AgingNUTRIAGINGPROTNCT04023513
Dietary Protein and Resistance Exercise in Elderly
A study testing High protein intake, Low protein intake and Strength training in people with Aging, run by University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- High protein intake, Low protein intake and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
University of Vienna, Department of Nutritional Sciences
Vienna, 1090
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- High protein intake, Control, no intervention, Low protein intake, Strength training
- Keywords
- aging, protein intake, reistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein intakeOther
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.
Control, no interventionOther
No Intervention, control
Low protein intakeOther
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
Strength trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Strength Training and Protein high | Experimental | 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. Receives: Other: High protein intake; Other: Strength training |
| Strength Training and Protein low | Experimental | 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. Receives: Other: Low protein intake; Other: Strength training |
| Control | Other | No Intervention. Receives: Other: Control, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in chair stand test (repetitions)
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.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Secondary outcomes (10)
Change from baseline in isometric quadriceps peak torque (Nm/kg)
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.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in handgrip strength (kg)
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.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in muscle mass with BIA (kg)
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in 6min walking test (distance in meter)
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in the composition of gut-microbiota
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.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in stool short-chain fatty acids (SCFAs)
The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in oxidative stress marker such as malondialdehyd
The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde from baseline to the end of the intervention.
Measured: 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)
The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in the metabolomics response
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.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in the amino acid pattern
The plasma amino acid pattern will be assessed with HPLC-MS.
Measured: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Jun 2018
- Primary completion28 Feb 2019
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl-Heinz Wagner, University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023513
- Sponsor's protocol ID
- FA219002
- Acronym
- NUTRIAGINGPROT
- Status last verified
- Jul 2019
- First submitted
- 15 Jun 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spahits H, Unterberger S, Aschauer R, Zohrer PA, Draxler A, Franzke B, Strasser EM, Wessner B, Wagner KH, Tahir A. Impact of a high-protein diet with and without strength training over 17 weeks on the plasma metabolome in older adults. Age Ageing. 2026 Feb 1;55(2):afag010. doi: 10.1093/ageing/afag010.
PubMed 41638233Franzke 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.
PubMed 35990326Unterberger 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.
PubMed 35390727
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04023513
- Acronym / sponsor ID
- NUTRIAGINGPROT / FA219002
- Conditions
- Aging
- Keywords
- aging, protein intake, reistance training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strength Training and Protein high | Experimental | Other: High protein intake, Other: Strength training6 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. |
| Strength Training and Protein low | Experimental | Other: Low protein intake, Other: Strength training6 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. |
| Control | Other | Other: Control, no interventionNo Intervention. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein intake6 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 and Protein high |
| Control, no interventionNo Intervention, control | Other | Control |
| Low protein intake6 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 and Protein low |
| Strength training6 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 | Strength Training and Protein high, Strength Training and Protein low |
Primary outcome
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.
10 secondary outcomes
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)
Change from baseline in handgrip strength (kg)
Time frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
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)
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)
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)
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)
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)
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)
Change from baseline in the metabolomics response
Time frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Change from baseline in the amino acid pattern
Time frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 41638233Spahits H, Unterberger S, Aschauer R, Zohrer PA, Draxler A, Franzke B, Strasser EM, Wessner B, Wagner KH, Tahir A. Impact of a high-protein diet with and without strength training over 17 weeks on the plasma metabolome in older adults. Age Ageing. 2026 Feb 1;55(2):afag010. doi: 10.1093/ageing/afag010.
- Derived from this study: PubMed 35990326Franzke 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.
- Derived from this study: PubMed 35390727Unterberger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High protein intake, Low protein intake and Strength training in people with Aging, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in chair stand test (repetitions) (time frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04023513, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.