Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
Dietary Protein and Resistance Exercise in Elderly
Sponsors
Source
University of Vienna
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Active, not recruiting
Start Date
2018-06-01
Completion Date
2021-01-01
Primary Completion Date
2019-02-28
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change from baseline in chair stand test (repetitions) |
baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks) |
Secondary Outcome
Measure |
Time Frame |
|
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 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 stool short-chain fatty acids (SCFAs) |
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 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 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) |
Enrollment
137
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
Strength Training and Protein high
Intervention Type
Other
Intervention Name
Description
No Intervention, control
Arm Group Label
Control
Intervention Type
Other
Intervention Name
Description
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
Arm Group Label
Strength Training and Protein low
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
Gender
All
Gender Based
Yes
Minimum Age
65 Years
Maximum Age
85 Years
Healthy Volunteers
Accepts Healthy Volunteers
Location
Facility |
|
University of Vienna, Department of Nutritional Sciences Vienna 1090 Austria |
Location Countries
Country
Austria
Verification Date
2019-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Vienna
Investigator Full Name
Karl-Heinz Wagner
Investigator Title
Professor of Human Nutrition
Keywords
Has Expanded Access
No
Number Of Arms
3
Arm Group
Arm Group Label
Strength Training and Protein high
Arm Group Type
Experimental
Description
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.
Arm Group Label
Strength Training and Protein low
Arm Group Type
Experimental
Description
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.
Arm Group Label
Control
Arm Group Type
Other
Description
No Intervention.
Firstreceived Results Date
N/A
Acronym
NUTRIAGINGPROT
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)
Study First Submitted
June 15, 2019
Study First Submitted Qc
July 16, 2019
Study First Posted
July 17, 2019
Last Update Submitted
July 16, 2019
Last Update Submitted Qc
July 16, 2019
Last Update Posted
July 17, 2019
ClinicalTrials.gov processed this data on July 17, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.