorexia of ageing: a key component in the pathogenesis of both sarcopenia and cachexia. J Cachexia Sarcopenia Muscle. 2017 Aug;8(4):523-526. doi: 10.1002/jcsm.12192. Epub 2017 Apr 27. — View Citation

Morley JE. Nutrition in the elderly. Curr Opin Gastroenterol. 2002 Mar;18(2):240-5. — View Citation

Pilgrim AL, Robinson SM, Sayer AA, Roberts HC. An overview of appetite decline in older people. Nurs Older People. 2015 Jun;27(5):29-35. doi: 10.7748/nop.27.5.29.e697. — View Citation

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Roberts S, Desbrow B, Chaboyer W. Feasibility of a patient-centred nutrition intervention to improve oral intakes of patients at risk of pressure ulcer: a pilot randomised control trial. Scand J Caring Sci. 2016 Jun;30(2):271-80. doi: 10.1111/scs.12239. Epub 2015 Jun 2. — View Citation

Roberts S, Hopper Z, Chaboyer W, Gonzalez R, Banks M, Desbrow B, Marshall AP. Engaging hospitalised patients in their nutrition care using technology: development of the NUTRI-TEC intervention. BMC Health Serv Res. 2020 Feb 27;20(1):148. doi: 10.1186/s12913-020-5017-x. — View Citation

Sieske L, Janssen G, Babel N, Westhoff TH, Wirth R, Pourhassan M. Inflammation, Appetite and Food Intake in Older Hospitalized Patients. Nutrients. 2019 Aug 22;11(9). pii: E1986. doi: 10.3390/nu11091986. — View Citation

Ten Haaf DSM, van Dongen EJI, Nuijten MAH, Eijsvogels TMH, de Groot LCPGM, Hopman MTE. Protein Intake and Distribution in Relation to Physical Functioning and Quality of Life in Community-Dwelling Elderly People: Acknowledging the Role of Physical Activity. Nutrients. 2018 Apr 19;10(4). pii: E506. doi: 10.3390/nu10040506. — View Citation

Tieland M, Borgonjen-Van den Berg KJ, Van Loon LJ, de Groot LC. Dietary Protein Intake in Dutch Elderly People: A Focus on Protein Sources. Nutrients. 2015 Nov 25;7(12):9697-706. doi: 10.3390/nu7125496. — View Citation

Unger T, Borghi C, Charchar F, Khan NA, Poulter NR, Prabhakaran D, Ramirez A, Schlaich M, Stergiou GS, Tomaszewski M, Wainford RD, Williams B, Schutte AE. 2020 International Society of Hypertension Global Hypertension Practice Guidelines. Hypertension. 2020 Jun;75(6):1334-1357. doi: 10.1161/HYPERTENSIONAHA.120.15026. Epub 2020 May 6. — View Citation

Vasse E, Beelen J, de Roos NM, Janssen N, de Groot LC. Protein intake in hospitalized older people with and without increased risk of malnutrition. Eur J Clin Nutr. 2018 Jun;72(6):917-919. doi: 10.1038/s41430-018-0171-5. Epub 2018 May 15. — View Citation

Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Goisser S, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber CC, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN guideline on clinical nutrition and hydration in geriatrics. Clin Nutr. 2019 Feb;38(1):10-47. doi: 10.1016/j.clnu.2018.05.024. Epub 2018 Jun 18. — View Citation

Weijzen MEG, Kouw IWK, Geerlings P, Verdijk LB, van Loon LJC. During Hospitalization, Older Patients at Risk for Malnutrition Consume <0.65 Grams of Protein per Kilogram Body Weight per Day. Nutr Clin Pract. 2020 Aug;35(4):655-663. doi: 10.1002/ncp.10542. Epub 2020 Jun 24. — View Citation

* Note: There are 38 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Total energy and protein needs and intakes from dietary and oral nutritional supplements during hospitalization, according to the study group Energy and protein intakes per kg of actual body weight and per day three days
Secondary Assessment and screening of sarcopenia risk by SARC-F questionnaire Patients who present a result greater than or equal to 4 of this questionnaire are classified as risk of sarcopenia one day (first day of assessment)
Secondary Assessment of low muscle strength The values that discriminate the altered exam are different for each age and sex. The result will be expressed as normal or low muscle strength one day (first day of assessment)
Secondary Assessment of low muscle mass by measuring the calf circumference the cutoff points of 33cm for females and 34cm for males were used one day (first day of assessment)
Secondary Assessment and screening of nutritional risk Assessment by Mini Nutritional Assessment-Short Form, it has the three classifications: 0-7 points: malnourished; 8 -11 points: at risk of malnutrition; or 12-14 points: well-nourished one day (first day of assessment)
Secondary Dietary prescription of hospitalized elderly to evaluate the number of hospitalized elderly who remained with salt and sugar restriction in the diet, according to medical prescription three days
Secondary Questionnaire on previous knowledge of protein source foods and sarcopenia The questionnaire has 9 questions related to knowledge of protein source foods and their importance on health and impact when consumption is not adequate. The last question is about physical activity, to assess how many patients follow the World Health Organization's recommendation. Was evaluated how many patients answered the questions correctly and how many practiced physical activity one day
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