Clinical trial NCT04023513: Dietary Protein and Resistance Exercise in Elderly
Official title: Effects of Low or High Amounts of Dietary Protein and Resistance Training on Community-dwelling Older Adults: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Keywords: aging
protein intake
reistance training
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 137
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in chair stand test (repetitions)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Secondary outcomes:
measure: Change from baseline in isometric quadriceps peak torque (Nm/kg)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in handgrip strength (kg)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in muscle mass with BIA (kg)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in 6min walking test (distance in meter)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in the composition of gut-microbiota
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in stool short-chain fatty acids (SCFAs)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in oxidative stress marker such as malondialdehyd
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in inflammatory marker (i.g. IL-6, TNF-alpha)
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in the metabolomics response
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
measure: Change from baseline in the amino acid pattern
timeFrame: baseline, after dietary intervention (6 weeks) and after dietary and strength training (14 weeks)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna, Department of Nutritional Sciences
Study officials:
References:
citation: 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.
citation: 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.