Skip to main content
Clinical Trials/NCT04023513
NCT04023513
Unknown
Not Applicable

Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial

University of Vienna1 site in 1 country137 target enrollmentJune 1, 2018
ConditionsAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University of Vienna
Enrollment
137
Locations
1
Primary Endpoint
Change from baseline in chair stand test (repetitions)
Last Updated
6 years ago

Overview

Brief Summary

The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of resistance training (2x/week for 8 weeks) with and without different goals of protein intake on muscle strength, function and mass, oxidative stress parameters and the immune system in community dwelling persons.

Participants (n = 137) will be community-dwelling older adults. After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 groups (low protein + strength training, high protein + strength training, low protein and no strength training(=control)). Study participants are eligible if they are male or female with an age between 65 and 85 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the training sessions, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, a frailty index at or above 3, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.

Primary outcome measure is the change in the Chair Stand Test. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters, microbiota, metabolomics, proteomics and the nutritional status.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
January 1, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karl-Heinz Wagner

Professor of Human Nutrition

University of Vienna

Eligibility Criteria

Inclusion Criteria

  • Males and females between the age of 65 and 85 years of age
  • Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
  • Independently mobile

Exclusion Criteria

  • Chronic diseases, which contraindicate a training participation
  • Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
  • Diabetic retinopathy
  • Manifest osteoporosis
  • Regular use of cortisone-containing drugs
  • Regular strength training (\> 1x / week) in the last 6 months before inclusion

Outcomes

Primary Outcomes

Change from baseline in chair stand test (repetitions)

Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)

The maximum number of completed cycles of unsupported chair rises (from a seated to a fully erected position (hip and knees straightened)) completed within 30 s is counted.

Secondary Outcomes

  • Change from baseline in isometric quadriceps peak torque (Nm/kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in handgrip strength (kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in muscle mass with BIA (kg)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in stool short-chain fatty acids (SCFAs)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in 6min walking test (distance in meter)(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in the composition of gut-microbiota(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in oxidative stress marker such as malondialdehyd(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in the metabolomics response(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))
  • Change from baseline in the amino acid pattern(baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks))

Study Sites (1)

Loading locations...

Similar Trials