NCT05009654

Brief Summary

The primary aim of the current research project is to explore whether leucine stimulates carnitine transport, and thus affecting muscle carnitine content. A secondary aim of this project is to investigate the effect of carnitine with leucine supplementation on muscle strength and body composition.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

August 5, 2021

Last Update Submit

August 11, 2021

Conditions

Muscle Loss

Outcome Measures

Primary Outcomes (1)

  • Muscle Carnitine Concentration using UPLC-MS/MS

    vastus lateralis muscle biopsy taken before and after the supplementation procedure (\~20 cm proximal to the knee joint using a thin biopsy needle); carnitine concentration determined using ultra performance liquid chromatography - tandem mass spectrometer (UPLC-MS/MS) method

    24 weeks

Secondary Outcomes (2)

  • Muscle Strength using Biodex System 4 Pro dynamometer

    24 weeks

  • Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).

    24 weeks

Study Arms (2)

carnitine + leucine

EXPERIMENTAL

1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks

Dietary Supplement: L-carnitineDietary Supplement: L-leucine

leucine

PLACEBO COMPARATOR

4000 mg L-leucine per day for 24 weeks

Dietary Supplement: L-leucine

Interventions

L-carnitineDIETARY_SUPPLEMENT
Also known as: L-carnitine-L-tartrate
carnitine + leucine
L-leucineDIETARY_SUPPLEMENT
carnitine + leucineleucine

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • must be able to swallow tablets

You may not qualify if:

  • cardiovascular disease
  • liver disease
  • kidney disease
  • neuromuscular disease
  • gastrointestinal disorders (including stomach ulcers and erosions)
  • diabetes
  • other severe chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscular Atrophy

Interventions

CarnitineLeucine

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 17, 2021

Study Start

October 1, 2016

Primary Completion

May 15, 2017

Study Completion

January 31, 2018

Last Updated

August 17, 2021

Record last verified: 2021-08