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Protein Supplement and Exercise Training for the Treatment of Malnutrition and Sarcopenia Risk in Older Adults

Protein Supplement and Exercise Training for the Treatment of Malnutrition and Sarcopenia Risk in Older Adults

Recruiting
70 years and older
All
Phase N/A

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Overview

To explore the efficacy of a 12-week resistance exercise programme plus or minus an oral nutritional supplement on the nutritional status of community-dwelling older adults who receive homecare and are at risk of both malnutrition and sarcopenia.

Description

The aim of this study is to investigate the efficacy of consuming a whey protein oral nutritional supplement (ONS) enriched with leucine and vitamin D, in conjunction with a resistance-based exercise programme delivered using telehealth, versus the efficacy of the exercise programme alone, for twelve weeks, in a cohort of older adults who are at risk of both malnutrition and sarcopenia and who require supportive homecare.

The primary outcome will be nutritional status measured using the full form of the mini-nutritional assessment (MNA-FF). The secondary outcomes include feasibility of implementation, defined by recruitment, retention and adherence rates, measures of body composition, muscle strength and function as well as quality of life.

The exercise programme will be comprised of two sessions per week for 12-weeks and will be delivered using the UCD Zoom platform. The exercise programme will include strength movements that are intended to build muscle mass and improve physical function. The exercise programme will involve four phases split over the 12-week intervention: phase 1 (2 weeks), phase 2 (3 weeks), phase 3 (3 weeks) and phase 4 (4 weeks).

The groups will be as follows: (i) whey protein ONS enriched with leucine and vitamin D plus an exercise programme delivered using telehealth or (ii) exercise programme delivered using telehealth. Participants allocated to the ONS group will be provided with the ONS, and the exercise programme will be delivered using the UCD Zoom platform. To ensure that the PhD researcher can safely manage the study participants, there will be a staggered start. Two groups (a) ONS + exercise programme and (b) exercise programme alone will begin the intervention within one month of screening, complete the 12-week intervention and be reassessed after a further 12 weeks. The other two groups (c) ONS + exercise programme and (d) exercise programme alone will be assessed at week 0 and will begin the intervention 12 to 16 weeks later. Nutritional status will be reassessed to determine if any changes to nutritional status have occurred between screening and commencing the intervention. The staggered start group will then begin the intervention and complete the intervention after twelve weeks.

Eligibility

Inclusion Criteria:

  • Older adults (70+ years)
  • Requiring supportive homecare
  • At risk of malnutrition (MNA-SF)
  • At risk of sarcopenia (EWGSOP2)

Exclusion Criteria:

  • Cognitive impairment
  • Severe kidney disease (glomerular filtration rate < 30 mL/min)
  • Moderate to severe liver disease (Child-Pugh class B or C)
  • Psychiatric disorder
  • Receiving treatment or palliative care for cancer
  • Receiving enteral or parenteral nutrition
  • Hypersensitivity to any component of ONS
  • Taking ONS
  • Allergic to dairy products
  • Regularly undertaking resistance (strength) training
  • Advised by GP not to undertake physical activity

Study details
    Sarcopenia
    Malnutrition

NCT05688956

University College Dublin

27 January 2024

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