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

NCT02717819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2018-08-21

No results posted yet for this study

Summary

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Protein

Daily intake of supplement

DIETARY_SUPPLEMENT

Placebo

Daily intake of supplement

OTHER

Resistance training

Resistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge)

DIETARY_SUPPLEMENT

Vitamin D

Aiming at a dose of 20 ug/day. 20 ug/day will be handed out to study participants who do not get vitamin D supplements from the hospital while admitted and to those who are not already taking vitamin D supplements themselfes e.g. as part of a combination tablet.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • The Danish Dairy Research Foundation, Denmark

    collaborator OTHER
  • Arla Foods

    collaborator INDUSTRY
  • Glostrup University Hospital, Copenhagen

    collaborator OTHER
  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER
  • Forskningsenheden

    lead OTHER

Principal Investigators

  • Arne Astrup, DMSc · Copenhagen University Hospital at Herlev

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-15
Primary Completion
2017-12-20
Completion
2018-06-20

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717819 on ClinicalTrials.gov