NUTRIAGINGPROT: Dietary Protein and Resistance Exercise in Elderly

Sponsor
University of Vienna (Other)
Overall Status
Unknown status
CT.gov ID
NCT04023513
Collaborator
(none)
137
1
3
31
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High protein intake
  • Other: Control, no intervention
  • Other: Low protein intake
  • Other: Strength training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
137 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Feb 28, 2019
Anticipated Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Strength Training and Protein high

6 weeks of high protein intake (additional 1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.

Other: High protein intake
6 weeks of high protein intake mainly via food (additional 1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.

Other: Strength training
6 weeks of different protein intake followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains

Experimental: Strength Training and Protein low

6 weeks of low protein intake (1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.

Other: Low protein intake
6 weeks of low protein intake (1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains

Other: Strength training
6 weeks of different protein intake followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains

Other: Control

No Intervention.

Other: Control, no intervention
No Intervention, control

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in chair stand test (repetitions) [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 Outcome Measures

  1. Change from baseline in isometric quadriceps peak torque (Nm/kg) [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    Isokinetic peak torque measurements of knee extensors and flexors will be performed using a LIDO Multijoint II isokinetic loading dynamometer. Participants will be tested in a sitting posion with their hip flexed at approximately 90° and subjects securely strapped to the seat of the chair using adjustable trunk and waist stabilisation belts. The anatomic axis of the knee rotation at the knee joint will aligned with the machine axis of rotation to insure similar movements for all participants. Two continuous maximal repetitions of knee extensors and knee flexors will be performed concentrically at each angular velocity (60°/s and 120°/s) for peak torque recording.

  2. Change from baseline in handgrip strength (kg) [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    Handgrip strength of the right hand will be measured to the nearest kilogram (kg) using a hand Dynamometer. Participants will be encouraged to perform a maximal contraction within approximately 4 to 5 s. After a rest of 60 s, participants will be asked to perform a second trial. The highest score of maximum voluntary contraction will be used for data analyses.

  3. Change from baseline in muscle mass with BIA (kg) [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

  4. Change from baseline in 6min walking test (distance in meter) [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

  5. Change from baseline in the composition of gut-microbiota [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    Gene sequencing of the 16S rRNA on the stool samples are performed to identify the microbes down to genus level, as well as the microbrobiota diversity and relative abundance.

  6. Change from baseline in stool short-chain fatty acids (SCFAs) [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.

  7. Change from baseline in oxidative stress marker such as malondialdehyd [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde from baseline to the end of the intervention.

  8. 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)]

    The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha

  9. Change from baseline in the metabolomics response [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    The metabolomic response (ie all metabolites) to the interventions will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.

  10. Change from baseline in the amino acid pattern [baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)]

    The plasma amino acid pattern will be assessed with HPLC-MS.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Vienna, Department of Nutritional Sciences Vienna Austria 1090

Sponsors and Collaborators

  • University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karl-Heinz Wagner, Professor of Human Nutrition, University of Vienna
ClinicalTrials.gov Identifier:
NCT04023513
Other Study ID Numbers:
  • FA219002
First Posted:
Jul 17, 2019
Last Update Posted:
Jul 22, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karl-Heinz Wagner, Professor of Human Nutrition, University of Vienna

Study Results

No Results Posted as of Jul 22, 2019