NCT02717819: PEPOP

The Importance of Additional Protein to Benefit More From Training During and After Hospitalization

Completed NA Last updated 21 August 2018

What this trial tests

NA trial testing Protein in Sarcopenia in 165 participants. Completed in 20 June 2018.

Timeline

15 April 2016

Primary endpoint
20 December 2017

20 June 2018

Quick facts

Lead sponsor	Forskningsenheden
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	165
Start date	15 April 2016
Primary completion	20 December 2017
Estimated completion	20 June 2018
Sites	3 locations across Denmark

Drugs / interventions tested

• Protein
• Placebo
• Resistance training
• Vitamin D

Conditions studied

• Sarcopenia — all drugs for Sarcopenia →

Sponsor

Forskningsenheden

Who can join

70 and older, any sex, with Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to investigate if an increased protein intake, in the form of a protein-enriched, milk-based supplement, can enhance the beneficial effect of resistance training, offered during hospitalization and 12 weeks post discharge, in older patients. This will in part be evaluated from measures of muscle strength, muscle mass and physical functioning. Also, the study population's acceptance of the intervention product will be assessed along with measures related to 'cost-effectiveness'.

A sub-study will be performed in a sub-group (n=30) to investigate if bio-impedance analysis (BIA) correlates with Dual-Energy X-ray absorptiometry (DXA) at single time points, and to see if it is possible to track changes in lean body mass. In addition, the reliability of the bio-impedance analyzer will be evaluated.

Also, the prevalence and classification of sarcopenia will be assessed at baseline, and correlations to nutritional status will be investigated (n=120).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of Pharmacotherapies for the Treatment of Sarcopenia.
   Rooks D, Roubenoff R. · · 2019 · cited 27× · PMID 31237312 · DOI 10.14283/jfa.2019.11
2. Protein-enriched, milk-based supplement to counteract sarcopenia in acutely ill geriatric patients offered resistance exercise training during and after hospitalisation: study protocol for a randomised, double-blind, multicentre trial.
   Gade J, Beck AM, Bitz C, Christensen B, et al · · 2018 · cited 13× · PMID 29391380 · DOI 10.1136/bmjopen-2017-019210