Dietary Protein and Resistance Exercise in Elderly

NCT04023513 | Unknown

• 1 other identifier: FA219002
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

aging; protein intake; reistance training

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

Study Arms (3)

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.

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.

Other: Low protein intake; Other: Strength training

Control

OTHER

No Intervention.

Other: Control, no intervention

Interventions

High protein intake 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 and Protein high

Control, no intervention OTHER

No Intervention, control

Control

Low protein intake 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 and Protein low

Strength training 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 high; Strength Training and Protein low

Eligibility Criteria

• Age: 65 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vienna: lead

Study Sites (1)

University of Vienna, Department of Nutritional Sciences

Vienna, 1090, Austria

Location

Related Publications (3)

• 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.

  PMID: 41638233 DERIVED

• 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.

  PMID: 35990326 DERIVED

• 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.

  PMID: 35390727 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: July 17, 2019
• Study Start: June 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: January 1, 2021
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

AU (1)