- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04023513
Dietary Protein and Resistance Exercise in Elderly (NUTRIAGINGPROT)
Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- University of Vienna, Department of Nutritional Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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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.
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.
|
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
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
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OTHER: Control
No Intervention.
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No Intervention, control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in chair stand test (repetitions)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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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.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in isometric quadriceps peak torque (Nm/kg)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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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.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in handgrip strength (kg)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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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.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in muscle mass with BIA (kg)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in 6min walking test (distance in meter)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in the composition of gut-microbiota
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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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.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in stool short-chain fatty acids (SCFAs)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in oxidative stress marker such as malondialdehyd
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde from baseline to the end of the intervention.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in the metabolomics response
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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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.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Change from baseline in the amino acid pattern
Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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The plasma amino acid pattern will be assessed with HPLC-MS.
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baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Franzke B, Bileck A, Unterberger S, Aschauer R, Zohrer PA, Draxler A, Strasser EM, Wessner B, Gerner C, Wagner KH. The plasma proteome is favorably modified by a high protein diet but not by additional resistance training in older adults: A 17-week randomized controlled trial. Front Nutr. 2022 Aug 5;9:925450. doi: 10.3389/fnut.2022.925450. eCollection 2022.
- Unterberger S, Aschauer R, Zohrer PA, Draxler A, Franzke B, Strasser EM, Wagner KH, Wessner B. Effects of an increased habitual dietary protein intake followed by resistance training on fitness, muscle quality and body composition of seniors: A randomised controlled trial. Clin Nutr. 2022 May;41(5):1034-1045. doi: 10.1016/j.clnu.2022.02.017. Epub 2022 Feb 24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FA219002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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