4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Dietary Protein and Resistance Exercise in Elderly (NUTRIAGINGPROT)

Dietary Protein and Resistance Exercise in Elderly (NUTRIAGINGPROT)

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
Aging Other: High protein intake Other: Control, no intervention Other: Low protein intake Other: Strength training Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 1, 2018
Actual Primary Completion Date : February 28, 2019
Estimated Study Completion Date : January 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

Control
No Intervention.
Other: Control, no intervention
No Intervention, control

Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]
    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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks) ]
  5. 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) ]
    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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
Layout table for location information
Austria
University of Vienna, Department of Nutritional Sciences
Vienna, Austria, 1090
Sponsors and Collaborators
University of Vienna
Tracking Information
First Submitted Date  ICMJE June 15, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE June 1, 2018
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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) ]
    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.
  • Change from baseline in handgrip strength (kg) [ Time Frame: 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.
  • 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) ]
    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.
  • 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) ]
    The stool short-chain fatty acids (SCFAs) will be extracted and quantitatively analysed by gas chromatography.
  • 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) ]
    The investigators will consider changes in plasma concentrations of oxidative stress marker such as malondialdehyde from baseline to the end of the intervention.
  • 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) ]
    The investigators will consider changes in plasma concentrations of Interleukin 1 (IL-1), IL-6, IL-8, IL-10, TNF-alpha
  • Change from baseline in the metabolomics response [ Time Frame: 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.
  • Change from baseline in the amino acid pattern [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Protein and Resistance Exercise in Elderly
Official Title  ICMJE Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • 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: Control, no intervention
    No Intervention, control
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: High protein intake
    • Other: Strength training
  • 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.
    Interventions:
    • Other: Low protein intake
    • Other: Strength training
  • Control
    No Intervention.
    Intervention: Other: Control, no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2019)
137
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023513
Other Study ID Numbers  ICMJE FA219002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Karl-Heinz Wagner, University of Vienna
Study Sponsor  ICMJE University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Vienna
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP