The Role of Muscle Protein Breakdown in the Regulation of Muscle Quality in Frail Elderly Individuals

NCT03326648 | Completed

• 1 other identifier: STAS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate mechanisms underlying the reduction in muscle quality (the ratio between muscle strength and muscle size) with aging, and to investigate how these factors are affected by strength training and protein supplementation. It is already established that muscle quality defined as the ratio between the strength and the size of a muscle is improved with strength training, even in frail elderly individuals. However, the relative contribution of factors such as activation level, fat infiltration, muscle architecture and single fiber function is unknown. The main focus of this study is to investigate the relationship between muscle quality and muscle protein breakdown, as insufficient degradation of proteins is hypothesized to negatively affect muscle quality.

Conditions

Sarcopenia

Keywords

Sarcopenia; Frailty; Strength training; Autophagy

Outcome Measures

Primary Outcomes (1)

• Single fiber specific force

  A measure of muscle quality at the single fiber level. Biopsies obtained from m. Vastus Lateralis

  Change from baseline at 10 weeks

Secondary Outcomes (51)

• Lean mass

  Change from baseline at 10 weeks

• Fat mass

  Change from baseline at 10 weeks

• Bone mineral density

  Change from baseline at 10 weeks

• Muscle strength of m. quadriceps

  Change from baseline at 10 weeks

• Muscle size of m. quadriceps

  Change from baseline at 10 weeks

Study Arms (2)

Strength training + protein supplement

EXPERIMENTAL

Two sessions of strength training each week in addition to daily protein supplementation for 10 weeks.

Other: Strength training; Dietary Supplement: Protein supplementation

Protein supplement

EXPERIMENTAL

Daily protein supplementation for 10 weeks.

Dietary Supplement: Protein supplementation

Interventions

Strength training OTHER

Heavy load strength training performed twice a week for 10 weeks.

Also known as: Resistance training

Strength training + protein supplement

Protein supplementation DIETARY_SUPPLEMENT

Dietary protein supplement (protein-enriched milk with 0,2 % fat). 0,33 l each day for 10 weeks.

Protein supplement; Strength training + protein supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65
• Frail or pre-frail according to the Fried Frailty Criteria or Short Physical Performance Battery (SPPB) score \<6.
• Mini Mental State Examination score \> 18

You may not qualify if:

• Diseases or injuries contraindicating participation
• Lactose intolerance
• Allergy to milk
• Allergy towards local anesthetics (xylocain)
• Use of anticoagulants that cannot be discontinued prior to the muscle biopsy

Sponsors & Collaborators

• Truls Raastad: lead
• University of Padova: collaborator
• University of Copenhagen: collaborator
• Tine: collaborator

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0863, Norway

Location

MeSH Terms

Conditions

Sarcopenia; Frailty

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

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 Officials

• Truls Raastad, Prof.

  Norwegian School of Sport Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects and testers will not be blinded. All analyses of muscle samples will be performed blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: October 31, 2017
• Study Start: September 1, 2016
• Primary Completion: December 20, 2017
• Study Completion: March 1, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)