Dietary Protein and Resistance Exercise in Elderly

NCT ID: NCT04023513

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2021-01-01

Brief Summary

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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

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

High protein intake

Intervention Type OTHER

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.

Strength training

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Low protein intake

Intervention Type OTHER

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 training

Intervention Type OTHER

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.

Group Type OTHER

Control, no intervention

Intervention Type OTHER

No Intervention, control

Interventions

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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.

Intervention Type OTHER

Control, no intervention

No Intervention, control

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Karl-Heinz Wagner

Professor of Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vienna, Department of Nutritional Sciences

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 35990326 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35390727 (View on PubMed)

Other Identifiers

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FA219002

Identifier Type: -

Identifier Source: org_study_id

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