Protein Supplementation and Muscle Function in the Elderly

NCT03815201 | Unknown

• 1 other identifier: BasqueHS
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is a geriatric syndrome associated with functional lost and disability, leading to an increase in healthcare costs. Physical activity, especially multicomponent exercise program, seems to be the most effective intervention to delay disability in elderly patients. The main objective of the current study is to determine if leucine-enriched protein ingestion after exercise training helps to increase muscle mass gains. Secondary outcomes will be to analyse the different effects among cognitive performance, depressive symptoms, disability, inflammation, quality of life and use of healthcare services. A randomized controlled trial will be carried out to assess the objectives of the current study. Participants will be randomized into two different groups (N=40, each one): an exercise training control group and exercise training plus leucine-enriched protein ingestion intervention group. Exercise training will take 12 weeks of supervised training intervention and 12 weeks of non-supervised training intervention for both groups. Biological samples will be analysed in Biodonostia Health Research Institute and in the University of the Basque Country (UPV/EHU).

Conditions

Sarcopenia

Keywords

muscle mass; protein supplementation; leucine; elderly; exercise training

Outcome Measures

Primary Outcomes (1)

• muscle mass change

  muscle mass measured using dual-energy x-ray absorptiometry method

  change from baseline muscle mass assessment to 12 weeks of supervised intervention

Secondary Outcomes (1)

• Physical fitness change

  change from baseline assessment to 12 weeks of supervised intervention and to the end of the study (at 6 months)

Study Arms (2)

Group 1

PLACEBO COMPARATOR

exercise training program: 2 non-consecutive days per week during 12 weeks plus placebo ingestion post-training

Other: Group 1

Group 2

ACTIVE COMPARATOR

exercise training program: 2 non-consecutive days per week during 12 weeks plus leucine-enriched protein supplementation post-training

Dietary Supplement: Group 2

Interventions

Group 2 DIETARY_SUPPLEMENT

leucine-enriched protein supplementation during the first 1/2 hour post-training

Group 2

Group 1 OTHER

placebo, an energy-matched mixture, during the first 1/2 hour post-training

Group 1

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age: \> 70 years
• Punctuation at the Mini Mental State Questionnaire (MMSE): \> or = 20.
• Any patient that fulfill the European Working Group on Sarcopenia in Older People (EWGSOP) criteria for sarcopenia diagnosis.
• Anyone who is able to walk alone, to walk using a walking stick or a walking frame, or to walk using parallel walking bars.
• Anyone able to understand the instructions or what is being said.
• Anyone signing the informed consent.

You may not qualify if:

• Chronic kidney disease
• To have suffered a heart attack in the last 3 months.
• To be unable to walk.
• To have suffered any fracture of the upper or lower limbs in the last 3 months.
• Anyone suffering from severe dementia.
• Autoimmune neuromuscular disorders (for example, myasthenia gravis, Guillain-Barré syndrome, inflammatory myopathies) or amyotrophic lateral sclerosis.
• Anyone refusing to sign the informed consent, or anyone who does not agree to the study protocol.

Sponsors & Collaborators

• Basque Health Service: lead
• University of the Basque Country (UPV/EHU): collaborator
• Hospital Universitario de Álava: collaborator

Study Sites (1)

Hospital Santiago Apostol

Vitoria-Gasteiz, Alava, 1004, Spain

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ariadna Besga

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Amasene

CONTACT

945007728; mamasene001@ehu.eus

Iñaki Echeverria

CONTACT

inaki.echeverriag@ehu.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 24, 2019
• Study Start: October 31, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 31, 2019
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

ES (1)