NCT03907592

Brief Summary

The primary aim of the current research project is to explore whether nutritional supplementation and resistance training might be combined to produce synergistic effects in the prevention of muscle loss during aging. A secondary aim of this project is to investigate the effects of carnitine with leucine supplementation, in comparison to carnitine supplementation alone, on muscle strength and body composition. The hypothesis is that resistance training combined with nutritional supplementation have a more beneficial effect than resistance training alone in the prevention of muscle loss during aging. Leucine stimulates carnitine transport into the muscle cells, which improve mitochondrial capacity. Modification in energetic of skeletal muscle affects the body composition and muscle performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

April 6, 2019

Last Update Submit

April 8, 2019

Conditions

Keywords

L-CarnitineResistance trainingMagnetic resonance imagingMuscle functionAgingLeucine

Outcome Measures

Primary Outcomes (1)

  • Volumetric changes in knee extensor muscle

    Volumetric examination of cross section area (CSA) of knee extensor muscles determined by a 1.5 T MRI scanner.

    Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

Secondary Outcomes (2)

  • Changes in the strength of muscle knee extensor

    Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

  • Changes in Lean Body Mass

    Values at baseline will be compared to values recorded at 12 and at 24 weeks after supplementation and training procedure.

Study Arms (3)

L-carnitine Group

EXPERIMENTAL

Group participated in the training protocol and supplemented by 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout 24 weeks.

Dietary Supplement: L-carnitine supplementationProcedure: Resistance training

Leucine Group

EXPERIMENTAL

Group participated in the training protocol and supplemented by 4000mg of L-leucine per day throughout 24 weeks.

Dietary Supplement: Leucine supplementationProcedure: Resistance training

Control Group

EXPERIMENTAL

Group participated in the training protocol without any supplementation throughout 24 weeks.

Procedure: Resistance training

Interventions

L-carnitine supplementationDIETARY_SUPPLEMENT

Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.

L-carnitine Group
Leucine supplementationDIETARY_SUPPLEMENT

Supplementation of 4000 mg L-leucine per day throughout the study period.

Leucine Group

Resistance training at the gym, twice a week for 24 weeks (48 training units in total).

Control GroupL-carnitine GroupLeucine Group

Eligibility Criteria

Age60 Years - 72 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged-matched, no chronic disease, doctor's note about the lack of restrictions to perform resistance exercises

You may not qualify if:

  • diabetes, liver, heart and renal diseases, gastric problems, as well as using the vitamin supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education and Sport

Gdansk, Pomeranian Voivodeship, 80-336, Poland

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Robert A Olek, PhD

    Gdansk University of Physical Education and Sport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 9, 2019

Study Start

September 1, 2017

Primary Completion

July 7, 2018

Study Completion

July 7, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations